Search Results
A US Phase 3b, Multi-center, Randomized, Double-blind, Double-Dummy Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults with Chronic Spontaneous Urticaria Inadequately Controlled bySecond Generation H1-Antihistamines (RECLAIM)
The purpose of this study is to evaluate the efficacy of remibrutinib in comparison to dupilumab. We want to see which one works better for helping adults who have chronic spontaneous urticaria (CSU) and haven't had relief with use of second-generation antihistamines in treating adult participants who have CSU.
• diagnosis of Urticaria
• prior use of remibrutinib, dupilumab or other BTK inhibitors
Effects of ziltivekimab versus placebo on morbidity and mortality in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation. (HERMES)
We are looking at a new drug called 'ziltivekimab' to see if it can be used to treat people living with heart failure and inflammation. People will get either ziltivekimab or a placebo (inactive dummy drug). The study drug is an injection given into the fold of the skin on the stomach, thigh or upper arm once every month. People will take the study drug for up to 4 years.
• at least 18 years old
• diagnosis of heart failure
• hospitalization or urgent/unplanned visit with a primary diagnosis of decompensated heart failure which required intravenous diuretic treatment, within the last 9 months prior to starting the study
• left ventricular ejection fraction (LVEF) greater than 40% documented by echocardiogram in the past year
• contact study staff for additional requirements
• myocardial infarction, stroke, unstable angina pectoris, transient ischemic attack, or heart failure hospitalization within 30 days
• planned cardiac procedures (ablation, revascularization
• primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD etc.)
• women who are pregnant, breast-feeding or planning to get pregnant during the study period.
• contact study staff for additional exclusion criteria
A Randomized Phase II Study Comparing Sequential High dose Testosterone and Enzalutamide to Enzalutamide alone in Asymptomatic Men with Castration Resistant Metastatic Prostate Cancer
The goal of this current study is to test whether men with prostate cancer that is getting worse after treatment with hormone therapy and abiraterone respond better to alternating treatment with testosterone and enzalutamide vs. enzalutamide alone. We are testing to see which is better at stopping tumor growth that can be seen on a bone scan or CT scan and the effect of each regimen on lowering Prostate Specific Antigen (PSA values). Participants will be in the study for 6 to 24 months.
• diagnosis of adenocarcinoma of the prostate
• spread (metastatic) to other organs or bone
• one chemotherapy treatment for hormone sensitive prostate cancer is allowed
• previous treatment required, study staff will review
• able to care for self with little help
• prior chemotherapy with docetaxel or cabazitaxel for CRPC
• other severe medical conditions, study staff will review
Protocol M23-716: A Phase 3 randomized, placebo-controlled, double-blind program to evaluate efficacy and safety of upadacitinib in adult and adolescent subjects with severe alopecia areata
This study will assess how effective and safe the use of the medication named Upadacitinib is for the treatment of signs and symptoms of severe hair loss in adults.
• 12-63 years of age
• have more than 50% hair loss
• pregnancy
A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination with the CDK4/6 Inhibitor Ribociclib, with the PI3K Inhibitor Alpelisib, or with the mTOR inhibitor Everolimus in Adult Subjects with Advanced and/or Metastatic ER Positive, HER2 Negative Breast Cancer
The main purpose of this study is to look at how safe and well tolerated the study drug is in combination with ribociclib (Group 1) or alpelisib (Group 2), the levels of the study drug and ribociclib or alpelisib in your blood, and how your body and your cancer respond.
• at least 18 years old
• diagnosis of advanced and/or Metastatic HR Positive, HER2 Negative Breast Cancer
• received no more than 2 prior hormonal regimens for advanced or metastatic disease
• received no more than 1 prior chemotherapy for locally advanced or metastatic breast cancer
• significant heart disease
• cerebral vascular disease within 6 months
• pulmonary embolism, or deep venous thrombosis within the last 6 months
• pneumonitis or interstitial lung disease
• history or ongoing gastrointestinal disorders that result in poor absorption of medications
• history of significant liver disease
• study staff will review medical history
Investigation of a Novel, magNetically levitated VAD for the treatment of refractOry left Ventricular heArT failurE (INNOVATE Trial) (INNOVATE)
The study is to evaluate the safety and effectiveness of the investigational BrioVAD® System compared to the commercially available HeartMate 3™ LVAS. Both the BrioVAD System and the HeartMate 3 LVAS are left ventricular assist devices (LVAD) that help pump blood from the lower left chamber of the heart to the rest of the body. An LVAD is used to treat weakened hearts or heart failure and may be a temporary measure while waiting for a heart transplant or a permanent solution.
• has received institutional approval for Left Ventricular Assist Device (LVAD) implantation
• advanced heart failure refractory to advanced heart failure management or NYHA Class III with experience shortness of breath with mild physical activity
• left ventricular ejection fraction (LVEF) ≤ 25%
• women of childbearing age agree to use adequate contraception and have a negative pregnancy test
• see link to clinicaltrials.gov for complete inclusion criteria
• had cardiothoracic surgery within 30 days of implant
• unable to have warfarin anticoagulation
• history of organ transplantation
• see link to clinicaltrials.gov for complete exclusion criteria
AALL2321; A Phase 2 Study of Blinatumomab in Combination with Chemotherapy for Infants with Newly Diagnosed Acute Lymphoblastic Leukemia with Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax
To evaluate the addition of two cycles of blinatumomab for all infants with newly diagnosed ALL and will evaluate in a randomized manner the safety, tolerability, and early activity of venetoclax in infants with KMT2A-R ALL.
• Eligibility Screening: All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to treatment and enrollment on AALL2321.
• Age: Infants (aged 365 days or less) on the date of diagnosis are eligible; infants must be > 36 weeks gestational age at the time of enrollment.
• Diagnosis: Patients must have newly diagnosed B-acute lymphoblastic leukemia (B-ALL, 2017 WHO classification), also termed B-precursor ALL, or acute leukemia of ambiguous lineage (ALAL), which includes mixed phenotype acute leukemia. For patients with ALAL, the immunophenotype of the leukemia must comprise at least 50% B lineage.
• Patients with Down Syndrome.
• Patients with secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy.
• Prior therapy: Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of infant ALL or for any cancer diagnosis prior to the initiation of protocol therapy.
Individualized Diabetes Education Assisted by CGM (IDEA-CGM)
This study aims to learn more about how continuous glucose monitor (CGM) data can be used to personalize lifestyle interventions for type 2 diabetes. Participation in the study would require 4-5 clinic visits over a period of 14 weeks. Participants will also be asked to: meet with study staff every 2 weeks (virtually), keep food logs, periodically wear an activity monitor and/or a CGM, answer survey questions, and provide blood samples to measure markers of diabetes control (like hemoglobin A1c).
• At least 18 years of age
• Diagnosis of type 2 diabetes mellitus
• Hemoglobin A1c of 6.8 – 8.5 %
• Stable medications for diabetes for at least 3 months prior to enrollment, with no plans to change medications or doses during the intervention period
• Type 1 diabetes mellitus
• Treatment with insulin, sulfonylurea, or meglitinide
• Use of a non-diabetes medication affecting blood glucose (e.g. corticosteroid)
• BMI < 25 kg/m2, or <23 kg/m2 for participants who self-identify as Asian
• Weight change > 5 pounds in the 3 months prior to study enrollment
• Estimated glomerular filtration rate <60 ml/minute/1.73 m2
• Pregnant or breastfeeding
• Anemia
• Changes to diabetes medications, including change in dose, in the 3 months prior to enrollment
• Presence of any disease that would make adherence to the protocol difficult
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
MT2020-08 A Phase 1/1b Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and Clinical Activity of PBCAR0191(azercabtagene zapreleucel or azer-cel), in Subjects with Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)
The purpose of this research study is to obtain information on the safety and effectiveness of PBCAR0191 to treat certain types of cancers, such as Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia. It is made from a type of blood cells known as T cells. The T cells in PBCAR0191 came from people who have donated their blood. The donated T cells have been genetically changed, so that they may be able to kill specific cancer cells commonly present in Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia.
• diagnosis of Non-Hodgkin Lymphoma
• received at least 2, but no more than 7 prior chemotherapy-containing treatment regimens
• previously treated with CD19-directed autologous CAR T therapies have received no more than 2 lines of therapy after administration of their previous CAR T product
• restricted in strenuous activity but able to walk and able to carry out light work e.g., light house work, office work
• adequate bone marrow, renal, hepatic, pulmonary, and cardiac function (study staff will review)
• prior or active CNS disease
• uncontrolled and serious fungal, bacterial, viral, protozoal, or other infection
• active hepatitis B or hepatitis C
• any known uncontrolled cardiovascular disease
• contact study staff for additional exclusion criteria
DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: a breast cancer prevention pilot study
The trial offers women with ductal cell carcinoma in situ (DCIS) 6 months of neoadjuvant exposure to endocrine therapy with the intent of determining their suitability for long-term active surveillance without surgery.
• diagnosis of HR+ DCIS (at least 50% ER or PR (from biopsy at diagnosis) with or without microinvasion
• may have received endocrine therapy
• see link to clinicaltrials.gov for complete Inclusion criteria
• women who are pregnant or breast feeding
• breast cancer is invasive
• unable to swallow tablets or capsules
• gastrointestinal conditions that would interfere with absorption of medication -- see link to clinical trials.gov for complete Exclusion criteria
A Phase 1/2 Study of FOG-001 in Participants with Locally Advanced or Metastatic Solid Tumors (FOG-001-101)
This study is for people who have been diagnosed with cancer that is advanced (means disease has spread from the original site or has come back) or is metastatic (means the disease has spread to other parts of the body). FOG-001 is currently being developed to treat people with cancer. We want see how safe and tolerable FOG-001 is when given alone and together with other anticancer drugs at different dose levels in participants. We also want to see how FOG-001 affects the body and the cancer
• locally advanced or metastatic solid tumor
• may not be able to do physically strenuous activity but walking and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for specific requirements by type of tumor
• history of bone metastasis except patients with mCRPC
• Osteoporosis
• uncontrolled inflammatory bowel disease (i.e., ulcerative colitis or Crohn's disease)
• women who are pregnant, breastfeeding, or planning to be come pregnant
• see link to clinicaltrials.gov for complete Exclusion criteria
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)
A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination with Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination with Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (COPERNICUS)
This study is being conducted to compare the efficacy of subcutaneous amivantamab plus lazertinib in previously untreated EGFR mutated non-small cell lung cancer OR subcutaneous amivantamab plus chemotherapy after having received prior therapy for EGFR mutated non-small cell lung cancer.
• new diagnosis of non-small cell lung cancer (NSCLC) OR metastatic (in other areas of the body) or is too advanced for treatment that will cure the cancer
• tumor has an epidermal growth factor receptor gene (EGFR) mutation
• able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work, but can't do strenuous physical activity
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• history of active interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
• not have fully recovered from surgery, or has surgery planned during the time the participant is expected to be in the study
• uncontrolled tumor-related pain
MT2023-20: Hematopoietic cell transplant with reduced intensity conditioning and post-transplant cyclophosphamide for severe aplastic anemia and other forms of acquired bone marrow failure.
Although allogeneic hematopoietic cell transplant (HCT) is standard treatment for severe aplastic anemia, the use of the lower intensity conditioning drugs with a personalized dosing strategy, low dose total body irradiation (TBI) with dosing based on age and bone marrow abnormalities, and use of the drug cyclophosphamide early after transplant is a newer approach. We are studying whether this new approach is safer and more effective than our previous approach.
• 0 to 75 years old
• diagnosis of Idiopathic Severe Aplastic Anemia (SAA)
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• women who are pregnant, breastfeeding or intending to become pregnant during the study
• uncontrolled infection
At-home Ultrasound Localized Therapy for Rheumatoid Arthritis Study (At-home ULTRA)
The research objective is to evaluate performance of ultrasound stimulation of the spleen for the treatment of rheumatoid arthritis (RA). In particular, a new wearable ultrasound device has been developed for anti-inflammatory treatment by a company called SecondWave Systems. We will measure RA disease activity, biomarkers and clinical metrics for up to 24 weeks of investigational ultrasound treatment.
• active moderate to severe seropositive rheumatoid arthritis (RA)
• have at least 6 total tender and/or swollen joints
• receiving stable background treatment with a csDMARD (e.g. methotrexate) for at least 8 weeks prior to start of the study. Participants must be willing to maintain their background medication regimen throughout the 28-week study period
• may receive up to 10 mg of daily prednisone as part of treatment but must have maintained a stable dose for a minimum of 6 weeks prior to start of the study and be willing to maintain the stable dose until after the Week 24 of the study
• see link to clinicaltrials.gov for complete Inclusion criteria
• women who are pregnant or trying to get pregnant
• active bacterial or viral infection
• implanted device or other solid object on the spleen side of the torso
• recent abdominal surgery
• see link to clinicaltrials.gov for complete Exclusion criteria
HM2024-28: A Pilot Study to Investigate the Clinical Utility of Tremoflo Airway Oscillometry in the Pediatric and Adolescent Population with Pulmonary Pathology or at Risk of Lung Injury
The purpose of this study is to help investigators learn more about what are the best methods for diagnosing and monitoring lung problems.
• age 0 to 24
• physician thinks patient might benefit from early and more frequent pulmonary function monitoring
• at risk for developing lung disease
• unlikely to complete required study components
MT2025-13 Long-term Follow-up of Subjects Who Received TRX103 in a Clinical Study Sponsored by Tr1X, Inc
This study will enroll people who receive TRX103 as part of a separate research study, in order to monitor these patients for long-term safety, and discover more about the long-term effects of TRX103.
• have received TRX103 in a clinical study and have either completed the study or have discontinued early from the study
• withdrawal from a clinical study before infusion of TRX103
State Representation in Early Psychosis 2
In this study, participants will complete two to three appointments within two weeks. During these appointments, they will complete interviews and questionnaires about their life experiences and mental health. An EEG test will also be conducted while they complete computerized tasks. We are recruiting two groups of participants for this study. One group will include individuals who experience hallucinations, delusions, paranoia, or a psychosis spectrum disorder (i.e., schizophrenia), and the other group will be individuals who do not have a diagnosis or family history of schizophrenia, bipolar disorder, or autism spectrum disorder.
• 15 to 45 years old
• able to speak and write English
• no hospitalizations and on stable doses of medications for the past one month or more
• diagnosis of schizophrenia, schizoaffective disorder, psychosis, bipolar disorder with psychosis, or major depressive disorder with psychosis
• matched healthy volunteers
• previous clinically significant head injury
• severe substance or alcohol use within past 3 months - major neurological disorder - medical condition that would interfere with participation
• currently at risk for suicidal behavior
MT2023-30: A Phase 1 Study of FT825/ONO-8250, an Off-the-Shelf CAR T-Cell Therapy, With or Without Monoclonal Antibodies, in HER2-Positive or Other Advanced Solid Tumors
The purpose of this study is to test the safety of FT825 at different doses and to understand the way the body processes and responds to FT825. The study will also find out what effects FT825, when given with or without a monoclonal antibody (cetuximab) and different chemotherapy regimens, have on cancer. FT825 is a type of cell product made up of “T cells.” T cells are part of your immune system and are important in helping fight infections. T cells are also important in eliminating cancer cells.
• diagnosis locally advanced or metastatic cancer
• cancer that is not amenable to curative therapy, with prior therapies defined by specific tumor types
• restricted from 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
• women who are pregnant or breastfeeding
• active central nervous system (CNS) involvement by cancer -active bacterial, fungal, or viral infections
• additional exclusion criteria (study staff will review)
PEPN2111 - A Phase 1/2 Trial of CBL0137 (NSC# 825802, IND# 155843) in Patients with Relapsed or Refractory Solid Tumors including CNS Tumors and Lymphoma
A Phase I/II trial of single agent intravenous CBL0137 in pediatric patients (≥ 12 months and ≤ 30 years) with relapsed/refractory solid tumors, including CNS tumors and lymphoma.
• 12 months to 30 years old
• patients with relapsed or refractory solid tumors or lymphoma, including patients with CNS tumors or known CNS metastases, or patients with progressive or recurrent DIPG (diagnosed by biopsy or imaging characteristics) and other H3 K27M-mutant diffuse midline gliomas previously treated with radiation therapy, or patients with relapsed or refractory osteosarcoma
• patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment
• patients have consented to receive a central venous catheter prior to the administration of CBL0137
• see link to clnicaltrials.gov for complete inclusion and exclusion criteria
• pregnant or breast-feeding women
• patients who have an uncontrolled infection
• patients who have received a prior solid organ transplantation
Satisfaction and usability assessment of a take-home device for tinnitus
This study is about assessing compliance, satisfaction, and usability of a take-home device for tinnitus management, specifically a bimodal neuromodulation device using customized acoustic stimulation paired with electrical ear stimulation. This study also examines whether integrative health (IH) practices – such as deep breathing – paired with bimodal neuromodulation can enhance long-term plasticity of the brain and reduce stress.
• Subjective tinnitus (only you can hear your tinnitus)
• tinnitus has a dominant pitch
• willing to commit to a 18-week study
• Objective tinnitus (other people can hear your tinnitus too)
• users of hearing aids or cochlear implants, or an electro-active implanted device
A Phase 3 Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy (OMAHA-003) (OMAHA-003)
This trial is testing MK-5684 in men with metastatic castration-resistant prostate cancer (mCRPC) previously treated with next-generation Hormonal Agent (NHA) and Taxane-based chemotherapy. This trial will compare MK-5684 to abiraterone acetate and enzalutamide. Abiraterone acetate and enzalutamide are standard treatments for mCRPC. The purpose of this trial is to test the safety of the trial drug, MK-5684, see how well the drug works, and see how the body handles the drug. We also want to see if participants who get MK-5684 live longer compared to those who get abiraterone acetate or enzalutamide.
• diagnosis of adenocarcinoma of the prostate
• cancer progression while on androgen deprivation therapy with metastasis to bone or other areas of the body
• received 1 but no more than 2 taxane-based chemotherapy regimens
• unable to do strenuous activity but walking and able to 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
• unable to swallow capsules/tablets
• gastrointestinal disorder that might affect absorption
• poorly controlled diabetes mellitus
• history of clinically significant ventricular arrhythmias
• known additional cancer that is progressing or has required active treatment within the past 3 years
A Pivotal Study Evaluating Safety and Efficacy of the ShiraTronics Migraine Therapy System in RELIEVing, Interrupting, and Preventing Chronic Migraine (RELIEV-CM2)
This research study is testing a potential new treatment for refractory chronic migraine (RCM). The potential new treatment is called ShiraTronics Migraine Therapy. The purpose of this study is to demonstrate the safety and effectiveness of the ShiraTronics Migraine Therapy System. The ShiraTronics System delivers mild electrical pulses to nerves associated with migraine pain around the back and front of your head. These electrical pulses interrupt or change the transmission of pain signals to the brain, which can potentially relieve your chronic migraine pain and symptoms. The ShiraTronics System is approved by the United States Food and Drug Administration for investigational (under research) use, and not approved for sale.
• at least 22 years old
• migraines started before 50 years old
• migraines occurring for at least 12 months before starting the study
• 15 - 26 headache days/month, among which ≥ 8 days has the features of probable migraine, and minimum of 2 headache-free days/month
• use of preventive(s) migraine medication for at least 3 months before starting the study
• headache or migraine other than refractory chronic migraine (RCM)
• previously implanted neurostimulator
• received botulinumtoxinA (Botox) for any other medical or cosmetic reasons requiring injections in the head, face, or neck within the past 3 months
• cervical radiofrequency ablation within 12 months
• other implanted electrical stimulation device or any metallic implant located in the head including CSF shunt and surgical clip above the shoulder line (excluding dental implants)
• women who are pregnant or breastfeeding or planning a pregnancy during participation in the study
A Phase 3, Open label, Uncontrolled Single-arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Avacopan in Combination With a Rituximab or Cyclophosphamide-containing Regimen in Children from 6 Years to less than 18 Years of Age with Active ANCA-associated Vasculitis (AAV)
Blood vessel inflammation can damage parts of the body. The medicines we use to treat AAV try to turn off the blood vessel inflammation to prevent damage to the body. The purpose of this study is to see how safe and how well a medicine called avacopan works when combined with a child’s regular medicine used to treat their AAV. This medicine is not approved in children, so will be called a “study drug.”
• 6 to 17 years old
• diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)
• newly diagnosed or relapsed AAV with positive test for anti-PR3 or anti-MPO antibodies
• weigh at least 15 kg (33 lbs)
• any other known multisystem autoimmune disease
• any medical condition requiring or expected to require continued use of immunosuppressive treatments, including corticosteroids
MT2022-52: Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning (RIC) with Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases
Stem cell transplants (sometimes referred to as a bone marrow transplants) have been done for over 40 years but research continues to further refine the method to reduce side effects without affecting transplant success. The purpose of this study is to improve on transplant outcomes while reducing the potential side effects based on what has been learned from previous transplant studies using a reduced intensity preparative regimen. Information collected during this study (transplant outcomes and side effects) will be compared with the outcomes of the previous reduced intensity conditioning transplant study that enrolled more than 300 patients since 2002.
• up to 75 years of age
• have a matched related donor
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• women who are pregnant or breast feeding
• active central nervous system malignancy
• untreated active infection
• additional criteria for exclusion (study staff will review)
Phase I Study of Peptide Alarm Therapy (PAT) Administered by Intratumoral Injection with a PD-1/PD-L1 Inhibitor in Patients with Solid Tumor Cancers Who Have Failed Two Prior Therapies
This study is testing an “investigational” drug referred to as peptide alarm therapy (PAT) that was specially made for this study. PAT is using the peptide to stimulate the immune system for people who have failed prior treatment with a PD-1/PD-L1 inhibitor. Examples of PD-1/PD-L1 inhibitors are pembrolizumab (Keytruda), nivolumab (Opdivo), cemiplimab (Libtayo), atezolizumab (Tecentriq), avelumab (Bavencio), and durvalumab (Imfinzi). The goal of the 1st part of the study is to identify an acceptable, safe dose of PAT and up to 3 dose levels of PAT will be tested. If dose level 3 is reached without toxicity, it becomes the dose used for the next part of the study. In the 2nd part of the study, additional patients are treated at the PAT dose identified as safe in the 1st part to gain additional safety information and provide an initial estimate of anti-cancer effect.
• positive for Cytomegalovirus (CMV) and Epstein–Barr virus (EBV
• failed prior treatment with a PD-1/PD-L1 inhibitor. Examples of PD-1/PD-L1 inhibitors are pembrolizumab (Keytruda), nivolumab (Opdivo), cemiplimab (Libtayo), atezolizumab (Tecentriq), avelumab (Bavencio), and durvalumab (Imfinzi).
• strenuous activity may be restricted; can do light work; able to walk
• people of childbearing potential or with partners of childbearing potential must be willing to abstain from heterosexual activity or use a highly effect form of contraception from the time of study enrollment until at least 4 months after the last dose study drug
• see link to clinicaltrials.gov for complete Inclusion criteria
• women who are pregnant or breast feeding
• active metastases to the central nervous system
• active autoimmune disease that has required systemic treatment in the past 2 years
• history of bone marrow and/or solid organ transplant
• other active medical conditions
• see link to clinicaltrials.gov for complete Exclusion criteria
Closed Loop and Education for hypoglycemia Awareness Restoration (CLEAR) (CLEAR)
The purpose of this study is to learn how to improve hypoglycemia unawareness - a condition where people with Type 1 Diabetes may not be able to tell how low their blood sugar levels are. This study will use different types of education and devices to see if they can help people become more aware when the blood sugar is low.
• 18 to 75 years old
• diagnosis of type 1 diabetes
• sometimes struggle to feel symptoms of low blood sugar
• have had diabetes for at least 10 years
• A1c no more than 10.5%
• able to read and speak English (because non-English versions of the tests and the educational materials are not available)
• see link to clinicaltrials.gov for complete Inclusion criteria
• medical conditions that limit participation in study activities, as determined by the physician (including but not limited to cognitive dysfunction, reduced hearing, reduced vision, cancer under active treatment, untreated angina, organ failure)
• active alcohol or drug abuse
• seizure disorder unrelated to hypoglycemia, unless seizure-free for at 12 months and on stable therapy
• medical condition that requires intermittent or continuous use of glucocorticoids
• women who are pregnant, planning to become pregnant or are breastfeeding
• hospitalized for mental illness in last year
• see link to clinicaltrials.gov for complete Exclusion criteria
A double blind, randomised, placebo-controlled trial evaluating the efficacy and safety of nerandomilast over at least 26 weeks in patients with Systemic Autoimmune Rheumatic Diseases associated Interstitial Lung Diseases (SARD-ILD)
Nerandomilast is being developed to treat lung fibrosis. This study is to test a drug called nerandomilast in people with SARD-ILD who also take an immunosuppressant medicine. Participants are put into 2 groups randomly, which means by chance and will receive either nerandomilast or placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any study drug. Participants will be in the study for about 7.5 to 13 months depending on when they join the study.
• diagnosis of systemic autoimmune rheumatic diseases associated interstitial lung diseases (SARD-ILD)
• lung function has not improved with immunosuppressant (IS) therapy
• see link to clinicaltrials.gov for complete Inclusion criteria
• active vasculitis
• suicidal behavior in the past 2 years
• see link to clinicaltrials.gov for complete Exclusion criteria
A PHASE III TRIAL OF ONE VS. TWO YEARS OF MAINTENANCE OLAPARIB, WITH OR WITHOUT BEVACIZUMAB, IN PATIENTS WITH BRCA1/2 MUTATED OR HOMOLOGOUS RECOMBINATION DEFICIENT (HRD+) OVARIAN CANCER FOLLOWING RESPONSE TO FIRST LINE PLATINUM-BASED CHEMOTHERAPY
The usual approach for patients who are not in a study is treatment of ovarian cancer with surgery, radiation, or U.S. Food and Drug Administration (FDA)-approved drugs. Sometimes, combinations of these treatments are used. We are doing this study because we want to find out if the use of Olaparib for one year is as good or worse than the usual approach for ovarian tumor.
• newly diagnosed, confirmed stage III or IV ovarian cancer of the following types: high grade serous or endometrioid, or other epithelial ovarian cancer with BRCA1/2 alteration
• ovarian cancer includes ovarian, fallopian, or primary peritoneal cancer
• must have had cytoreductive surgery
• must have completed first line platinum-based therapy before starting the study (no more than 12 weeks prior)
• not pregnant or breastfeeding
• see link to clinicaltrials.gov for complete inclusion criteria