
Search Results
Cannabidiol (CBD) and Stress Response: Psychobiological Mechanisms
This study includes healthy adults between the ages of 21-70 who either use or do not cannabidiol (CBD) regularly. The purpose of this study is to learn about how CBD users and nonusers respond to stress. Participants must be willing to attend one in-person visit at the University of Minnesota Duluth campus
• 21 to 70 years old
• generally healthy
• use CBD regularly or do not use CBD
• willing to attend one in-person visit at the University of Minnesota Duluth campus
• current, unstable physical or mental health condition
• women who are currently pregnant
• current use of illicit substances (other than cannabis)
A Phase 1 Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ACE-232 in Patients with Metastatic Castration-Resistant Prostate Cancer (CRPC)
The purpose of this research is to collect information about the safety and tolerability of the study drug ACE-232, along with how well it works to control metastatic castration-resistant prostate cancer (mCRPC).
• diagnosis of Metastatic Castration-resistant Prostate Cancer (MCRPC) with - ongoing androgen deprivation therapy (ADT) or had bilateral orchiectomy
• difficult to treat or intolerant to standard treatment
• may be restricted in physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete inclusion criteria
• spinal cord compression or known brain metastases
• severe cardiovascular disorders
• known gastrointestinal (GI) disorder or GI procedure
• poorly controlled diabetes
• active or uncontrolled autoimmune disease
• see link to clinicaltrials.gov for complete exclusion criteria
A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician s Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05)
The purpose of this study is to see if sacituzumab govitecan in combination with pembrolizumab can improve outcomes and delay the return of disease in participants with high-risk early Triple Negative Breast Cancer (TNBC) when compared to pembrolizumab alone or pembrolizumab in combination with capecitabine. Participants with low tumor expression of the estrogen and/or progesterone receptors (1 to 10%) will also be included in this study. The study treatment will be chosen by chance—like flipping a coin. There is a 1 out of 2 chances to receive Sacituzumab govitecan in combination with Pembrolizumab and 1 out of 2 chances to receive a study treatment of study doctor’s choice of either pembrolizumab alone or pembrolizumab in combination with capecitabine. Participants and their study doctor will know what study drug is being taken.
• invasive triple negative breast cancer (TNBC) still remains in the breast or lymph nodes after therapy and surgery
• unable to do physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• Stage IV (metastatic) breast cancer or previous cancer in the same or other breast
• evidence that the cancer has reoccurred after preoperative therapy and surgery
• presence of germline breast cancer gene (BRCA) mutations
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
• patients must be > 365 days and < 25 years of age
• participant has newly diagnosed B-ALL or MPAL with ≥25% blasts on a bone marrow (BM) aspirate or newly diagnosed B-LLy
• see link to clinicaltrials.gov for complete inclusion criteria
• patients with Down syndrome are not eligible
• patients with acute undifferentiated leukemia (AUL) are not eligible
• 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.
• see link to clinicaltrials.gov for complete exclusion criteria
Intraperitoneal FT536 in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
FT536 is a type of cell product made up of “natural killer” or NK cells. NK cells are a type of immune blood cell that are known to attack cancer cells. FT536 is produced by growing cells that come from a healthy human donor. The primary purpose of this study is to identify a safe dose of FT536 cells when given alone (monotherapy).
• epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer that has recurred after treatment (no limit to the maximum number of prior treatments)
• must have received prior bevacizumab
• if there is a BRCA mutation, must have received a prior PARP inhibitor
• agree to the have an intraperitoneal catheter placed before the 1st dose of study drug
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• women who are pregnant, breastfeeding or planning to become pregnant in the next 6 months
• active autoimmune disease requiring systemic immunosuppressive therapy
• history of severe asthma and currently on chronic medications (more than inhalers)
• received enoblituzumab
• CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or needing medications for these conditions in the past 2 years
A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK) (EPPIK)
Currently, there are no approved treatment options for pediatric subjects with proteinuric kidney conditions. The study will look at the safety, efficacy, and pharmacokinetic (PK) trial in children ≥1 to <18 years treated for up to 108 weeks with the drug sparsentan.
• Child 1 to 18 years old
• Diagnosed by biopsy with specific types of glomerular disease & protein in the urine
• Blood pressure is within normal range for age
• Maintained on a stable dose of immunosuppressive medications
• Weight less than 7.3 kg 16 pounds) at screening.
• Disease due to to viral infections, drug toxicities, or cancer.
• Kidney function is below the minimum required
ALTE22C1, Chronic Health Conditions in Down Syndrome-Associated Acute Leukemia: The Down Syndrome Phenotyping Acute Leukemia Study in Survivors (DS-PALS Survivors)
To determine the prevalence, type, and severity of chronic health conditions (CHC) in survivors of Down syndrome-associated acute leukemia (DS-AL), and to compare CHC with frequency-matched DS individuals that have no cancer history.
• Age: Patients age >= 6 and < 40 years at the time of enrollment.
• A diagnosis of Down Syndrome is required; all patients must be DS-AL survivors and have been treated for ALL or AML.
• All cancer treatment must have been completed at least 36 calendar months prior to enrollment.
• Patients with history of Hematopoietic Stem Cell Transplant (HSCT) are excluded.
• Patients with a history of cancer prior to their ALL or AML diagnosis are excluded. Patients that developed a subsequent malignant neoplasm following their ALL or AML diagnosis are also excluded.
• Patients whose parents or guardians are unable to complete the required forms are excluded.
Neural underpinnings of understanding speech in different listening contexts
This study evaluates the neural underpinnings of understanding speech in different listening contexts, such as listening to two talkers simultaneously or speech in background noise.
• Group 1: Adults aged 18-70 years, normal hearing, proficient in spoken English
• Group 2: Adults aged 18-70 years, have hearing loss, proficient in spoken English
• Neurological problems
• auditory neuropathy spectrum disorder (ANSD)
• Wear a cochlear implant
A Randomized Double Blind Phase II Trial of Restorative Microbiota Therapy (RMT) or Placebo in Combination with Durvalumab (MEDI4736) and Tremelimumab With Chemotherapy in Treatment Naïve Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer
The investigational therapy in this study is referred to as Restorative Microbiota Therapy (RMT). It is prepared by extracting healthy bacteria from the stool of healthy human donors and making it into capsules taken by mouth. The donor stool samples are rigorously tested for harmful bacteria and viruses before processing. There is scientific evidence to suggest that RMT might make immunotherapy more effective. The primary goal of the study is to test if RMT makes durvalumab + tremelimumab treatment with chemotherapy more effective to control lung cancer.
• confirmed adenocarcinoma of the lung that is stage IIIB/C or stage IV that can't be surgically removed
• prior chemotherapy or immunotherapy as adjuvant therapy for lung cancer is permitted as long as it has been more than 6 months from last dose
• people who have treated brain metastasis are eligible as long as they have stable symptoms, are more than 2 weeks from completion of therapy, and do not require more than 10mg of daily prednisone or equivalent
• restricted in strenuous physical activity but can walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• weigh at least 30 kg (66 lbs.)
• contact study staff for additional requirements
• women who are pregnant or breast feeding
• unable to swallow medications
• additional medical and mental health diagnosis (study staff will review)
MT2020-35 - COG AAML1831 - A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations
The overall goal of this study is to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, and to find out what effects, good and/or bad, the drug gilteritinib has when given with chemotherapy to children and young adults with newly diagnosed AML and the FLT3/ITD mutation or non-ITD FLT3 activating mutations.
• patients must be less than 22 years of age at the time of study enrollment
• all patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to enrollment and treatment on AAML1831
• patient must be newly diagnosed with de novo Acute Myeloid Leukemia (AML)
• see link to clinicaltrials.gov for additional inclusion criteria
• any concurrent malignancy
• female patients who are pregnant
• lactating females who plan to breastfeed their infants
• see link to clinicaltrials.com for additional exclusion criteria
Screening Study to Determine HLA Type, HLA Loss of Heterozygosity Status and Tumor Antigen Expression in Participants with Locally Advanced (Unresectable) or Metastatic Solid Tumors
The purpose of this screening study is to collect samples to conduct the testing of specific human leukocyte antigen (HLA). TScan Therapeutics is developing cellular therapies across multiple solid tumors in which the eligibility criteria require that participants have specific HLA types. The results from this screening study will be used to determine if participants meet the eligibility criteria and could potentially be enrolled in a future TScan treatment study.
• have one of the following confirmed locally advanced (unresectable) or metastatic solid tumor: Head and neck cancer, cervical cancer, non-small cell lung cancer, melanoma, ovarian cancer, HPV positive anogenital cancer HPV positive anogenital cancers
• undergoing anticancer therapy with curative intent
The Parallel Auditory Brainstem Response
This study aims to test the accuracy and speed of the pABR for future clinical use by recruiting adults with a range of hearing loss profiles from normal hearing to severe loss.
• age 18-65 years
• hearing loss (can be from none to severe)
• no history of auditory neuropathy spectrum disorder or cochlear implant use
• can remain still or sleep for the test duration
• profound hearing loss (thresholds > 80 dB HL)
• cochlear implant use
• auditory neuropathy spectrum disorder
• abnormal tympanogram
• inability to sleep or remain very still for the duration of the test
MT2023-35: A Pilot Study to Identify Risk Factors for Long-Term Functional and Pulmonary Outcomes Following Allogeneic Hematopoietic Cell Transplantation for Oncologic Diagnoses.
The purpose of this study is to help investigators learn more about lung problems after bone marrow transplant including what are the best methods for diagnosing lung problems and follow-up care. The lung problems that may develop after transplant varies from patient to patient, and we don’t exactly know what risk factors influence who develops them or how patients respond to pulmonary (breathing system) therapies. Also, we wish to improve how we monitor lung function and quality of life after transplant, especially in children and young adults.
• age 0 to 25 years at the time of Hematopoietic Cell Transplantation (HCT)
• received stem cell transplant for cancer
• receive ongoing care at the University of Minnesota Childhood Cancer/BMT Survivor Program
• people who don't speak or read English
MT2023-42: A Phase 1 Study of FT819 in B-Cell Mediated Autoimmune DIseases
This study will test the safety of FT819, an experimental cell product, in people with severe active systemic lupus erythematosus. The purpose of this study is to understand the way someone's body processes and responds to FT819, and to find out what effects FT819 may have on a person and their systemic lupus erythematosus.
• between 18 and 40 years old
• diagnosed with Systemic Lupus Erythematosus (SLE)
• failure to respond to glucocorticoids and ≥2 of the following treatments for at least 3 months: cyclophosphamide (CY), mycophenolic acid or its derivatives, belimumab, methotrexate, azathioprine, anifrolumab, rituximab, obinutuzumab, cyclosporin, tacrolimus, or voclosporin
• active neurological symptoms of SLE
• CNS disease such as stroke, epilepsy, or neurodegenerative disease in the past two years
• prior treatment with CAR T-cell therapy, allograft organ transplant, or hematopoietic stem cell transplant
Identifying hearing loss through neural responses to engaging stories
This research study will develop an efficient electroencephalographic (EEG) method that uses narrated stories to identify frequency-specific hearing loss.
• Adults aged 18-70 years, hearing loss with thresholds better than 70 dB HL, no history of neurological problems or ANSD, doesn’t wear a cochlear implant
• Neurological problems
• ANSD
• Wears a cochlear implant
Effect of Kava on Anxiety and Stress in Cancer Survivors
Anxiety and stress are significant problems for cancer survivors. The purpose of this study is to learn what effect a 14-day course of kava can have on anxiety and stress in cancer survivors, and about the side effects of kava for cancer survivors.
• Adult ≥ 18 years old
• Completed curative-intent treatment for breast, gynecologic, lung, or head/neck cancer within the last 24 months without clinical and/or radiographic evidence of recurrence at the time of the last follow up
• Willing to abstain from benzodiazepine and alcohol use during the kava or placebo intervention and for at least 14 days after completion
• Known allergy to kava
• Regular use of benzodiazepines, defined as ≥ 2 times weekly, within 14 days prior to study registration
• Use of herbal supplements within 14 days of study registration,
• Anti-cancer therapy within 28 days prior to registration and/or during study participation, except for aromatase inhibitors
• Known liver disease such as cirrhosis
• Use of acetaminophen at doses more than 2000 mg daily for more than three days per week within 7 days prior to the first dose of kava or placebo intervention
• Chronic use of high-intensity statin therapy
• Women who are pregnant, intend to become pregnant, or are nursing
ACNS2321; A Phase II Trial Evaluating Chemotherapy followed by Response-Based Reduced Radiation Therapy for Patients with Central Nervous System Germinomas
This study aims to reduce the radiotherapy (RT) dose necessary to successfully treat patients with intracranial germ cell tumors who are in a state of complete response (CR) following chemotherapy. In this study, a further reduction in whole ventricular irradiation (WVI) will be tested. The primary aim of the study is to determine whether 12 Gy of WVI, and 12 Gy tumor boost, would be successful. Event-free survival (EFS) in patients with central nervous system germinoma, who meet criteria for CR or continued complete response (CCR) following chemotherapy/second-look surgery, would be the primary measurement of success.
• Age: Patients must be ≥ 3 years and < 30 years at the time of study enrollment. Diagnosis:
• Patients must be newly-diagnosed primary localized germinoma of the suprasellar and/or pineal region by pathology and/or serum and/or CSF hCGβ 5-50 mIU/mL AND institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists), including tumors with contiguous ventricular or unifocal parenchymal extension. No histologic confirmation required.
• Patients with bifocal (pineal + suprasellar) involvement or pineal lesion with diabetes insipidus (DI) AND hCGβ ≤ 100 mIU/mL in serum and/or CSF AND institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists) in both serum and CSF. No histologic confirmation required.
• Patients with hCGβ 51-100 mIU/mL in serum and/or CSF and institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists) in both serum and CSF. Histologic confirmation of germinoma IS required.
• Patients with germinoma of the basal ganglia and or/thalamic primary sites are eligible.
• Patients with metastatic germinoma including non-contiguous disease or distant disease in the brain, ventricles, or spine are eligible.
• Patients with germinoma admixed with mature teratoma are eligible.
• Patients with any of the following malignant pathological elements are not eligible: endodermal sinus (yolk sac), embryonal carcinoma, choriocarcinoma, malignant/immature teratoma and mixed GCT (i.e., may include some germinoma).
• Patients with only mature teratoma upon tumor sampling at diagnosis and negative tumor markers are not eligible.
• Patients who have received any prior tumor-directed therapy for their diagnosis of germinoma other than surgical intervention and corticosteroids are not eligible.
Developing and pilot testing an intervention to reduce household shisha smoke exposure within Somali homes
In this study, we want to find out more about secondhand smoke from shisha smoking in the home. We want to help families learn more about the risks of shisha smoke in the home and find ways to stop smoking at home.
• families who identify as Somali American
• have one or more children between 6 months and 18 years of age in the home
• have at least one adult who uses shisha at home
• families with other forms of tobacco use in addition to shisha use will be included
• inability or unwillingness to complete all study procedures
A Randomized, Controlled, Multicenter, Phase 3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination with Nivolumab Versus Treatment of Physician s Choice in Patients with Advanced Melanoma That Has Progressed on an Anti-PD-1 and an Anti-CTLA-4 Containing Treatment Regimen [IGNYTE-3]
The purpose of this research is to compare the effects of nivolumab with vusolimogene oderparepvec (VO) against standard of care treatment drug(s) currently available for patients with advanced melanoma. We expect that taking part in this research will last up to 60 months.
• at least 12 years old
• confirmed metastatic Stage IIIb through IV/M1a through M1d cutaneous melanoma that cannot be surgically removed
• disease progression (PD) on an approved anti-PD-1 and an anti-CTLA-4 treatment, administered either as a combination regimen (eg, nivolumab + ipilimumab) or in sequence for at least 8 weeks
• documented BRAF V600 mutation status
• see link to clinicaltrials.gov for complete inclusion criteria
• more than 2 lines of systemic therapy for advanced melanoma
• known acute or chronic hepatitis
• known human immunodeficiency virus (HIV) infection
• prior cancer in the previous 3 years, except for locally curable cancers that have apparently been cured
• see link to clinicaltrials.gov for complete exclusion criteria
MT2024-05: A Phase I, First in Human Open Label Study to Evaluate the Safety and Tolerability of TRX103 cell infusion in subjects with hematological malignancies undergoing HLA-mismatched related or unrelated hematopoietic stem cell transplantation (HSCT)
This study will enroll patients with a blood cancer who need to undergo a stem cell (bone marrow) transplant using a donor that is not a full DNA match with them. It tests TRX103, a cellular therapy, to see if it is an effective and safe way to prevent Graft versus Host Disease (GvHD), a common and potentially serious side effect of stem cell transplant.
• undergoing mismatched related (haploidentical) or unrelated allogeneic hematopoietic stem cell transplantation (HSCT)
• diagnosis of one of the following hematologic malignancies: Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), or Chronic myelomonocytic leukemia (CMML)
• weight is at least 35 kgs (77 pounds)
• available mismatched related (haploidentical) or unrelated donors for peripheral blood stem cell (PBSC) donation
• study staff will review additional inclusion and exclusion criteria
• prior allogeneic bone marrow, peripheral blood, or cord blood HSCT
• HIV positive, positive hepatitis-B surface antigen or positive hepatitis-C antibody (unless treated)
• women who are pregnant, breast feeding or aim to become pregnant during the study period
ELEVATE, a global observational longitudinal prospective registry of patients with acute hepatic porphyria (AHP) (ELEVATE)
This is a global, multicenter, prospective, observational, longitudinal registry conducted to characterize the natural history and real-world clinical management of patients diagnosed with AHP. This protocol will not recommend the use of any specific treatments, visits, or procedures. No medication is provided as part of registry participation.
MT2023-22: Phase 1/2 Study of IDP-023 as a Single Agent and in Combination with Antibody Therapies in Patients with Advanced Hematologic Cancers
There are 2 phases to this clinical research study: Phase 1 (dose escalation) and Phase 2 (dose expansion). The goal of Phase 1 is to find the recommended dose of the study drug IDP-023 that can be given alone (referred to as a “monotherapy”), with or without interleukin-2 (IL-2) and in combination with another anti-cancer drug, either daratumumab in subjects with relapsed/refractory MM or rituximab in subjects with relapsed/refractory NHL. The goal of Phase 2 is to learn if the recommended dose of IDP-023 found in Phase 1 with or without IL-2 can help to control advanced MM or NHL when given in combination with daratumumab or rituximab, respectively.
• diagnosis of Multiple Myeloma (MM) that has relapsed or is refractory disease after 3 or more prior lines of therapy
• OR Non-Hodgkin Lymphoma (NHL) that has relapsed or is refractory after 2 or more lines of chemotherapy
• restricted in physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• significant cardiac disease
• Human immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection
• untreated central nervous system, epidural tumor metastasis, or brain metastasis
Evaluation of an oral microbiota-based therapeutic as a treatment option for primary sclerosing cholangitis
We are studying the safety and feasibility of microbiota transplant therapy (MTT) for patients with Primary Sclerosing Cholangitis (PSC). The purpose of this study is to evaluate whether MTT from a healthy donor is safe and can be used to restore the healthy composition of microbiota to help decrease disease severity and improve symptoms. All patients in this study will receive capsules of the drug, MTT.
• ages 18-76
• serum total bilirubin ≤ 2x the upper limit of normal
• expect to maintain current medication regimen for the duration of the study
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• received antibiotic therapy (except vancomycin) in the past 3 months
• complications of advanced PSC, such as hepatic encephalopathy, ascites, history of esophageal varices, portal hypertension, hepato-renal syndrome, portopulmonary syndrome, and hepato-pulmonary syndrome
• viral hepatitis (history of Hepatitis C is eligible with undetectable HCV RNA); HIV/AIDS
• liver disease such as metabolic or inherited disease or cirrhosis
• women who are pregnant, breast feeding, or trying to become pregnant -active cancer
• active alcohol overuse (>4 drinks per day for men, and >2 drinks per day for women)
MT2023-06: A CLINICAL STUDY TO ASSESS THE EFFICACY AND SAFETY OF LERIGLITAZONE IN ADULT MALE SUBJECTS WITH CEREBRAL ADRENOLEUKODYSTROPHY (CALYX)
This study has 2 parts: a double-blind period and an open-label extension. In the double-blind period of this study, the study medicine will be compared to a placebo. A placebo is a treatment that looks and tastes exactly like the study medicine but does not contain any active ingredient. In this study, you will receive leriglitazone or placebo. Whether you receive leriglitazone or placebo will be decided randomly (by chance, like flipping a coin). In this study, 1 out of every 2 subjects (50%) will receive leriglitazone and 1 out of every 2 subjects (50%) will receive placebo. To make this study fair, you and the study doctor will not be told which treatment you will receive, this is called “blinding”. In the open-label extension, all subjects will receive leriglitazone.
• diagnosis of progressive cerebral adrenoleukodystrophy (cALD), defined as GdE with brain lesions
• bone marrow transplantation (HSCT) is not recommended patient is not willing to undergo HSCT
• no major cognitive impairment
• see link to clinicaltrials.gov for additional inclusion criteria
• or treatment with ex-vivo gene therapy (eli-Cel).
• known type 1 or type 2 diabetes
• see link to clinicaltrials.gov for additional exclusion criteria
DAS181-3-01: A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects
This research study is for participants who have a weakened immune system (are immunocompromised), have a lower lung infection and are currently using a machine or device to help them breathe. The study will look at whether the study drug, DAS181, works and how safe it is compared with a placebo in adults who have a weakened immune system (immunocompromised) and a parainfluenza virus (PIV) infection of the lower respiratory tract. A placebo looks the same as the study drug but does not contain any active ingredients.
• needs supplemental oxygen ≥2 liters/minute due to low oxygen levels
• immunocompromised, as defined by one or more of the following: received a stem cell transplant, organ transplant, being treated with chemotherapy for hematologic malignancies (e.g., leukemia, myeloma, lymphoma) and/or solid tumor malignancies (e.g., lung, breast, brain cancer) at any time in the past, or has an immunodeficiency due to congenital abnormality
• men and women of childbearing potential must use effective birth control
• see link to clinical trials.gov for complete inclusion criteria
• women who are pregnant or breastfeeding or planning to breastfeed at any time through 30 days after the last dose of study drug
• taking any other investigational drug used to treat pulmonary infection
• severe sepsis
• see link to clincialtrials.gov for complete exclusion criteria
ITCC-101/APAL2020D - A randomized phase 3 trial of fludarabine/cytarabine/gemtuzumab ozogamicin with or without venetoclax in children with relapsed AML (A subtrial of the PedAL/EuPAL relapsed acute leukemia master protocol)
A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone (fludarabine/cytarabine/gemtuzumab ozogamicin [GO]) improves survival of children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are unable to receive additional anthracyclines, or in 2nd relapse.
• participants must be at least 29 days of age and less than 21 years of age at enrollment
• participants must have enrolled on APAL2020SC, NCT Number: NCT04726241
• children, adolescents, and young adults with acute myeloid leukemia without FLT3/internal tandem duplication (ITD) mutation
• second relapse who are sufficiently fit to undergo another round of intensive chemotherapy
• first relapse who per investigator discretion cannot tolerate additional anthracycline containing chemotherapy
• see link to clinicaltrials.gov for complete criteria
• participants with Down syndrome
• participants with Acute promyelocytic leukemia (APL) or Juvenile myelomonocytic leukemia (JMML)
• study staff will review additional exclusion criteria
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer (EMBER-4)
Disruption of estrogen signaling by drugs called selective estrogen receptor degraders (SERDs) is one of the treatment options for patients with estrogen receptor positive (ER+) cancers. Imlunestrant is a SERD that disrupts estrogen signaling, and therefore should stop or slow down tumor growth in ER+ cancers. This study will help answer research questions about the safety of imlunestrant and any side effects, and how imlunestrant compares to standard-of-care endocrine therapy.
• diagnosis of ER+, HER2- early-stage invasive breast cancer without evidence of distant metastasis
• completed surgery
• received at least 24 months but not more than 60 months of any endocrine therapy after treatment
• may be limited with strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• any evidence of metastatic disease
• more than a 6 month consecutive gap in therapy during the course of prior adjuvant endocrine therapy
• history of any other cancer
• women who are pregnant, breastfeeding, or expecting to conceive or men expecting to father children
MT2021-08: Phase II, Open-Label, Prospective Study of T Cell Receptor Alpha/Beta Depletion (A/B TCD) Peripheral Blood Stem Cell (PBSC) Transplantation for Children and Adults with Hematological Malignancies
The research aspect of this trial is the use of a new machine to remove specific lymphocytes from the donor’s peripheral blood stem cells (PBSCs). This is called T cell receptor alpha/beta T cell depletion. This machine does such a good job at removing the unwanted donor T cells, and as a result we think patients will need fewer drugs to suppress their immune system.
• hematological cancer needing stem cell transplant
• 60 years old or younger
• pregnant or breast feeding
• active infection
• positive for HIV, Hepatitis B or C
• brain metastasis
A Phase 1/2 Study of EG-70 as an Intravesical Administration to Patients with BCG-Unresponsive NMIBC
This study will evaluate the safety and tolerability of EG 70, a gene therapy, which is given inside the bladder. This study will measure its effectiveness on eliminating bladder tumors in participants with NMIBC who have failed or did not receive adequate Bacillus Calmette- Guérin (BCG) therapy. The study drug will be given into the lining of the bladder. This may cause an immune response inside the bladder and kill the cancer cells.
• BCG-unresponsive NMIBC with carcinoma in situ (CIS
• ineligible for or have elected not to undergo cystectomy
• women of childbearing potential must be willing to use highly effective birth control methods; Males are required to use a condom for the duration of the study treatment through 3 months post-dose
• at least walking and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion criteria
• other active cancer that required treatment in the past two years
• history of partial cystectomy
• history of severe asthma or other respiratory diseases
• human immunodeficiency virus, Hepatitis B, or Hepatitis C infection
• see link to clinicaltrials.gov for complete exclusion criteria
A Phase 2, Randomized, Human Growth Hormone-Controlled, Multicenter, Basket Study of Vosoritide in Children with Turner Syndrome, Short Stature Homeobox-Containing Gene Deficiency, and Noonan Syndrome with an Inadequate Response to Human Growth Hormone
This study is enrolling children with Turner syndrome, SHOX deficiency, or Noonan syndrome to evaluate the effect of 3 doses of a study drug, vosoritide, versus the standard of care human Growth Hormone (hGH). The study will look at growth over a 6 month period of time. The study will also look at how well the the study drug works (efficacy) and its safety at the therapeutic dose up until the child reaches their final adult height.
• Males >= 3 years old to < 11 years old
• Females >= 3 years old to < 10 years old
• Genetically confirmed diagnosis of Turner syndrome, SHOX deficiency or Noonan Sydrome
• Have been receiving continuous human growth hormone treatment of short stature associated with their condition for a minimum of 1 year
• Diagnosis of another systemic disease or condition that may cause short stature