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AtRial Cardiopathy and Antithrombotic Drugs In prevention After cryptogenic stroke (ARCADIA)

Description:

ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. Eleven hundred subjects will be recruited over 2.5 years at 120 sites in the NINDS StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 4 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage.

Principal Investigator: Benjamin Miller

Sex: All

Age: 45 Years to old

Phase: Phase III

This study is NOT accepting healthy volunteers

System ID: STUDY00001759

IRB Number: STUDY00001759

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Inclusion Criteria:

Age ≥ 45 years. Clinical diagnosis of ischemic stroke + brain imaging to rule out hemorrhagic stroke. Modified Rankin Scale (MRS) score ≤ 4. Ability to be randomized within 3 to 180 days after stroke onset. ESUS, defined as all of the following: Stroke detected by CT or MRI that is not lacunar. Lacunar is defined as a subcortical (this includes pons and midbrain) infarct in the distribution of the small, penetrating cerebral arteries whose largest dimension is ≤1.5 cm on CT or ≤2.0 cm on MRI diffusion images/<1.5 cm on T2 weighted MR images. The following are not considered lacunes: multiple simultaneous small deep infarcts, lateral medullary infarcts, and cerebellar infarcts. Patients with a clinical lacunar stroke syndrome and no infarct on imaging are excluded. Absence of extracranial or intracranial atherosclerosis causing ≥50 percent luminal stenosis of the artery supplying the area of ischemia. Patients must undergo vascular imaging of the extracranial and intracranial vessels using either catheter angiography, CT angiogram (CTA), MR angiogram (MRA), or ultrasound, as considered appropriate by the treating physician and local principal investigator. No major-risk cardioembolic source of embolism, including intracardiac thrombus, mechanical prosthetic cardiac valve, atrial myxoma or other cardiac tumors, moderate or severe mitral stenosis, myocardial infarction within the last 4 weeks, left ventricular ejection fraction <30 percent, valvular vegetations, or infective endocarditis). Patent foramen ovale is not an exclusion. All patients must undergo electrocardiogram, transthoracic or transesophageal echocardiography (TTE or TEE) and at least 24 hours of cardiac rhythm monitoring (Holter monitor or telemetry or equivalent). Additional cardiac imaging, such as cardiac MRI, or cardiac CT will be performed at the discretion of the local treating physician and principal investigator. Additional cardiac rhythm monitoring, such as monitored cardiac outpatient telemetry (MCOT) or an implanted cardiac monitor, will be at the discretion of the treating physician and local principal investigator. No other specific cause of stroke identified, such as arteritis, dissection, migraine, vasospasm, drug abuse, or hypercoagulability. Special testing, such as toxicological screens, serological testing for syphilis, and tests for hypercoagulability, will be performed at the discretion of the treating physician and local principal investigator.

Exclusion Criteria:

History of atrial fibrillation (AF), AF on 12-lead ECG, or any AF of any duration during heart-rhythm monitoring prior to randomization. Clear indication for treatment-dose anticoagulant therapy, such as venous thromboembolism or a mechanical heart valve. Need for antiplatelet agent, such as aspirin or clopidogrel History of spontaneous intracranial hemorrhage. Chronic kidney disease with serum creatinine ≥2.5 mg/dL.For Canadian sites only, estimated creatinine clearance (eCrCl) <15 mL/min is also an exclusion criterion. Active hepatitis or hepatic insufficiency with Child-Pugh score B or C. Clinically significant bleeding diathesis. Unresolved anemia (hemoglobin <9 g/dL) or thrombocytopenia (<100 x 10E9/L). Clinically significant gastrointestinal bleeding within the past year (e.g., not due to external hemorrhoids). At risk for pregnancy: premenopausal or postmenopausal woman within 12 months of last menses without a negative pregnancy test or not committing to adequate birth control, which includes an oral contraceptive, two methods of barrier birth control such as condom with or without spermicidal lubricant + diaphragm, or abstinence. Known allergy or intolerance to aspirin or apixaban. Concomitant participation in another clinical trial involving a drug or acute stroke intervention. Considered by the investigator to have a condition that precludes follow-up or safe participation in the trial. Inability of either participant or surrogate to provide written, informed consent for trial participation.

Interventions: Apixaban, Aspirin, Apixaban, Aspirin

Conditions: Stroke

Keywords: Clinics and Surgery Center (CSC)

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OMS721-IGA-001: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS - IGAN)

Description:

This is a Phase 3, double-blind, randomized, placebo-controlled, study in patients aged 18 years and above with a biopsy-confirmed diagnosis of IgAN and with 24-hour UPE that is > 1 g/day at baseline. During the study, all patients will continue optimized renin-angiotensin system (RAS) blockade. The study consists of five periods: Screening, Run-In, Initial Treatment (Weeks 1-12), Response Evaluation (Weeks 13-24), and Follow-Up (Weeks 25 to end-of-study). The study duration for each patient is expected to last up to 160 weeks.

Principal Investigator: Patrick Nachman

Sex: All

Age: 18 Years to old

Phase: Phase 3

This study is NOT accepting healthy volunteers

System ID: STUDY00002971

IRB Number: STUDY00002971

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Inclusion Criteria:

Age 18 years or older at the onset of Screening Biopsy confirmed diagnosis of IgAN within 8 years prior to Screening Proteinuria of > 1 g/day within 6 months prior to Screening or uPCR > 0.75 by spot urine at Screening Mean of two proteinuria measurements > 1 g/day at baseline Estimated glomerular filtration rate of ≥ 30 mL/min/1.73 m2 at Screening and baseline

Exclusion Criteria:

Treatment with immunosuppressants (e.g., azathioprine or cyclophosphamide), or cytotoxic drugs, for IgA within 8 weeks prior to Screening. Treatment with immunosuppressants or cytotoxic drugs for IgAN is not allowed during the Run-In Period. Treatment with immunosuppressants are allowed if such treatment is for indications other than IgAN. Treatment with eculizumab within 8 weeks prior to Screening. Treatment with eculizumab is not allowed during the Run-In Period. Treatment with systemic corticosteroids within 8 weeks prior to Screening. Treatment with systemic corticosteroids is not allowed during the Run-In Period. Uncontrolled BP, a systolic BP of > 150 mmHg and a diastolic BP of > 100 mmHg at rest despite the combination of two or more anti-hypertensives including ACEIs, ARBs, or direct renin inhibitors at Screening and baseline Female patients who are pregnant, breast feeding, or planning to become pregnant up through 12 weeks after the last dose of study drug, including possible retreatments Clinical or biological evidence of Type 1 diabetes mellitus (DM), or poorly controlled DM with hemoglobin A1c > 7.5 or with evidence of diabetic nephropathy on biopsy, systemic lupus erythematosus, IgA vasculitis (Henoch-Schonlein purpura), secondary IgAN, or other renal disease during Screening and Run-In History of renal transplantation Have a known hypersensitivity to any constituent of the investigational product Rapidly progressive glomerulonephritis Significant abnormalities in clinical laboratory values History of human immunodeficiency virus (HIV), evidence of immune suppression, active HCV infection (patients with positive anti-HCV antibody but a non-detected HCV RNA PCR can enroll), HBV infection (patients with positive HBsAg are excluded. For patients with isolated positive anti-HBc antibody, HBV DNA test by PCR must be non-detectable to enroll). Diagnosis of a malignancy except for adequately treated and cured basal or squamous cell skin cancer, curatively treated in situ disease, or other cancer from which the patient has been disease-free for ≥ 5 years Have received any other investigational drug or device or experimental procedures within 30 days of the Screening Visit (SV)

Interventions: OMS721, Vehicle (D5W or saline), OMS721, Vehicle (D5W or saline)

Conditions: IgA Nephropathy

Keywords: Clinics and Surgery Center (CSC)

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Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back Pain (PACBACK) (PACBACK)

Principal Investigator: Gert Bronfort

Sex: All

Age: 18 Years to old

Phase: Phase 3

This study is NOT accepting healthy volunteers

System ID: SITE00000150

IRB Number: SITE00000150

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Interventions: Supported-Self Management (SSM), Spinal Manipulation Therapy (SMT), SMT + SSM, Standard Medical Care (SMC), Supported-Self Management (SSM), Spinal Manipulation Therapy (SMT), SMT + SSM, Standard Medical Care (SMC)

Conditions: Acute Pain, Low Back Pain, Mechanical

Keywords: acute/subacute low back pain, randomized clinical trial, self-management, behavioral modification, spinal manipulation therapy, standard medical care, secondary prevention

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RPC01-3202: INDUCTION STUDY #2 - A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ORAL OZANIMOD AS INDUCTION THERAPY FOR MODERATELY TO SEVERELY ACTIVE CROHN S DISEASE

Description:

This is a Phase 3, randomized, double-blind, placebo-controlled study to determine the effect of oral ozanimod as an induction treatment for subjects with moderately to severely active CD, defined as a CDAI score ≥ 220 to ≤ 450. Approximately 600 subjects with active clinical symptoms and mucosal inflammation will be randomized in a 2:1 ratio to receive either ozanimod or placebo. Subjects will be stratified by prior biologic use and corticosteroid use at baseline. Approximately 50% of subjects with a history of treatment with marketed biologic agents (eg, TNF antagonists, anti-IL-12/23 and anti-integrin therapy) will be recruited. This limit will ensure the enrollment of subjects who have failed or been intolerant to corticosteroids or immunomodulators but never failed a TNF antagonist.

Principal Investigator: Eugenia Shmidt

Sex: All

Age: 18 Years to 75 Years old

Phase: Phase 3

This study is NOT accepting healthy volunteers

System ID: STUDY00003227

IRB Number: STUDY00003227

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Interventions: Ozanimod, Placebo, Ozanimod, Placebo

Conditions: Digestive & Liver Health

Keywords: Clinics and Surgery Center (CSC), inflammatory bowel disease

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Randomization of Cytarabine Monotherapy Versus Standard-of-Care Vinblastine/Prednisone For Frontline Treatment of Langerhans Cell Histiocytosis (TXCH LCH0115)

Description:

The purpose of this research study is to compare previously used vinblastine/prednisone to single therapy with cytarabine for LCH. We will evaluate the utility of an imaging study called a positron emission tomography (PET) scan to more accurately assess areas of LCH involvement not otherwise seen in other imaging studies as well as response to therapy. We also want to identify if genetic and other biomarkers (special proteins in patient's blood and in patient's cancer) relate to the response of patients LCH to study treatment.

Principal Investigator: Lucie Turcotte

Sex: All

Age: to 21 Years old

Phase: Phase 3

This study is NOT accepting healthy volunteers

System ID: STUDY00008859

IRB Number: STUDY00008859

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Inclusion Criteria:

Patient must have biopsy-confirmed diagnosis of Langerhans cell histiocytosis. Patient must be between 0-21 years of age. Patient must have a Karnofsky performance score ≥ 50% or Lansky performance score ≥ 50%.

Exclusion Criteria:

Patient may not have received any prior systemic cytotoxic or other chemotherapies for LCH or any other malignant disorder prior to the initiation of protocol therapy on TXCH LCH0115 with the exception of: Steroid pretreatment: Systemic glucocorticosteroids (prednisone, methylprednisone, dexamethasone, etc.) for less than or equal to 120 hours (5 days) in the 7 days prior to initiating protocol therapy or for less than or equal to 336 hours (14 days) in the 28 days before the initiation of protocol therapy does not affect eligibility. The dose of steroid previously given does not affect eligibility. Patients who have only received surgical or radiation therapy, intralesional injection of steroids, inhalational steroids, systemic mineralocorticoids (hydrocortisone), or topical steroids may also be enrolled. Patient may not have disease limited to a single skin or bone site, with the following exceptions: Central Nervous System (CNS) risk lesions/special site disease: patients with single bone sites that are CNS-risk (sphenoid, mastoid, orbital, zygomatic, ethmoid, maxillary, or temporal bones, the cranial fossa, pituitary gland or neurodegenerative disease) or are "special sites" (odontoid peg, vertebral lesion with intraspinal soft tissue extension) require systemic therapy as standard of care and thus are eligible for the study. Functionally critical lesions: A single lesion not described above which may cause "functionally critical anatomic abnormality" wherein attempts at local therapy (such as surgical curettage or radiation) would cause unacceptable morbidity. These patients may be enrolled with written approval of the Coordinating Center PI or Vice-Chair and documentation of the rationale justifying systemic therapy. Asynchronous multisite LCH presentation: A patient may also have any single site of disease involvement at the time of enrollment if they previously had at least one other site of LCH disease in the past (which may have been treated with local therapy/surgery as described), as long as no systemic therapy was previously given per protocol guidelines. Patient may not have severe renal disease (creatinine greater than 3 times normal for age OR creatinine clearance < 50 ml/m2/1.73m^2). Patient may not have severe hepatic disease (direct bilirubin greater than 3 mg/dl OR aspartate aminotransferase (AST) greater than 500 IU/L), unless hepatic injury is due to LCH. Female patients may not be pregnant or breastfeeding. Patients of reproductive potential not willing to use an adequate method of birth control for the duration of the study. Patients who are HIV positive may not be enrolled. NOTE: Patients excluded for laboratory abnormalities or performance score only may be enrolled on the study with written approval from the Coordinating Center PI or Vice-Chair.

Interventions: Cytarabine, Vinblastine/prednisone, Cytarabine, Vinblastine/prednisone

Conditions: Langerhans Cell Histiocytosis

Keywords: vinblastine, prednisone, cytarabine, Langerhans Cell Histiocytosis (LCH)

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A randomized, controlled, multi-center, safety and efficacy study of FCR001 cell-based therapy relative to a tacrolimus and mycophenolate-based regimen in de novo living donor renal transplant recipients, and safety in FCR001 donors (FREEDOM-1)

Description:

The purpose of this study is to assess the safety, efficacy and overall benefit of FCR001 cell therapy in de novo living donor renal transplantation, relative to a standard-of-care control regimen including tacrolimus, mycophenolate, antibody induction, and corticosteroids. FCR001 is a novel, cryopreserved allogeneic somatic cell therapy, derived from mobilized peripheral blood mononuclear cells from the same donor as the allograft, and containing hematopoietic progenitor cells, facilitating cells and αβ T cells. The rationale is to establish durable chimerism and donor-specific tolerance in the recipient enabling freedom from chronic IS and its associated toxicities.

Principal Investigator: Erik Finger

Sex: All

Age: 18 Years to old

Phase: Phase 3

This study is NOT accepting healthy volunteers

System ID: STUDY00006880

IRB Number: STUDY00006880

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Main

Inclusion Criteria:

Recipient age ≥18 years. Donor age ≥18 and ≤60 years at time of signing informed consent. Recipients of a first or second living donor kidney transplant Donor willing to undergo mobilization, apheresis and 12-month safety follow-up and meet all local standard eligibility criteria to donate stem cells for allogeneic transplantation. Recipient meets all local standard eligibility criteria for allogeneic stem cell transplant. Donors must be deemed eligible as per the requirements of 21CFR1271. Main Recipient and Donor

Exclusion Criteria:

Recipient and donor who are identical twins. Recipient or donor with history of malignancy or premalignant syndrome (e.g., myelodysplastic syndrome, monoclonal gammopathy of renal significance [MGRS], monoclonal gammopathy of unknown significance [MGUS]) of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. Recipient or donor with known bone marrow aplasia. Main Recipient-only

Exclusion Criteria:

Multi-organ or stem cell transplant recipient. Calculated panel reactive antibodies >80%. Recipient is blood type ABO incompatible with donor. Presence of donor-specific antibodies (DSA) (positive result) at any time pre-transplant. Recipient who is human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) positive. Recipient with any baseline condition requiring or anticipated will require chronic or intermittent use of systemic steroids or other IS (eg, autoimmune disease, asthma) throughout the course of the study. Recipient with a BMI < 18 or > 35 kg/m2. Recipient requiring systemic anticoagulation, (eg, for hyper-coagulation disorders, deep vein thrombosis, atrial fibrillation) that cannot be temporarily interrupted which would preclude renal biopsy. Main Donor-only

Exclusion Criteria:

Biologically unrelated (i.e., no genetic relationship) female donor transplant to male recipient.

Interventions: FCR001, FCR001

Conditions: Transplanted Organ Rejection

Keywords: Kidney Transplant, Stem cell therapy, Anti-rejection medications, Living donor kidney transplant, Immune tolerance, Immunosuppression, Immunosuppressive medication, Organ transplant rejection

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COG ACNS1831 - A Phase 3 Randomized Study of Selumetinib (IND # 77782) versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG)

Description:

This study is a randomized phase 3 study comparing selumetinib to Carboplatin and Vincristine (CV) in previously untreated NF1-associated LGG. This study will compare both the event-free survival (EFS) and visual functional outcomes between the 2 randomized arms.

Principal Investigator: Christopher Moertel, MD

Sex: All

Age: 2 Years to 21 Years old

Phase: Phase 3

This study is NOT accepting healthy volunteers

System ID: STUDY00008583

IRB Number: STUDY00008583

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Inclusion Criteria:

Patients must be >= 2 years and =< 21 years at the time of enrollment Patients must have a body surface area (BSA) of >= 0.5 m^2 at enrollment Patients must have neurofibromatosis type 1 (NF1) based on clinical criteria and/or germline genetic testing Patients must be newly diagnosed or have previously diagnosed NF-1 associated LGG that has not been treated with any modality other than surgery For patients with optic pathway gliomas (OPGs): Newly-diagnosed patients with OPG are eligible if there are neurologic symptoms (including visual dysfunction, as defined below) or other exam findings associated with the tumor Previously-diagnosed patients with OPG are eligible if they have new or worsening neurologic symptoms (including visual dysfunction, as defined below) or have tumor growth For both newly-diagnosed and previously-diagnosed OPG, the patient may be eligible, irrespective of whether there has been tumor growth or other neurological symptoms or worsening, if they meet at least one of the following visual criteria: Visual worsening, defined as worsening of visual acuity (VA) or visual fields (VF) documented within the past year (by examination or history); OR Significant visual dysfunction (defined as VA worse than normal for age by 0.6 logMAR [20/80, 6/24, or 2.5/10] or more in one or both eyes) For patients with LGG in other locations (i.e., not OPGs): Newly-diagnosed patients with LGG are eligible if there are neurologic symptoms or other exam findings associated with the tumor NOTE: Newly-diagnosed patients with LGG without associated neurologic symptoms or exam findings are not eligible Previously-diagnosed patients with LGG are eligible if they have new or worsening neurologic symptoms or have tumor growth Although not required, if a biopsy/tumor resection is performed, eligible histologies will include all tumors considered LGG or low-grade astrocytoma (World Health Organization [WHO] grade I and II) by 5th edition WHO classification of central nervous system (CNS) tumors with the exception of subependymal giant cell astrocytoma Patients must have two-dimensional measurable tumor >= 1 cm^2 Patients with metastatic disease or multiple independent primary LGGs are allowed on study Creatinine clearance or radioisotope glomerular filtration Rate (GFR) >= 70 mL/min/1.73 m^2 OR a serum creatinine based on age/gender (within 7 days prior to enrollment) as follows: Age; maximum serum creatinine (mg/dL) 2 to < 6 years; 0.8 (male) and 0.8 (female) 6 to < 10 years; 1 (male) and 1 (female) 10 to < 13 years; 1.2 (male) and 1.2 (female) 13 to < 16 years; 1.5 (male) and 1.4 (female) >= 16 years; 1.7 (male) and 1.4 (female) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment) (children with a diagnosis of Gilbert's syndrome will be allowed on study regardless of their total and indirect [unconjugated] bilirubin levels as long as their direct [conjugated] bilirubin is < 3.1 mg/dL) Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x upper limit of normal (ULN) = 135 U/L (within 7 days prior to enrollment). For the purpose of this study, the ULN for SGPT is 45 U/L Albumin >= 2 g/dL (within 7 days prior to enrollment) Left ventricular ejection fraction (LVEF) >= 53% (or institutional normal; if the LVEF result is given as a range of values, then the upper value of the range will be used) by echocardiogram (within 4 weeks prior to enrollment) Corrected QT (QTc) interval =< 450 msec by electrocardiography (EKG) (within 4 weeks prior to enrollment) Absolute neutrophil count >= 1,000/uL (unsupported) (within 7 days prior to enrollment) Platelets >= 100,000/uL (unsupported) (within 7 days prior to enrollment) Hemoglobin >= 8 g/dL (may be supported) (within 7 days prior to enrollment) Patients with a known seizure disorder should be stable and should have not experienced a significant increase in seizure frequency within 2 weeks prior to enrollment Patients 2-17 years of age must have a blood pressure that is =< 95th percentile for age, height, and gender at the time of enrollment. Patients >= 18 years of age must have a blood pressure =< 130/80 mmHg at the time of enrollment (with or without the use of antihypertensive medications). Note: Adequate blood pressure can be achieved using medication for the treatment of hypertension All patients must have ophthalmology toxicity assessments performed within 4 weeks prior to enrollment For all patients, an MRI of the brain (with orbital cuts for optic pathway tumors) and/or spine (depending on the site(s) of primary disease) with and without contrast must be performed within 4 weeks prior to enrollment For patients who undergo a surgery on the target tumor (not required), a pre- and post-operative* MRI of the brain (with orbital cuts for optic pathway tumors) or spine (depending on the site(s) of primary disease) with and without contrast must also be performed within 4 weeks prior to enrollment The post-operative MRIs should be performed ideally within 48 hours after surgery if possible Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age Patients must have the ability to swallow whole capsules Patients must have receptive and expressive language skills in English or Spanish to complete the quality of life (QOL) and neurocognitive assessments All patients and/or their parents or legal guardians must sign a written informed consent. All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.

Exclusion Criteria:

Patients must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant. Prior surgical intervention is permitted Patients with a concurrent malignancy or history of treatment (other than surgery) for another tumor within the last year are ineligible Patients may not be receiving any other investigational agents Patients with any serious medical or psychiatric illness/ condition, including substance use disorders likely in the judgement of the investigator to interfere or limit compliance with study requirements/treatment are not eligible Patients who, in the opinion of the investigator, are not able to comply with the study procedures are not eligible Female patients who are pregnant are not eligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential Lactating females who plan to breastfeed their infants are not eligible Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for 12 weeks after stopping study therapy are not eligible Note: Women of child-bearing potential and males with sexual partners who are pregnant or who could become pregnant (i.e., women of child-bearing potential) should use effective methods of contraception for the duration of the study and for 12 weeks after stopping study therapy to avoid pregnancy and/or potential adverse effects on the developing embryo Cardiac conditions: Known genetic disorder that increases risk for coronary artery disease. Note: The presence of dyslipidemia in a family with a history of myocardial infarction is not in itself an exclusion unless there is a known genetic disorder documented Symptomatic heart failure New York Heart Association (NYHA) class II-IV prior or current cardiomyopathy Severe valvular heart disease History of atrial fibrillation Ophthalmologic conditions: Current or past history of central serous retinopathy Current or past history of retinal vein occlusion or retinal detachment Patients with uncontrolled glaucoma If checking pressure is clinically indicated, patients with intraocular pressure (IOP) > 22 mmHg or ULN adjusted by age are not eligible Ophthalmological findings secondary to long-standing optic pathway glioma (such as visual loss, optic nerve pallor, or strabismus) or longstanding orbito-temporal plexiform neurofibroma (PN), such as visual loss, strabismus) will NOT be considered a significant abnormality for the purposes of the study Treatments and/or medications patient is receiving that would make her/him ineligible, such as: Supplementation with vitamin E greater than 100% of the daily recommended dose. Any multivitamin containing vitamin E must be stopped prior to study enrollment even if less than 100% of the daily recommended dosing for vitamin E Surgery within 2 weeks prior to enrollment, with the exception of surgical placement for vascular access or cerebrospinal fluid (CSF) diverting procedures such as endoscopic third ventriculostomy (ETV) and ventriculo-peritoneal (VP) shunt. Note: Patients must have healed from any prior surgery prior to enrollment Patients who have an uncontrolled infection are not eligible

Interventions: Carboplatin, Magnetic Resonance Imaging, Quality-of-Life Assessment, Questionnaire Administration, Selumetinib Sulfate, Vincristine Sulfate, Carboplatin, Magnetic Resonance Imaging, Quality-of-Life Assessment, Questionnaire Administration, Selumetinib Sulfate, Vincristine Sulfate

Conditions: Low Grade Glioma, Neurofibromatosis Type 1, Visual Pathway Glioma

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A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy? System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression (RECOVER)

Description:

This blinded, randomized, multicenter controlled study is intended to collect evidence that VNS Therapy as an adjunctive therapy improves health outcomes for patients with TRD. The objective of this study is to determine whether active VNS Therapy treatment improves health outcomes for Treatment Resistant Depression (TRD) subjects compared to a no stimulation control in depressive symptoms. This prospective, multicenter trial is composed of two parts: - The RCT and Follow-up (RCT) is a randomized, controlled, blinded trial to determine if active VNS Therapy treatment compared to a no stimulation control improves depressive symptoms. - The Longitudinal Registry (LR) is an observational, open label, single arm study aimed at assessing the long-term effectiveness and safety of VNS Treatment.

Principal Investigator: Ziad Nahas

Sex: All

Age: 18 Years to old

Phase: N/A

This study is NOT accepting healthy volunteers

System ID: STUDY00009412

IRB Number: STUDY00009412

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Interventions: Vagus Nerve Stimulation (VNS), Vagus Nerve Stimulation (VNS)

Conditions: Treatment Resistant Depression

Keywords: VNS, Depression, TRD

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PRI-VENT FSGS: Preemptive Rituximab to Prevent Recurrent Focal Segmental Glomerulosclerosis Post-Transplant

Description:

PRI-VENT FSGS is a phase III, multicenter, randomized, open label, clinical trial to test the hypothesis that plasmapheresis plus rituximab prior to kidney transplantation can prevent recurrent FSGS in children and adults.

Principal Investigator: Michelle Rheault

Sex: All

Age: 1 Year to 65 Years old

Phase: Early Phase 1

This study is NOT accepting healthy volunteers

System ID: STUDY00004388

IRB Number: STUDY00004388

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In order to be eligible to participate in this study, an individual must meet all of the following criteria: Age 1-65 years at the time of kidney transplant Biopsy proven diagnosis of primary FSGS or minimal change disease History of nephrotic syndrome (proteinuria, edema, hypoalbuminemia) First kidney transplant or second or third transplant with a history of recurrent FSGS in the first or second kidney transplant. The patient (if ≥18 years old) or the child's parent or guardian must be able and willing to give written informed consent and comply with the requirements of the study protocol. Patient assent if <18 years old will be required per local IRB requirements. Negative urine pregnancy test prior to randomization (for females who are post-menarche). Males and females of reproductive potential (sexually active in boys or post-menarche in girls) must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment with rituximab. An individual who meets any of the following criteria will be excluded from participation in this study:
• Known genetic cause of FSGS 2. Patients with FSGS secondary to another condition (obesity, viral infection, medications, etc.) 3. 4. Received rituximab within 1 year prior to transplant 5. Known hypersensitivity to rituximab, to any of its excipients, or to murine proteins 6. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies 7. Known active bacterial, viral (e.g. HIV, hepatitis B, hepatitis C), fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening visit.
• Participation in another therapeutic trial within 30 days of enrollment or 5 half-lives of the investigational drug (whichever is longer) 9. ANC < 1.5 x 103 10. Hemoglobin: < 8.0 gm/dL 11. Platelets: < 100,000/mm 12. AST or ALT >2.5 x Upper Limit of Normal at the local institution's laboratory 13. History of drug, alcohol, or chemical abuse within 6 months prior to screening visit.
• Pregnant, lactating, or refusal of birth control in an adolescent of child-bearing potential 15. Concomitant malignancies or previous malignancies 16. History of psychiatric disorder that would interfere with normal participation in this protocol 17. History of significant cardiac (including arrhythmias) or pulmonary disease (including obstructive pulmonary disease) 18. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications 19. Inability to comply with study and follow-up procedures

Interventions: Rituximab, Plasmapheresis, Rituximab, Plasmapheresis

Conditions: Focal Segmental Glomerulosclerosis

Keywords: Clinics and Surgery Center (CSC)

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MultiStem Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2)

Description:

This study is evaluating the efficacy of MultiStem (drug) on functional outcome in participants with ischemic stroke.

Principal Investigator: Muhammad Affan

Sex: All

Age: 18 Years to old

Phase: Phase III

This study is NOT accepting healthy volunteers

System ID: STUDY00008000

IRB Number: STUDY00008000

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Interventions: MultiStem, Placebo, MultiStem, Placebo

Conditions: Ischemic Stroke

Keywords: adult stem cells, ischemic stroke

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COG AGCT1531 - A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors

Description:

This partially randomized phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Principal Investigator: Emily Greengard

Sex: All

Phase: Phase 3

This study is NOT accepting healthy volunteers

System ID: STUDY00003824

IRB Number: STUDY00003824

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Inclusion Criteria:

There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT [all sites]) Standard risk 1: Patient must be < 11 years of age at enrollment Standard risk 2: Patients must be >= 11 and < 25 years of age at enrollment Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with metastatic germ cell tumor (stage II or higher); histologic confirmation of a primary extracranial germ cell tumor in any of the categories outlined below is required of all patients at enrollment except for those who were initially diagnosed with stage I non-seminoma malignant GCT and later recur during observation post surgery off study; for these patients, if elevated tumor markers rise to > 5 x upper limit of normal (ULN) on at least 2 measurements taken at least 1 week apart, a diagnostic biopsy is not required for enrollment Low risk stage I immature teratoma (IT); site: ovarian; stage: Children's Oncology Group (COG) stage I, Federation of Gynecology and Obstetrics (FIGO) stage IA and IB; grade: 2 or 3; histology: pure immature teratoma (may contain microscopic foci of yolk sac tumor), mixed immature and mature teratoma, (no pathological evidence of MGCT); tumor markers: alpha-FP =< 1,000 ng/mL, beta-HCG institutional normal; all ages Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA, IB and IS; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; AJCC testicular stage IA IB, and IS; histology: must contain at least one of the following: may contain immature/mature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC, FIGO stage II-IV (International Germ Cell Consensus Classification [IGCCC] criteria DO NOT apply); histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) < 11 Standard risk 2 (SR2) Site: ovarian; stage: COG stage II and III, FIGO stage IC, II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) >= 11 and < 25 Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; tumor markers: must be IGCCC good risk; post op: alpha-FP < 1,000 ng/mL, beta-HCG < 5,000 IU/mL and lactate dehydrogenase (LDH) < 3.0 x normal; age (years) >= 11 and < 25 Site: extragonadal; stage: COG stage II; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) >= 11 and < 25 Notes: IGCCC criteria only apply to SR2 patients with a testicular primary tumor Use post-op tumor marker levels to determine IGCCC risk group Stage 1 seminoma patients are not eligible for the standard risk arms of the study For the low risk stage I non-seminoma MGCT and the standard risk arms, components of yolk sac tumor, embryonal carcinoma, or choriocarcinoma can be mixed with other forms of GCT, such as seminoma or mature or immature teratoma; if yolk sac tumor is the only malignant component present, then it must be deemed by the pathologist to be greater than a "microscopic component" of yolk sac tumor Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, 2 or 3; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age Organ function requirements apply ONLY to patients who will receive chemotherapy (SR1 and SR2 patients) Adequate renal function defined as: Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 (within 7 days prior to enrollment) OR A serum creatinine based on age/gender as follows (within 7 days prior to enrollment): (mg/dL) 1 month to < 6 months male: 0.4 female: 0.4 6 months to < 1 year male: 0.5 female: 0.5 1 to < 2 years male: 0.6 female: 0.6 2 to < 6 years male: 0.8 female: 0.8 6 to < 10 years male: 1 female: 1 10 to < 13 years male: 1.2 female: 1.2 13 to < 16 years: male: 1.5 female: 1.4 >= 16 years male: 1.7 female: 1.4 Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment) Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age (for the purpose of this study, the ULN for SGPT is 45 U/L) (within 7 days prior to enrollment) Peripheral absolute neutrophil count (ANC) >= 1,000/mm^3 (within 7 days prior to enrollment) AND Platelet count >= 100,000/mm^3 (within 7 days prior to enrollment) Patients enrolling on the standard risk arms must be medically fit to receive protocol treatment and with no contraindications to protocol treatment Eligibility criteria to participate in the pilot study of the AYA-Hears instrument (patient reported outcomes [PROs] of ototoxicity) Note: participants in group 1 will not receive AGCT1531 protocol-directed therapy; all other AYA-HEARS patients must be enrolled on the AGCT1531 SR2 arm in order to participate >= 11 and < 25 years old at enrollment Able to fluently speak and read English Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor Followed for cancer or survivorship care at one of the following institutions: Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Dana Farber/Harvard Cancer Center Hospital for Sick Children Children's Hospital of Eastern Ontario Oregon Health and Science University Seattle Children's Hospital Yale University

Exclusion Criteria:

Patients with any diagnoses not listed including: Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection) Pure dysgerminoma Pure mature teratoma Pure immature teratoma COG stage I, grade I Pure immature teratoma COG stage I, grade 2,3 with alpha-fetoprotein (AFP) >= 1000 ng/mL Pure immature teratoma COG stage II - IV or FIGO stage IC to IV "Poor risk" GCT (age >= 11 years old and COG stage IV ovarian, COG stage III or IV EG, or IGCCC intermediate or poor risk testicular), or Primary central nervous system (CNS) germ cell tumor Germ cell tumor with somatic malignant transformation Spermatocytic seminoma Patients must have had no prior systemic therapy for the current cancer diagnosis Patients must have had no prior radiation therapy with the exception of CNS irradiation of brain metastases; (this exception only applies to SR1 patients; any patients over age 11 with distant metastases to brain [stage IV disease] would be considered poor risk and therefore not eligible for this trial) Patients with significant, pre-existing co-morbid respiratory disease that contraindicate the use of bleomycin are ineligible for the standard risk arms of the trial Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients]) Lactating females who plan to breastfeed their infants; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients]) Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients])

Interventions: Best Practice, Biopsy, Biospecimen Collection, Bleomycin Sulfate, Carboplatin, Cisplatin, Computed Tomography, Etoposide, Magnetic Resonance Imaging, Pharmacogenomic Study, Pulmonary Function Test, Quality-of-Life Assessment, Questionnaire Administration, Best Practice, Biopsy, Biospecimen Collection, Bleomycin Sulfate, Carboplatin, Cisplatin, Computed Tomography, Etoposide, Magnetic Resonance Imaging, Pharmacogenomic Study, Pulmonary Function Test, Quality-of-Life Assessment, Questionnaire Administration

Conditions: Childhood Extracranial Germ Cell Tumor, Extragonadal Embryonal Carcinoma, Germ Cell Tumor, Malignant Germ Cell Tumor, Malignant Ovarian Teratoma, Stage I Ovarian Choriocarcinoma, Stage I Ovarian Embryonal Carcinoma AJCC v6 and v7, Stage I Ovarian Teratoma AJCC v6 and v7, Stage I Ovarian Yolk Sac Tumor AJCC v6 and v7, Stage I Testicular Choriocarcinoma AJCC v6 and v7, Stage I Testicular Embryonal Carcinoma AJCC v6 and v7, Stage I Testicular Seminoma AJCC v6 and v7, Stage I Testicular Yolk Sac Tumor AJCC v6 and v7, Stage II Ovarian Choriocarcinoma, Stage II Ovarian Embryonal Carcinoma AJCC v6 and v7, Stage II Ovarian Yolk Sac Tumor AJCC v6 and v7, Stage II Testicular Choriocarcinoma AJCC v6 and v7, Stage II Testicular Embryonal Carcinoma AJCC v6 and v7, Stage II Testicular Yolk Sac Tumor AJCC v6 and v7, Stage III Ovarian Choriocarcinoma, Stage III Ovarian Embryonal Carcinoma AJCC v6 and v7, Stage III Ovarian Yolk Sac Tumor AJCC v6 and v7, Stage III Testicular Choriocarcinoma AJCC v6 and v7, Stage III Testicular Embryonal Carcinoma AJCC v6 and v7, Stage III Testicular Yolk Sac Tumor AJCC v6 and v7, Stage IV Ovarian Choriocarcinoma, Stage IV Ovarian Embryonal Carcinoma AJCC v6 and v7, Stage IV Ovarian Yolk Sac Tumor AJCC v6 and v7, Testicular Mixed Choriocarcinoma and Embryonal Carcinoma, Testicular Mixed Choriocarcinoma and Teratoma, Testicular Mixed Choriocarcinoma and Yolk Sac Tumor

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Multi-arm Optimization of Stroke Thrombolysis (MOST)

Description:

This study is designed to find out whether adding one of two blood-thinning medications, argatroban or eptifibatide, to the standard treatment after a stroke helps to decrease the impact of strokes and is safe. Both are FDA-approved blood thinners, but are not approved for treating strokes.

Principal Investigator: Oladi Bentho

Sex: All

Age: 18 Years to old

Phase: Phase 3

This study is NOT accepting healthy volunteers

System ID: STUDY00006255

IRB Number: STUDY00006255

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Inclusion Criteria:

Acute ischemic stroke patients Treated with 0.9mg/kg IV rt-PA or 0.25mg/kg IV TNK within 3 hours of stroke onset or time last known well Age ≥ 18 NIHSS score ≥ 6 prior to IV thrombolysis Able to receive assigned study drug within 60 minutes but no later than 75 minutes of initiation of IV thrombolysis

Exclusion Criteria:

Known allergy or hypersensitivity to argatroban or eptifibatide Previous stroke in the past 90 days Previous intracranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arterial venous malformation Clinical presentation suggested a subarachnoid hemorrhage, even if initial CT scan was normal Any surgery, or biopsy of parenchymal organ in the past 30 days Trauma with internal injuries or ulcerative wounds in the past 30 days Severe head trauma in the past 90 days Systolic blood pressure persistently >180mmHg post-IV thrombolysis despite antihypertensive intervention Diastolic blood pressure persistently >105mmHg post-IV thrombolysis despite antihypertensive intervention Serious systemic hemorrhage in the past 30 days Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR >1.5 Positive urine or serum pregnancy test for women of child bearing potential Glucose <50 or >400 mg/dl Platelets <100,000/mm3 Hematocrit <25 % Elevated pre-thrombolysis PTT above laboratory upper limit of normal Creatinine > 4 mg/dl Ongoing renal dialysis, regardless of creatinine Received Low Molecular Weight heparins (such as Dalteparin, Enoxaparin, Tinzaparin) in full dose within the previous 24 hours Abnormal PTT within 48 hours prior to randomization after receiving heparin or a direct thrombin inhibitor (such as bivalirudin, argatroban, dabigatran or lepirudin) Received Factor Xa inhibitors (such as Fondaparinaux, apixaban or rivaroxaban) within the past 48 hours Received glycoprotein IIb/IIIa inhibitors within the past 14 days Pre-existing neurological or psychiatric disease which confounded the neurological or functional evaluations e.g., baseline modified Rankin score >3 Other serious, advanced, or terminal illness or any other condition that the investigator felt would pose a significant hazard to the patient if rt-PA, TNK, eptifibatide or argatroban therapy was initiated a. Example: known cirrhosis or clinically significant hepatic disease Current participation in another research drug treatment or interventional device trial - Subjects could not start another experimental agent until after 90 days Informed consent from the patient or the legally authorized representative was not or could not be obtained High density lesion consistent with hemorrhage of any degree Large (more than 1/3 of the middle cerebral artery) regions of clear hypodensity on the baseline CT Scan. Sulcal effacement and/or loss of grey-white differentiation alone are not contraindications for treatment

Interventions: Argatroban, Eptifibatide, Placebo, Argatroban, Eptifibatide, Placebo

Conditions: Acute Ischemic Stroke

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MT2019-06: A Phase 3 Study Evaluating Gene Therapy by Transplantation of Autologous CD34+ Stem Cells Transduced Ex Vivo with the LentiGlobin BB305 Lentiviral Vector in Subjects with Sickle Cell Disease.

Description:

Evaluate the efficacy of treatment with bb1111 (also known as LentiGlobin BB305 Drug Product for Sickle Cell Disease) in subjects with sickle cell disease (SCD).

Principal Investigator: Ashish Gupta

Sex: All

Age: 2 Years to 50 Years old

Phase: Phase 3

This study is NOT accepting healthy volunteers

System ID: STUDY00006923

IRB Number: STUDY00006923

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Inclusion Criteria:

Have a diagnosis of SCD, with either βS/βS, βS/β0, or βS/β+ genotype. Be ≥2 and ≤50 years of age at time of consent. Weigh a minimum of 6 kg. Have a Karnofsky performance status of ≥60 (≥16 years of age) or a Lansky performance status of ≥60 (<16 years of age). Be treated and followed for at least the past 24 months prior to Informed Consent in medical center(s) that maintained detailed records on sickle cell disease history. In the setting of appropriate supportive care measures (e.g., pain management plan), have experienced at least 4 protocol-defined VOEs in the 24 months prior to informed consent. Have either experienced HU failure at any point in the past or must have intolerance to HU (intolerance is defined as the patient being unable to continue to take HU per PI judgment). Female and male subjects of childbearing potential agree to use 1 method of highly effective contraception from Screening to at least 6 months after drug product infusion. Provision of written informed consent for this study by subject, or as applicable, subject's parent(s)/legal guardian(s).

Exclusion Criteria:

Subjects for whom allogeneic hematopoietic stem cell transplantation (allo-HSCT) is medically appropriate per PI judgment and a willing, human leukocyte antigen (HLA)-matched related hematopoietic stem cell donor is available. Severe cerebral vasculopathy, defined by any history of overt ischemic or hemorrhagic stroke, a history of abnormal transcranial Doppler (TCD) or TCD imaging (TCDI) for subjects ≤ 16 years of age (e.g. TCD velocity >200 cm/sec) requiring ongoing chronic transfusions, a Screening TCD or TCDI velocity > 200 cm/sec (central read), a Screening MRA showing > 50% stenosis or occlusion in the circle of Willis (central read), or a Screening MRA showing the presence of Moyamoya (central read). Positive for presence of human immunodeficiency virus type 1 or 2 (HIV-1 or HIV-2), hepatitis B, hepatitis C, human T-lymphotropic virus-1 (HTLV-1), active syphilis. Clinically significant, active bacterial, viral, fungal, or parasitic infection Advanced liver disease, such as clear evidence of liver cirrhosis, active hepatitis or significant fibrosis (based on MRI or liver biopsy) liver iron concentration ≥15 mg/g unless liver biopsy shows no evidence of cirrhosis, active hepatitis or significant fibrosis Inadequate bone marrow function, as defined by an absolute neutrophil count of <1×10^9/L (<0.5×10^9/L for subjects on hydroxyurea treatment) or a platelet count <100×10^9/L. Any contraindications to the use of plerixafor during the mobilization of hematopoietic stem cells and any contraindications to the use of busulfan and any other medicinal products required during the myeloablative conditioning, including hypersensitivity to the active substances or to any of the excipients. Patients needing therapeutic anticoagulation treatment during the period of conditioning through platelet engraftment Unable to receive pRBC transfusion. Prior receipt of an allogeneic transplant. Prior receipt of gene therapy. Any prior or current malignancy or immunodeficiency disorder, except previously treated, non-life threatening, cured tumors such as squamous cell carcinoma of the skin. Immediate family member with a known or suspected Familial Cancer Syndrome. Female subject is breastfeeding, pregnant or will attempt to become pregnant from Screening to at least 6 months after drug product infusion. Any other condition that would render the subject ineligible for HSCT. Participation in another clinical study with an investigational drug within 30 days of screening. Presence of a chromosomal abnormality or genetic mutation that may put the subject at an increased risk of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) per Investigator's judgment. Presence of genetic mutations that result in the inactivation of 2 or more α-globin genes

Interventions: bb1111, bb1111

Conditions: Sickle Cell Disease

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MT2021-03: A Multicenter Randomized Controlled Trial of Best Available Therapy versus Autologous Hematopoietic Stem Cell Transplant for Treatment-Resistant Relapsing Multiple Sclerosis (BEAT-MS)

Principal Investigator: Adam Carpenter

Sex: All

Age: 18 Years to 55 Years old

Phase: Phase 3

This study is NOT accepting healthy volunteers

System ID: STUDY00007288

IRB Number: STUDY00007288

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Inclusion Criteria:

Participant(s) must meet all of the following criteria to be eligible for this study: Diagnosis of Multiple Sclerosis (MS) according to the 2017 McDonald Criteria (Kurtzke) Expanded Disability Status Scale (EDSS) ≤ 6.0 at the time of randomization (Day 0) T2 abnormalities on brain Magnetic Resonance Imaging (MRI) that fulfill the 2017 McDonald MRI criteria for dissemination in space --A detailed MRI report or MRI images must be available for review by the site neurology investigator. Highly active treatment-resistant relapsing MS, defined as ≥ 2 episodes of disease activity in the 36 months prior to the screening visit (Visit -2). The two disease activity episodes will be a clinical MS relapse or MRI evidence of MS disease activity and must meet all the criteria as described below: At least one episode of disease activity must occur following ≥ 1 month of treatment with an oral DMT approved by the FDA or MHRA for the treatment of relapsing MS, or a monoclonal antibody, specifically: dimethyl fumarate (Tecfidera®), diroximel fumarate, teriflunomide (Aubagio®), cladribine (Mavenclad®), daclizumab (Zinbryta®), siponimod (Mayzent®), ozanimod, fingolimod (Gilenya®), rituximab (Rituxan®), ocrelizumab (Ocrevus®), natalizumab (Tysabri®), alemtuzumab (Campath®, Lemtrada®), or ofatumumab (Arzerra®), and At least one episode of disease activity must have occurred within the 12 months prior to the screening visit (Visit -2), and At least one episode of disease activity must be a clinical MS relapse (see item c.i. below). The other episode(s) must occur at least one month before or after the onset of the clinical MS relapse, and must be either another clinical MS relapse or MRI evidence of disease activity (see item d.ii. below): i. Clinical MS relapse must be confirmed by a neurologist's assessment and documented contemporaneously in the medical record. If the clinical MS relapse is not documented in the medical record, it must be approved by the study adjudication committee, and ii. MRI evidence of disease activity must include ≥ 2 unique active lesions on a brain or spinal cord MRI. A detailed MRI report or MRI images must be available for review by the site neurology investigator. A unique active lesion is defined as either of the following: A gadolinium-enhancing lesion, or A new non-enhancing T2 lesion compared to a reference scan obtained not more than 24 months prior to the screening visit (Visit -2). Candidacy for treatment with at least one of the following high efficacy DMTs: Cladribine, natalizumab, alemtuzumab, ocrelizumab, rituximab, and ofatumumab (after approval by the FDA for relapsing MS). Candidacy for treatment for each DMT is defined as meeting all of the following: No prior disease activity with the candidate DMT, and No contraindication to the candidate DMT, and No treatment with the candidate DMT in the 12 months prior to screening. Completion of SARS-CoV-2 vaccination series ≥ 14 days prior to randomization (Day 0). Positive for VZV antibodies, or completion of at least one dose of the varicella zoster glycoprotein E (gE) Shingrix vaccine at least 4 weeks prior to randomization (Day 0). Insurance or public funding approval for MS treatment with at least one candidate DMT, and Ability to comply with study procedures and provide informed consent, in the opinion of the investigator.

Exclusion Criteria:

Subject(s) who meet any of the following criteria will not be eligible for this study: Diagnosis of primary progressive Multiple Sclerosis (MS) according to the 2017 McDonald criteria History of neuromyelitis optica or anti-myelin oligodendrocyte glycoprotein (anti-MOG) antibodies associated encephalomyelitis Prior treatment with an investigational agent within 3 months or 5 half-lives, whichever is longer. Agents authorized by the FDA or MHRA for prevention or treatment of SARS-CoV-2 are not considered investigational. Either of the following within one month prior to randomization (Day 0): Onset of acute MS relapse, or Treatment with intravenous methylprednisolone 1000 mg/day for 3 days or equivalent. Initiation of natalizumab, alemtuzumab, ocrelizumab, or rituximab between screening visit (Visit -2) and randomization (Day 0) Brain MRI or Cerebrospinal fluid (CSF) examination indicating a diagnosis of progressive multifocal leukoencephalopathy (PML) History of cytopenia consistent with the diagnosis of myelodysplastic syndrome (MDS) Presence of unexplained cytopenia, polycythemia, thrombocythemia or leukocytosis History of sickle cell anemia or other hemoglobinopathy Evidence of past or current hepatitis B or hepatitis C infection, including treated hepatitis B or hepatitis C -Note: Hepatitis B surface antibody following hepatitis B immunization is not considered to be evidence of past infection. Presence or history of mild to severe cirrhosis Hepatic disease with the presence of either of the following: Total bilirubin ≥ 1.5 times the upper limit of normal (ULN) or total bilirubin
• 0 times the ULN in the presence of Gilbert's syndrome, or Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≥ 2.0 times the ULN. Positive SARS-CoV-2 PCR test, or alternative nucleic acid amplification test (NAAT) per institutional standards, within 14 days prior to randomization (Day 0). Evidence of HIV infection Positive QuantiFERON - TB Gold, TB Gold Plus, or T-SPOT®.TB test results (e.g., blood test results. Purified Protein Derivative (PPD) tuberculin test may be substituted for QuantiFERON - TB Gold, TB Gold Plus, or T-SPOT®.TB test results. Active viral, bacterial, endoparasitic, or opportunistic infections Active invasive fungal infection Hospitalization for treatment of infections or parenteral (IV or IM) antibacterials, antivirals, antifungals, or antiparasitic agents within the 30 days prior to randomization (Day 0) unless clearance is obtained from an Infectious Disease specialist Receipt of live or live-attenuated vaccines within 6 weeks of randomization (Day 0) Presence or history of clinically significant cardiac disease including: Arrhythmia requiring treatment with any antiarrhythmia therapy, with the exception of low dose beta blocker for intermittent premature ventricular contractions Coronary artery disease with a documented diagnosis of either: Chronic exertional angina, or Signs or symptoms of congestive heart failure. Evidence of heart valve disease, including any of the following: Moderate to severe valve stenosis or insufficiency, Symptomatic mitral valve prolapse, or Presence of prosthetic mitral or aortic valve. Left ventricular ejection fraction (LVEF) < 50% Impaired renal function defined as Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula Forced expiratory volume in one second (FEV1) <70% predicted (no bronchodilator) Diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected for Hgb) < 70% predicted Poorly controlled diabetes mellitus, defined as HbA1c >8% History of malignancy, with the exception of adequately treated localized basal cell or squamous skin cancer, or carcinoma in situ of the cervix. -Note:Malignancies for which the participant is judged to be cured prior to randomization (Day 0) will be considered on an individual basis by the study adjudication committee. Presence or history of any moderate to severe rheumatologic autoimmune disease requiring treatment, including but not limited to the following: systemic lupus erythematous systemic sclerosis rheumatoid arthritis Sjögren's syndrome polymyositis dermatomyositis mixed connective tissue disease polymyalgia rheumatica polychondritis sarcoidosis vasculitis syndromes, or unspecified collagen vascular disease. Presence of active peptic ulcer disease, defined as endoscopic or radiologic diagnosis of gastric or duodenal ulcer Prior history of AHSCT Prior history of solid organ transplantation Positive pregnancy test or breast-feeding Inability or unwillingness to use effective means of birth control Failure to willingly accept or comprehend irreversible sterility as a side effect of therapy Psychiatric illness, mental deficiency, or cognitive dysfunction severe enough to interfere with compliance or informed consent History of hypersensitivity to mouse, rabbit, or Escherichia coli-derived proteins Any metallic material or electronic device in the body, or condition that precludes the participant from undergoing MRI with gadolinium administration Presence or history of ischemic cerebrovascular disorders, including but not limited to transient ischemic attack, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism, or cerebral hemorrhage Presence or history of other neurological disorders, including but not limited to: central nervous system (CNS) or spinal cord tumor metabolic or infectious cause of myelopathy genetically-inherited progressive CNS disorder CNS sarcoidosis, or systemic autoimmune disorders potentially causing progressive neurologic disease or affecting ability to perform the study assessments. Presence of any medical comorbidity that the investigator determines will significantly increase the risk of treatment mortality, or Presence of any other concomitant medical condition that the investigator deems incompatible with trial participation.

Interventions: Autologous Hematopoietic Stem Cell Transplantation, Best Available Therapy (BAT), Autologous Hematopoietic Stem Cell Transplantation, Best Available Therapy (BAT)

Conditions: Rare Diseases

Keywords: Clinics and Surgery Center (CSC)

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Study in Parkinson Disease of Exercise Phase 3 Clinical Trial: SPARX3 (SPARX3)

Description:

This study is a Phase 3 multi-site, randomized, evaluator-masked, study of endurance treadmill exercise on changes in the motor severity of Parkinson's disease after 12 months of exercise.

Principal Investigator: Colum MacKinnon

Sex: All

Age: 40 Years to 80 Years old

Phase: N/A

This study is NOT accepting healthy volunteers

System ID: STUDY00012549

IRB Number: STUDY00012549

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Inclusion Criteria:

A diagnosis of idiopathic Parkinson Disease based on the modified * United Kingdom (UK) PD brain bank criteria and which are consistent with recent criteria proposed for clinically established early established Parkinson's disease that no longer exclude individuals with a family history of Parkinson's disease. Hoehn and Yahr stages less than 3 Disease duration: less than 3 years since disease diagnosis Age 40-80 years Positive DaTscan™ SPECT by quantitative readout for idiopathic Parkinson disease.

Exclusion Criteria:

Currently being treated with PD medications such as levodopa or dopamine receptor agonists, monoamine oxidase-B (MAO-B) inhibitors, amantadine, or anticholinergics. Expected to require treatment with medication for PD in the first 6 months of the study. Use of any PD medication 60 days prior to the baseline visit including but not limited to levodopa, direct dopamine agonists, amantadine, Rasagiline (Azilect), Selegiline (Eldepryl), Artane (trihexyphenidyl). Duration of previous use of medications for PD exceeds 60 days. Use of neuroleptics/dopamine receptor blockers for more than 30 days in the year prior to baseline visit, or any use within 30 days of baseline visit Presence of known cardiovascular, metabolic, or renal disease or individuals with major signs or symptoms suggestive of cardiovascular, metabolic, or renal disease without medical clearance to participate in the exercise program. Uncontrolled hypertension (resting blood pressure >150/90 mmHg) Individuals with orthostatic hypotension and standing systolic BP below 100 will be excluded. Orthostatic hypotension (OH) is a reduction of systolic blood pressure of at least 20 mm Hg or diastolic blood pressure of at least 10 mm Hg within 3 minutes of standing. Hypo- or hyperthyroidism (TSH <0.5 or >5.0 mU/L), abnormal liver function (AST or ALT more than 2 times the upper limit of normal), abnormal renal function (estimated glomerular filtration rate (eGFR) using the MDRD4 equation or the CKD-EPI equation <45mL/min/1.73m2 ). Complete Blood Count (CBC) out of range and physician's judgment that abnormal value is clinically significant. Recent use of psychotropic medications (e.g., anxiolytics, hypnotics, benzodiazepines, antidepressants) where dosage has not been stable for 28 days prior to screening. Serious illness (requiring systemic treatment and/or hospitalization) within the last 4 weeks. Any other clinically significant medical condition, psychiatric condition, drug or alcohol abuse, assessment or laboratory abnormality that would, in the judgment of the investigator, interfere with the subject's ability to participate in the study. Montreal Cognitive Assessment (MoCA) score of <24. Beck Depression Inventory II (BDI) score > 28, indicating severe depression that precludes ability to exercise. Any subject with such a score will be referred to a PCP or physician for further evaluation and management of depression. Individuals with a BDI-II score of 17-28 will be excluded if any of the following conditions are met: (1) individual is suicidal, (2) is in need of depression treatment modification currently or (3) depressive symptoms likely to interfere with adherence to study protocol. Any subject with such a score will be referred to a PCP or physician for further evaluation and management of depression. Individuals who have been exercising at greater than moderate intensity for 120 minutes or more per week consistently over the last 6 months will be excluded. Greater than moderate intensity is defined as a range greater than 60-65% HRmax. These individuals are excluded since their exercise activities are greater than the activities they would experience if they were assigned to the 60-65% treatment group. As such, they would be expected to lose fitness. Use of the following within 90 days prior to the DAT neuroimaging screening evaluation: modafinil, armodafinil, metoclopramide, alpha-methyldopa, methylphenidate, reserpine, any amphetamine or amphetamine derivative, or use of buproprion within 8 days prior to the DAT neuroimaging screening evaluation. These can compromise DaTscan™ SPECT. Known allergy to iodinated products. Known hypersensitivity to DaTscan™ SPECT (either to the active substance of 123I-ioflupane or any of the excipients. (For women only) Actively breast-feeding an infant, and/or pregnant, or plan to become pregnant in the next 12 months. Other disorders, injuries, diseases, or conditions that might interfere with ability to perform endurance exercises (e.g. history of stroke, respiratory problems, traumatic brain injury, orthopedic injury, or neuromuscular disease).

Interventions: Treadmill walking, Treadmill walking

Conditions: Parkinson Disease

Keywords: Clinics and Surgery Center (CSC)

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Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors
for Stroke Prevention and Recovery (ASPIRE)

Principal Investigator: Oladi Bentho

Sex: All

Age: 18 Years to old

Phase: Phase 3

This study is NOT accepting healthy volunteers

System ID: STUDY00008045

IRB Number: STUDY00008045

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Interventions: Apixaban, Aspirin, Apixaban, Aspirin

Conditions: Intracerebral Hemorrhage, Atrial Fibrillation

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COG AALL1732: A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

Description:

This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first two phases of therapy: Induction and Consolidation. This part will collect information on the leukemia, as well as the effects of the initial treatment, in order to classify patients into post-consolidation treatment groups. On the second part of this study, patients will receive the remainder of the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance II, maintenance), with some patients randomized to receive inotuzumab. Other aims of this study include investigating whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for an additional year compared to girls, as well as to evaluate the best ways to help patients adhere to oral chemotherapy regimens. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.

Principal Investigator: Peter Gordon

Sex: All

Age: 1 Year to 25 Years old

Phase: Phase 3

This study is NOT accepting healthy volunteers

System ID: STUDY00008473

IRB Number: STUDY00008473

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Inclusion Criteria:

B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to eligibility studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 22 business days after enrollment for MPAL patients. If not performed within this time frame, patients will be taken off protocol. APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732. Patients must be > 365 days and < 25 years of age White blood cell count (WBC) criteria for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy): Age 1-9.99 years: WBC >= 50,000/uL Age 10-24.99 years: Any WBC Age 1-9.99 years: WBC < 50,000/uL with: Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment. White blood cell count (WBC) criteria for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy): Age 1-24.99 years: any WBC. Patient has newly diagnosed B-ALL or MPAL (by World Health Organization [WHO] 2016 criteria) with >= 25% blasts on a bone marrow (BM) aspirate; OR If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM biopsy; OR A complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells if a bone marrow aspirate or biopsy cannot be performed. Patient has newly diagnosed B-LLy Murphy stages III or IV. Patient has newly diagnosed B-LLy Murphy stages I or II with steroid pretreatment. Note: For B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL. For tissue processed by other means (i.e., paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted. All patients and/or their parents or legal guardians must sign a written informed consent. All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met.

Exclusion Criteria:

Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group). With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732. Patients who have received > 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy. Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells. Patients with acute undifferentiated leukemia (AUL) are not eligible. For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, the following additional exclusion criteria apply: T-lymphoblastic lymphoma. Morphologically unclassifiable lymphoma. Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma. Patients with known Charcot-Marie-Tooth disease. Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype. Patients requiring radiation at diagnosis. Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential. Lactating women who plan to breastfeed their infants while on study and for 2 months after the last dose of inotuzumab ozogamicin. Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of study participation. For those patients randomized to inotuzumab ozogamicin, there is a minimum of 8 months after the last dose of inotuzumab ozogamicin for females and 5 months after the last dose of inotuzumab ozogamicin for males.

Interventions: Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Bone Scan, Calaspargase Pegol-mknl, Computed Tomography, Cyclophosphamide, Cytarabine, Daunorubicin Hydrochloride, Dexamethasone, Doxorubicin Hydrochloride, Inotuzumab Ozogamicin, Leucovorin Calcium, Magnetic Resonance Imaging, Mercaptopurine, Methotrexate, Pegaspargase, Positron Emission Tomography, Prednisolone, Questionnaire Administration, Radiation Therapy, Radiation Therapy, Thioguanine, Vincristine Sulfate, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Bone Scan, Calaspargase Pegol-mknl, Computed Tomography, Cyclophosphamide, Cytarabine, Daunorubicin Hydrochloride, Dexamethasone, Doxorubicin Hydrochloride, Inotuzumab Ozogamicin, Leucovorin Calcium, Magnetic Resonance Imaging, Mercaptopurine, Methotrexate, Pegaspargase, Positron Emission Tomography, Prednisolone, Questionnaire Administration, Radiation Therapy, Radiation Therapy, Thioguanine, Vincristine Sulfate

Conditions: B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma, Central Nervous System Leukemia, Mixed Phenotype Acute Leukemia, Testicular Leukemia

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COG AGCT1532 - A Randomized Phase 3 Trial of Accelerated versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-risk Metastatic Germ Cell Tumors (P3BEP)

Description:

This trial is an open label, randomized, stratified 2-arm Australian-led multicenter phase 3 clinical trial undertaken in two stages. Participants (age >= 11 years and <= 45 years) with intermediate and poor-risk metastatic germ cell tumors will be randomized into either a “standard BEP” group or “accelerated BEP” group. Participants will be assigned to the two treatment arms in a 1:1 ratio and evaluated weekly, and then for 5 years after completing the study to assess the long-term effects of the chemotherapy. Bleomycin, Etoposide, Cisplatin (BEP) administered 3-weekly x 4 remains standard 1st line chemotherapy for intermediate- and poor-risk metastatic germ cell tumours (GCTs). BEP is accelerated by cycling Cisplatin and etoposide 2-weekly instead of 3-weekly. The aim of this study is to determine if accelerated BEP is superior to standard BEP as first-line chemotherapy for intermediate and poor risk metastatic GCTs.

Principal Investigator: Emily Greengard

Sex: All

Age: 11 Years to 45 Years old

Phase: Phase III

This study is NOT accepting healthy volunteers

System ID: STUDY00004158

IRB Number: STUDY00004158

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Inclusion Criteria:

Age ≥ 11 years and ≤ 45 years on the date of randomisation Histologically or cytologically confirmed germ cell tumour (non-seminoma or seminoma); or Exceptionally raised tumour markers (AFP ≥ 1000ng/mL and/or HCG ≥ 5000 IU/L) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with GCT, high tumour burden, and a need to start therapy urgently Primary arising in testis, ovary, retro-peritoneum, or mediastinum Metastatic disease or non-testicular primary Intermediate or poor prognosis as defined by IGCCC classification3 (modified with different LDH criteria for intermediate risk non-seminoma, and inclusion of ovarian primaries). (See protocol for more information). Adequate bone marrow function with ANC ≥1.0 x 10^9/L, Platelet count ≥100 x 10^9/L Adequate liver function where bilirubin must be ≤1.5 x ULN, except participants with Gilbert's Syndrome where bilirubin must be ≤2.0 x ULN; ALT and AST must be ≤2.5 x ULN, except if the elevations are due to hepatic metastases, in which case ALT and AST must be ≤ 5 x ULN Adequate renal function with estimated creatinine clearance of ≥60 ml/min according to the Cockcroft-Gault formula, unless calculated to be < 60 ml/min or borderline in which case GFR should be formally measured, eg. with EDTA scan ECOG Performance Status of 0, 1, 2, or 3 Study treatment both planned and able to start within 14 days of randomisation. Willing and able to comply with all study requirements, including treatment, timing and nature of required assessments Able to provide signed, written informed consent

Exclusion Criteria:

Other primary malignancy (EXCEPT adequately treated non-melanomatous carcinoma of the skin, germ cell tumour, or other malignancy treated at least 5 years previously with no evidence of recurrence) Previous chemotherapy or radiotherapy, except if patient has pure seminoma relapsing after adjuvant radiotherapy or adjuvant chemotherapy with 1-2 doses of single agent carboplatin or if patient has non-seminoma and poor prognosis by IGCCC criteria in the rare case where low-dose induction chemotherapy is given prior to registration because patient is not fit enough to receive protocol chemotherapy (eg. organ failure, vena cava obstruction, overwhelming burden of disease). In these instances acceptable regimens include cisplatin 20 mg/m^2 days 1-2 and etoposide 100 mg/m^2 days 1-2; carboplatin AUC 3 days 1-2 and etoposide 100 mg/m^2 days 1-2; or baby-BOP. Patients must meet all other inclusion and exclusion criteria at the time of registration. Additionally participants who need to start therapy urgently prior to completing study-specific baseline investigations may commence study chemotherapy prior to registration and randomisation. Such patients must be discussed with the coordinating centre prior to registration, and must be registered within 10 days of commencing study chemotherapy. Significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin Significant co-morbid respiratory disease that contraindicates the use of bleomycin Peripheral neuropathy ≥ grade 2 or clinically significant sensorineural hearing loss or tinnitus Concurrent illness, including severe infection that may jeopardize the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety Inadequate contraception. Men must use 2 effective methods of contraception, including use of a condom, during chemotherapy and for a year after completing chemotherapy. Known allergy or hypersensitivity to any of the study drugs Presence of any psychological, familial, sociological or geographical condition that in the opinion of the investigator would hamper compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse The above inclusion and exclusion criteria will apply to stage 1 (n=150) and stage 2 (n=500 including stage 1) of the study. All sites will participate in both stages of the study with the exception of the Children's Oncology Group who will be participate in stage 1 only.

Interventions: Bleomycin (active name: Bleomycin Sulfate), Etoposide, Cisplatin, Pegylated G-CSF (Pegfilgrastim), Filgrastim, Bleomycin (active name: Bleomycin Sulfate), Etoposide, Cisplatin, Pegylated G-CSF (Pegfilgrastim), Filgrastim

Conditions: Germ Cell Tumor

Keywords: Germ Cell, Intermediate and poor-risk metastatic germ cell tumours

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MT2019-37: A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III Trial of Alpha 1 - Antitrypsin (AAT) Combined with Corticosteroids vs Corticosteroids Alone for the Treatment of High Risk Acute Graft-versus-Host Disease (GVHD) Following Allogeneic Hematopoietic Stem Cell Transplant (CTN 1705)

Description:

This study is a phase III, multicenter, double-blinded, randomized, placebo-controlled trial designed to compare AAT and corticosteroids (CS) to placebo and CS as first line therapy for patients with high-risk acute GVHD. The primary objective of this trial is to compare the rate of complete response (CR) and partial response (PR) on Day 28 post-randomization between AAT and CS versus placebo to match (PTM) and CS in patients with high-risk acute GVHD.

Principal Investigator: Najla El Jurdi

Sex: All

Age: 12 Years to old

Phase: Phase 3

This study is NOT accepting healthy volunteers

System ID: STUDY00007934

IRB Number: STUDY00007934

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Interventions: Alpha-1 antitrypsin (AAT), Placebo, Alpha-1 antitrypsin (AAT), Placebo

Conditions: Graft Versus Host Disease (GVHD)

Keywords: Clinics and Surgery Center (CSC)

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COG ANBL1232 - Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients with Non-High- Risk Neuroblastoma

Description:

This phase III trial studies how well response and biology-based risk factor-guided therapy works in treating younger patients with non-high risk neuroblastoma. Sometimes a tumor may not need treatment until it progresses. In this case, observation may be sufficient. Measuring biomarkers in tumor cells may help plan when effective treatment is necessary and what the best treatment is. Response and biology-based risk factor-guided therapy may be effective in treating patients with non-high risk neuroblastoma and may help to avoid some of the risks and side effects related to standard treatment.

Principal Investigator: Emily Greengard

Sex: All

Age: to 18 Months old

Phase: Phase 3

This study is NOT accepting healthy volunteers

System ID: 1410M54605

IRB Number: 1410M54605

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Inclusion Criteria:

Patients must be: < 12 months (< 365 days) of age at diagnosis with INRG stage L1; or < 18 months (< 547 days) of age at diagnosis with INRG stage L2 or stage Ms neuroblastoma/ganglioneuroblastoma Enrollment on ANBL00B1 or APEC14B1 is required for all newly diagnosed patients Patients must have newly diagnosed v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) non-amplified neuroblastoma (International Classification of Diseases for Oncology [ICD-O] morphology 9500/3) or MYCN non-amplified ganglioneuroblastoma verified by histology Patients must meet the specified criteria for one of the treatment groups defined below; genomic features include MYCN gene amplification, segmental chromosome aberrations (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q) and deoxyribonucleic acid (DNA) index "Favorable" genomic features are defined by one or more whole-chromosome gains or hyperdiploid tumor (DNA index > 1) in the absence of segmental chromosome aberrations as defined above "Unfavorable" genomic features are defined by the presence of any segmental chromosome aberration (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q) or diploid tumor (DNA index = 1); this includes copy neutral loss of heterozygosity (LOH) Only patients with MYCN non-amplified tumors are eligible for this study Group A: patients < 12 months (< 365 days) of age with newly diagnosed INRG stage L1 neuroblastoma/ganglioneuroblastoma who meet the following criteria: Greatest tumor diameter < 5 cm of adrenal or non-adrenal origin Patients with non-adrenal primaries are eligible, but must have positive uptake on metaiodobenzylguanidine (MIBG) scan or elevated catecholamine metabolites (urine or serum) to support the diagnosis of neuroblastoma No prior tumor resection or biopsy Group A will be further split into two subsets, which are mutually exclusive, for statistical purposes Group A1: > 6 months and < 12 months of age with an adrenal primary tumor < 5 cm in greatest diameter OR Patients less than 6 months of age with an adrenal primary tumor > 3.1 and < 5 cm in greatest diameter OR < 12 months of age with a non-adrenal primary site < 5 cm in greatest diameter Group A2: =< 6 months of age with an adrenal primary site and tumor =< 3.1 cm in greatest diameter. Group B: patients < 18 months (< 547 days) of age with newly diagnosed INRG stage L2 neuroblastoma/ganglioneuroblastoma who meet the following criteria: No life threatening symptoms or no impending neurologic or other organ function compromise (e.g. epidural or intraspinal tumors with existing or impending neurologic impairment, periorbital or calvarial-based lesions with existing or impending cranial nerve impairment, anatomic or mechanical compromise of critical organ function by tumor [abdominal compartment syndrome, urinary obstruction, etc.]); horner syndrome is not considered neurologic compromise No prior tumor resection, tumor biopsy ONLY Only patients with both favorable histology and favorable genomic features will remain on study as part of Group B; the institution will be notified of histologic and genomic results within 3 weeks of specimen submission on ANBL00B1 or APEC14B1 Group C: patients < 18 months (< 547 days) of age with newly diagnosed INRG stage Ms neuroblastoma/ganglioneuroblastoma No prior radiotherapy or chemotherapy, with the exception of dexamethasone, which is allowed All patients and/or their parents or legal guardians must sign a written informed consent All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria:

Patients with MYCN amplified tumors are not eligible Group B and C patients who do not enroll on ANBL1232 within 4 weeks of definitive diagnostic procedure Group A and C patients, not required to undergo tumor biopsy, who do not enroll on ANBL1232 within 4 weeks of confirmatory imaging study

Interventions: Carboplatin, Clinical Observation, Cyclophosphamide, Doxorubicin Hydrochloride, Etoposide, Laboratory Biomarker Analysis, Pharmacological Study, Carboplatin, Clinical Observation, Cyclophosphamide, Doxorubicin Hydrochloride, Etoposide, Laboratory Biomarker Analysis, Pharmacological Study

Conditions: Ganglioneuroblastoma, Localized Resectable Neuroblastoma, Localized Unresectable Neuroblastoma, Neuroblastoma

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MT2017-28 The Head Start 4 Protocol - Newly Diagnosed Children (less than 10 years old) with Medulloblastoma and Other Central Nervous System Embryonal Tumors: Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation with Either Single Cycle (Low Risk Patients) or Randomization (High Risk Patients) to Either Single-Cycle or to Three Tandem Cycles of Marrow-Ablative Chemotherapy with Autologous Hematopoietic Progenitor Cell Rescue Added Title: Neuroanatomical, Cognitive and Family Aspects to Recovery from a Brain Tumor

Principal Investigator: Christopher Moertel, MD

Sex: All

Age: to 10 Years old

Phase: Phase 4

This study is NOT accepting healthy volunteers

System ID: STUDY00000427

IRB Number: STUDY00000427

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Inclusion Criteria:

Patients 10 years of age at the time of definitive confirmatory eligible histologic or cytologic diagnosis of eligible CNS tumor (brain or spinal cord) Patients may not have received irradiation or chemotherapy (except corticosteroids) Have histologically proven diagnosis of medulloblastoma or CNS embryonal tumors of the brain or spinal cord Medulloblastoma Posterior fossa classic, desmoplastic or extensive nodular or anaplastic/large cell medulloblastoma with appropriate and sufficient tumor material (FFPE or snap frozen) for proposed assays: all stages, age less than 6 years at diagnosis Posterior fossa classic or anaplastic/large cell medulloblastoma with sufficient tumor material (FFPE or snap frozen) for proposed assays: clinically high-stage (neuraxis or extra-neural dissemination, M1-4), age greater than 6 years to less than 10 years at diagnosis Posterior fossa medulloblastoma, those 6 years of age and above at diagnosis, will only be eligible if they have evidence of neuraxis or extraneural dissemination. Patients 6 years of age and above with low-stage (standard-risk, M0) medulloblastoma will NOT be eligible for this study, irrespective of molecular subgroup and extend of local resection CNS Embryonal Tumors:
• Pineoblastoma, CNS neuroblastoma, CNS ganglioneuroblastoma, embryonal tumor with multi-layered rosettes (ETMR, including embryonal tumor with abundant neuropil and true rosettes (ETANTR), ependymoblastoma and ETMR not otherwise specified), medulloepithelioma, CNS embryonal tumor with rhabdoid features (INI1 intact) and CNS embryonal tumor, not otherwise specified. Must commence Induction chemotherapy within 28 days of the most recent definitive surgical procedure and within 21 days of the most recent neuro-imaging studies (MRI of brain, performed with and without gadolinium contrast, and MRI of total spine, performed with gadolinium contrast) and lumbar CSF cytological examination Patients must have adequate organ functions at the time of registration: Liver: bilirubin less than 1.5 mg/dL (except for patients with Gilbert's Syndrome of indirect hyperbilirubinemia) and transaminases [SGPT or ALT, and SGOT or AST] less than 2.5 (two and a half) times the upper limits of institutional normal. Renal: Creatinine clearance and/or glomerular filtration rate (GFR) greater than or equal to 60 mL/min/1.73m² within 21 days of protocol therapy. Bone Marrow Function: Peripheral absolute phagocyte count (APC) > 1000/ µL. APC = numbers of banded neutrophils + segmented neutrophils + metamyelocytes + monocytes + eosinophils Please note, if institution reports differential as a percentage, then APC = [percentage of banded neutrophils + segmented neutrophils+ metamyelocytes+monocytes+eosinophils] x total white cell count. Platelet Count > 100,000/µL (transfusion independent) Hemoglobin > 8 gm/dL (may have received RBC transfusions).

Exclusion Criteria:

Patients older than 10 years of age at time of diagnosis Following diagnoses are not eligible for study enrollment: CNS atypical teratoid/rhabdoid tumor (AT/RT); all ependymomas including anaplastic ependymomas of the brain or spinal cord; all choroid plexus carcinomas; all high-grade glial and glio-neuronal tumors; all primary CNS germ cell tumors; all primary CNS sarcomas; all primary or metastatic CNS lymphomas and solid leukemic lesions (i.e., chloromas, granulocytic sarcomas). Patients with unbiopsied diffuse intrinsic pontine tumors will NOT be eligible for this study.

Interventions: Induction, Single Cycle Intensive Chemotherapy, Tandem 3 Cycle Intensive Chemotherapy, Induction, Single Cycle Intensive Chemotherapy, Tandem 3 Cycle Intensive Chemotherapy

Conditions: Medulloblastoma, Central Nervous System Embryonal Tumors

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A Phase 3, Open-label, Randomized Study of Nivolumab Combined with Ipilimumab, or with Standard of Care Chemotherapy, versus Standard of Care Chemotherapy in participants with Previously Untreated Unresectable or Metastatic Urothelial Cancer (CheckMate901)

Description:

This is a randomized, open-label, Phase 3 study comparing combination therapy of nivolumab plus ipilimumab administered every 3 weeks for up to 4 doses, followed by nivolumab monotherapy administered every 4 weeks, versus the standard of care in participants with previously untreated unresectable or metastatic urothelial cancer. In addition, a substudy of treatment with nivolumab 360mg in combination with SoC every 3 weeks for up to 6 cycles followed by nivolumab monotherapy versus SoC alone will be evaluated in cisplatin-eligible participants with previously untreated unresectable or metastatic urothelial cancer.

Principal Investigator: Gautam Jha

Sex: All

Age: 18 Years to old

Phase: Phase III

This study is NOT accepting healthy volunteers

System ID: STUDY00001304

IRB Number: STUDY00001304

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Interventions: Nivolumab, Ipilimumab, Gemcitabine, Cisplatin, Carboplatin, Nivolumab, Ipilimumab, Gemcitabine, Cisplatin, Carboplatin

Conditions: Urothelial Cancer

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HM2017-39 Phase III Randomized Study of Crenolanib versus Midostaurin Administered Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed Subjects with FLT3 Mutated Acute Myeloid Leukemia

Description:

This study is meant to compare the efficacy of crenolanib with midostaurin administered following induction chemotherapy and consolidation therapy on event-free survival (EFS) in newly diagnosed acute myeloid leukemia subjects with FLT3 mutation.

Principal Investigator: Mark Juckett

Sex: All

Age: 18 Years to 60 Years old

Phase: Phase 3

This study is NOT accepting healthy volunteers

System ID: STUDY00002581

IRB Number: STUDY00002581

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Interventions: Crenolanib, Midostaurin, Cytarabine, Duanorubicin, Crenolanib, Midostaurin, Cytarabine, Duanorubicin

Conditions: Newly Diagnosed FLT3 Mutated AML

Keywords: Clinics and Surgery Center (CSC)

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CAROTID REVASCULARIZATION AND MEDICAL MANAGEMENT FOR ASYMPTOMATIC CAROTID STENOSIS TRIAL (CREST-2) PROTOCOL (CREST-2)

Description:

CREST-2 is a parallel trial to compare carotid endarterectomy + intensive medical management (IMM) vs IMM alone, and carotid artery stenting plus IMM vs IMM alone in patients with asymptomatic carotid stenosis >70%.

Principal Investigator: Andrew Grande

Sex: All

Age: 35 Years to 100 Years old

Phase: N/A

This study is NOT accepting healthy volunteers

System ID: 1508M77101

IRB Number: 1508M77101

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General Inclusion Criteria Patients ≥35 years old. Carotid stenosis defined as: Stenosis ≥70% by catheter angiography (NASCET Criteria); OR by DUS with ≥70% stenosis defined by a peak systolic velocity of at least 230 cm/s plus at least one of the following: an end diastolic velocity ≥100 cm/s, or internal carotid/common carotid artery peak systolic velocity ratio ≥4.0, or CTA with ≥ 70% stenosis, or MRA with ≥ 70% stenosis. No medical history of stroke or TIA ipsilateral to the stenosis within 180 days of randomization. Life-long asymptomatic patients will be defined as having no medical history of stroke or transient ischemic attack and negative responses to all of the symptom items on the Questionnaire for Verifying Stroke-free Status (QVSS).18 Patients must have a modified Rankin Scale score of 0 or 1 at the time of informed consent. Women must not be of childbearing potential or, if of childbearing potential, have a negative pregnancy test prior to randomization. Patients must agree to comply with all protocol-specified follow-up appointments. Patients must sign a consent form that has been approved by the local governing Institutional Review Board (IRB)/Medical Ethics Committee (MEC) of the respective clinical site. Randomization to treatment group will apply to only one carotid artery for patients with bilateral carotid stenosis. Management of the non-randomized stenosis may be done in accordance with local PI recommendation. Treatment of the non-study internal carotid artery must take place at least 30 days prior to randomization, or greater than 44 days after randomization and 30 days after the study procedure is completed (whichever is longer). Carotid stenosis must be treatable with CEA, CAS, or either procedure. General Exclusion Criteria Intolerance or allergic reaction to a study medication without a suitable management alternative. GI hemorrhage within 1 month prior to enrollment that would preclude antiplatelet therapy. Prior major ipsilateral stroke in the past with substantial residual disability (mRS ≥ 2) that is likely to confound study outcomes. Severe dementia. History of major symptomatic intracranial hemorrhage within 12 months that was not related to anticoagulation. Prior Intracranial hemorrhage that the investigator believes represents a contraindication to the perioperative or periprocedural antithrombotic and antiplatelet treatments necessary to complete endarterectomy or stenting per protocol. Current neurologic illness characterized by fleeting or fixed neurologic deficits that cannot be distinguished from TIA or stroke. Patient objects to future blood transfusions. Platelet count <100,000/microliter or history of heparin-induced thrombocytopenia. Anticoagulation with Phenprocoumon (Marcumar®), warfarin, or a direct thrombin inhibitor, or anti-Xa agents. Chronic atrial fibrillation. Any episode of atrial fibrillation within the past 6 months or history of paroxysmal atrial fibrillation that is deemed to require chronic anticoagulation. Other high-risk cardiac sources of emboli, including left ventricular aneurysm, severe cardiomyopathy, aortic or mitral mechanical heart valve, severe calcific aortic stenosis (valve area < 1.0 cm2), endocarditis, moderate to severe mitral stenosis, left atrial thrombus, or any intracardiac mass, or known unrepaired PFO with prior paradoxical embolism. Unstable angina defined as rest angina with ECG changes that is not amenable to revascularization (patients should undergo planned coronary revascularization at least 30 days before randomization). Left Ventricular Ejection fraction <30% or admission for heart failure in prior 6 months. Respiratory insufficiency with life expectancy < 4 years or FEV1 <30% of predicted value. Known malignancy other than basal cell non-melanoma skin cancer. There are two exceptions to this rule: patients with prior cancer treatment and no recurrence for >5 years are eligible for enrollment and cancer patients with life expectancy of greater than 5 years are eligible for enrollment. Any major surgery, major trauma, revascularization procedure, or acute coronary syndrome within the past 1 month. Either the serum creatinine is ≥ 2.5 mg/dl or the estimated GFR is < 30 cc/min. Major (non-carotid) surgery/procedures planned within 3 months after enrollment. Currently listed or being evaluated for major organ transplantation (i.e. heart, lung, liver, kidney). Actively participating in another drug or aortic arch or cerebrovascular device trial for which participation in CREST-2 would be compromised with regard to follow-up assessment of outcomes or continuation in CREST-2. Inability to understand and cooperate with study procedures or provide informed consent. Non-atherosclerotic carotid stenosis (dissection, fibromuscular dysplasia, or stenosis following radiation therapy). Previous ipsilateral CEA or CAS. Ipsilateral internal or common carotid artery occlusion. Intra-carotid floating thrombus. Ipsilateral intracranial aneurysm > 5 mm. Extreme morbid obesity that would compromise patient safety during the procedure or would compromise patient safety during the periprocedural period. Coronary artery disease with two or more proximal or major diseased coronary arteries with 70% stenosis that have not, or cannot, be revascularized. Specific carotid endarterectomy exclusion criteria Patients who are being considered for revascularization by CEA must not have any of the following criteria: Serious adverse reaction to anesthesia not able to be overcome by pre-medication. Distal/intracranial stenosis greater than index lesion. Any of the following anatomical: radical neck dissection; surgically inaccessible lesions (e.g. above cervical spine level 2 (C2)); adverse neck anatomy that limits surgical exposure (e.g. spinal immobility - inability to flex neck beyond neutral or kyphotic deformity, or short obese neck); presence of tracheostomy stoma; laryngeal nerve palsy contralateral to target vessel; or previous extracranial-intracranial or subclavian bypass procedure ipsilateral to the target vessel. Specific Carotid Artery Stenting Exclusion Criteria Patients who are being considered for revascularization by CAS must not have any of the following criteria: Allergy to intravascular contrast dye not amenable to pre-medication. Type III, aortic arch anatomy. Angulation or tortuosity (≥ 90 degree) of the innominate and common carotid artery that precludes safe, expeditious sheath placement or that will transmit a severe loop to the internal carotid after sheath placement. Severe angulation or tortuosity of the internal carotid artery (including calyceal origin from the carotid bifurcation) that precludes safe deployment of embolic protection device or stent. Severe tortuosity is defined as 2 or more ≥ 90 degree angles within 4 cm of the target stenosis. Proximal/ostial CCA, innominate stenosis or distal/intracranial stenosis greater than index lesion. Excessive circumferential calcification of the stenotic lesion defined as >3mm thickness of calcification seen in orthogonal views on fluoroscopy.(Note: Anatomic considerations such as tortuosity, arch anatomy, and calcification must be evaluated even more carefully in elderly subjects (≥ 70 years).) Target ICA vessel reference diameter <4.0 mm or >9.0 mm. Target ICA measurements may be made from angiography of the contralateral artery. The reference diameter must be appropriate for the devices to be used. Inability to deploy or utilize an FDA-approved Embolic Protection Device (EPD). Non-contiguous lesions and long lesions (>3 cm). Qualitative characteristics of stenosis and stenosis-length of the carotid bifurcation (common carotid) and/or ipsilateral external carotid artery, that preclude safe sheath placement. Occlusive or critical ilio-femoral disease including severe tortuosity or stenosis that necessitates additional endovascular procedures to facilitate access to the aortic arch or that prevents safe and expeditious femoral access to the aortic arch. "String sign" of the ipsilateral common or internal carotid artery. Angiographic, CT, MR or ultrasound evidence of severe atherosclerosis of the aortic arch or origin of the innominate or common carotid arteries that would preclude safe passage of the sheath and other endovascular devices to the target artery as needed for carotid stenting.

Interventions: Carotid endarterectomy (CEA), Carotid Stenting (CAS), Intensive Medical Management - no CEA, Intensive Medical Management - no CAS, Carotid endarterectomy (CEA), Carotid Stenting (CAS), Intensive Medical Management - no CEA, Intensive Medical Management - no CAS

Conditions: Carotid Stenosis

Keywords: asymptomatic, carotid, stent, endarterectomy, embolic protection, medical management, hypertension, hyperlipidemia, cognition, risk factor control

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COG ALTE1631 - A Randomized Web-based Physical Activity Intervention among Children and Adolescents with Cancer

Description:

Regular participation in physical activity helps maintain a healthy weight, improves energy levels and overall health. Children and teenagers who have received treatment for cancer are often less active, may gain weight and have more health problems as compared to children and teenagers who have not received treatment for cancer. This study looks at physical activity and its effect on your health. This study will use a variety of interventions to see if they affect how active you are over time.

Principal Investigator: Lucie Turcotte

Sex: All

Age: 8 Years to 16 Years old

Phase: Phase 3

This study is NOT accepting healthy volunteers

System ID: STUDY00004806

IRB Number: STUDY00004806

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Interventions: Educational Intervention, Internet-Based Intervention, Internet-Based Intervention, Laboratory Biomarker Analysis, Medical Device Usage and Evaluation, Quality-of-Life Assessment, Questionnaire Administration, Educational Intervention, Internet-Based Intervention, Internet-Based Intervention, Laboratory Biomarker Analysis, Medical Device Usage and Evaluation, Quality-of-Life Assessment, Questionnaire Administration

Conditions: Carcinoma In Situ, Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm

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DORA Trial: Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Description:

Compare overall survival for subjects treated with docetaxel versus subjects treated with docetaxel plus radium-223.

Principal Investigator: Gautam Jha

Sex: Male

Age: 18 Years to old

Phase: Phase 3

This study is NOT accepting healthy volunteers

System ID: STUDY00011960

IRB Number: STUDY00011960

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Inclusion Criteria:

Willing and able to provide written informed consent (ICF) and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed. NOTE: HIPAA authorization may be either included in the informed consent or obtained separately. Males 18 years of age and above Histological or cytological proof of prostate cancer Documented progressive mCRPC based on at least one of the following criteria: PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 1.0 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 1.0 ng/mL. Soft-tissue progression defined as an increase ≥ 20% in the sum of the LD of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions. Progression of bone disease (evaluable disease) or two or more new bone lesions by bone scan. Two or more bone lesions ECOG 0- 1 Normal organ function with acceptable initial laboratory values within 14 days of randomization: Albumin > 30 g/L ANC ≥ 1.5 x 10^9/L Hemoglobin ≥ 10 g/dL Platelet count ≥ 100 x 10^9/L Creatinine ≤ 1.5 x the institutional upper limit of normal (ULN) Bilirubin ≤ ULN (unless documented Gilbert's disease) SGOT (AST) ≤ 1.5 x ULN SGPT (ALT) ≤ 1.5 x ULN WBC count ≥ 3 x 10^9/L Subjects must agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 30 days after the last dose of study drug. Sperm donation is prohibited during the study and for 30 days after the last dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent. Serum testosterone < 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH analogue (agonist or antagonist) if they have not undergone orchiectomy. All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 Grade 1 or less. Willing and able to comply with the protocol, including follow-up visits and examinations

Exclusion Criteria:

Received any other investigational therapeutic agents or other anticancer therapies within 4 weeks prior to randomization. Received external beam radiotherapy within the 4 weeks prior to randomization. Has an immediate need for external beam radiotherapy. Has received any systemic bone-seeking radiopharmaceutical in the past. Has received any prostate cancer directed chemotherapy in the castration resistant setting. Subjects who have received up to 6 prior doses of docetaxel in the castration sensitive setting are permitted if they have not experienced disease progression within 36 weeks of last treatment with docetaxel. Has received four or more systemic anticancer regimens for mCRPC. Treatment with docetaxel or abiraterone for non-castrate metastatic disease is permissible and does not count towards the lines of therapy for mCRPC A 'line' is a regimen. Combinations of hormones and other types of therapies count as single lines. Has known Grade ≥3 docetaxel-related toxicities or docetaxel toxicity related dose interruption or discontinuation. Has received blood transfusions or growth factors within the last 4 weeks prior to randomization. Symptomatic nodal disease (i.e., scrotal, penile, or leg edema). Has visceral metastases with ≥ 3 lung and/or liver metastases or individual lesion ≥2 cm, as assessed by CT scan or MRI of the chest/abdomen/pelvis within the last 8 weeks prior to randomization. Symptomatic loco-regional disease that causes ongoing Grade 3 or Grade 4 urinary or rectal symptoms. Subjects with a "currently active" second malignancy other than non-melanoma skin cancers or non-invasive bladder cancers or other in-situ or non-invasive malignancies. Subjects are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years. Has imminent or established cord compression based on clinical findings and/or MRI. Known bone marrow dysplasia Has received any of the following in the 4 weeks prior to randomization: 5-alpha-reductase inhibitors, herbal medications, natural hormonally active foods (e.g., phytoestrogens) or other food supplements known to alter PSA in humans Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous, including but not limited to: Uncontrolled infection NYHA III or IV heart failure Crohn's disease or those with ulcerative colitis who have not undergone a colectomy Known active infection with HIV, Hepatitis B or Hepatitis C

Interventions: Docetaxel 75 mg/m2, Docetaxel 60 mg/m2, Radium-223, Docetaxel 75 mg/m2, Docetaxel 60 mg/m2, Radium-223

Conditions: Prostate Cancer

Keywords: Clinics and Surgery Center (CSC)

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Chilled Platelet Study (CHIPS)

Description:

The purpose of this research study is to compare the transfusion of cold-stored (refrigerated) platelets to standard room temperature stored platelets. The goal of the trial is to determine whether platelets stored cold are similar or better at stopping bleeding compared to platelets stored at room temperature and, if so, to determine the maximum duration of cold storage that maintains a similar effect on bleeding

Principal Investigator: Claudia Cohn

Sex: All

Age: 29 Days to 84 Years old

Phase: Phase 3

This study is NOT accepting healthy volunteers

System ID: STUDY00013172

IRB Number: STUDY00013172

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Interventions: Cold Stored Platelets, Room Temperature Platelets, Cold Stored Platelets, Room Temperature Platelets

Conditions: Acute Blood Loss

Keywords: platelets, cold-stored platelets, bleeding, hemostasis, complex cardiac surgery

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Prospective tReatment EffiCacy in IPF uSIng genOtype for Nac Selection (PRECISIONS) trial (PRECISIONS)

Description:

Patients with idiopathic pulmonary fibrosis (IPF) that have the TOLLIP rs3750920 TT genotype will be treated with N-acetyl cysteine (NAC) compared to placebo, while receiving standard care. Standard of care is defined as allowing background therapy with FDA-approved medications for IPF, such as pirfenidone or nintedanib, if taking a stable dose for at least 6 weeks prior to enrollment.

Principal Investigator: Hyun Kim

Sex: All

Age: 40 Years to old

Phase: Phase 3

This study is NOT accepting healthy volunteers

System ID: STUDY00012926

IRB Number: STUDY00012926

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Interventions: N-acetyl cysteine, Placebo, N-acetyl cysteine, Placebo

Conditions: Idiopathic Pulmonary Fibrosis

Keywords: Clinics and Surgery Center (CSC)

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HPS-4/TIMI 65/ORION-4: A Double-blind Randomized Placebo-controlled Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Atherosclerotic Cardiovascular Disease (ORION-4)

Description:

The HPS-4/TIMI 65/ORION-4 study aims to provide evidence about both the efficacy and safety of inclisiran. It is intended to be conducted at approximately 150 clinical sites in Europe (primarily in the UK) and North America. Approximately 15,000 participants aged 55 years or older with pre-existing atherosclerotic cardiovascular disease will be randomized between inclisiran sodium 300 mg and matching placebo (given by subcutaneous injection on the day of randomization, at 3 months and then every 6-months) in a 1:1 ratio for a planned median duration of about 5 years. Consistent with relevant guideline recommendations for people with vascular disease, it is intended that participants be on intensive background LDL-lowering therapy (for example, atorvastatin 40 or 80 mg daily, simvastatin 40 or 80 mg daily, or rosuvastatin 20 or 40 mg daily) at screening. In order to achieve a target LDL cholesterol reduction of at least 1.2 mmol/l [45 mg/dL], it is intended to recruit a study population with a mean LDL cholesterol of at least 2.6 mmol/l [100mg/dL] at baseline.

Principal Investigator: Les Forgosh

Sex: Male or Female

Age: 18 Years and over

Phase: Phase III

This study is NOT accepting healthy volunteers

System ID: STUDY00009102

IRB Number: STUDY00009102

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Interventions: Inclisiran, Placebo, Inclisiran, Placebo

Conditions: Heart & Vascular

Keywords: Heart Disease

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myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD patients in the home - a multi-center randomized controlled trial

Description:

Parallel-group, prospective, randomized, controlled phase III trial of home High flow Nasal Therapy (HFNT) via myAirvo 3 plus usual COPD medical care vs. usual COPD medical care, for at least 1 year and up to two years in 642 GOLD Grade D, Stages III-IV patients with moderate to very severe COPD at risk for moderate and severe exacerbations with a prior history of severe exacerbation requiring hospitalization within the past 6 weeks.

Principal Investigator: Nathaniel Gaeckle

Sex: All

Age: 40 Years to old

Phase: Phase III

This study is NOT accepting healthy volunteers

System ID: STUDY00016166

IRB Number: STUDY00016166

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Inclusion Criteria:

To be eligible to participate in this study, an individual must meet all the following criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, aged 40 years or greater Documented history of moderate to very severe COPD (GOLD stages III - IV, Grade D) MRC ≥ 2 or CAT ≥ 10 ≥ 10 pack-year history of smoking History of a severe COPD exacerbation requiring hospitalization in the previous six weeks Recent spirometry (within the previous three months) that shows an FEV1 post bronchodilator is < 50% predicted COPD in a stable state after hospitalization defined as: Clinically stable condition and have had no parenteral therapy for 24 hours. Inhaled bronchodilators are required less than four-hourly. Oxygen delivery has ceased for 24 hours (unless home oxygen is indicated). If previously able, the patient is ambulating safely and independently, and performing activities of daily living. The patient can eat and sleep without significant episodes of dyspnea. The patient or caregiver understands and can administer medications. Follow-up and home care arrangements (e.g., home oxygen, homecare, Meals on Wheels, community nurse, allied health, GP, specialist) have been completed. Willing to adhere to the daily use of the myAirvo 3 regimen for at least 8 hours each day preferably at night following being shown and using the device Willing to record daily symptoms and pulse oximetry and heart rate on daily basis For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation Highly effective contraception is defined as: A tubal ligation: An approved hormonal contraceptive such as oral contraceptives, emergency contraception used as directed, patches, implants, injections, rings or intrauterine devices 13. Able to read and communicate in English 14. Have a home environment suitable for myAirvo 3 use. 15. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:
• Current self-reported chronic use of positive airway pressure (PAP) therapy; continuous positive airway pressure (CPAP), or non-invasive positive pressure ventilation (NPPV) 2. A STOPBang Questionnaire score > = 5 3. Pregnancy or lactation 4. Treatment with another investigational drug or other intervention within the previous 30 days 5. Life expectancy less than 12 months due to COPD or other comorbid condition. 6. Recent upper airway surgery 7. Recent head or neck trauma 8. Inability to tolerate nasal prongs 9. Requirement of oxygen greater than 15 L/min -

Interventions: myAirvo3, Pulse oximeter, myAirvo3, Pulse oximeter

Conditions: COPD

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