Search Results
An International, Phase 3, Randomized, Multicenter, Open label Study of Ripretinib vs Sunitinib in Patients with Advanced Gastrointestinal Stromal Tumor (GIST) with KIT Exon 11 and Co occurring KIT Exons 17 and/or 18 Mutations Who Were Previously Treated with Imatinib (INSIGHT) (INSIGHT)
This study is being done to learn how well ripretinib works against cancer as compared to sunitinib in patients with a specific GIST-gene mutation who have received imatinib. We will also learn more about the safety of ripretinib and look at how ripretinib may affect your body. The choice of whether you will be given ripretinib or sunitinib will be assigned by a computer, by chance, like the flip of a coin. You will have a 2 out of 3 chances of receiving ripretinib. You will know if you are receiving ripretinib or sunitinib.
• diagnosis of GIST with co-occurring KIT exons 11+17/18 mutations confirmed by ctDNA sample
• disease progression on imatinib treatment, confirmed by scan
• ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• participants of reproductive potential must agree to follow contraception requirements
• contact study staff for additional inclusion criteria
• known active central nervous system metastases
• heart disease, myocardial infarction within 6 months of starting the study, active ischemia or any other uncontrolled cardiac condition such as angina, significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, or congestive heart failure
• Gastrointestinal abnormalities such as inability to take oral medication, malabsorption syndromes, requirement for intravenous alimentation
• additional exclusions apply malabsorption syndromes requirement for intravenous alimentation
Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry (IPF/ILD-PRO)
Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry is a prospective registry that will collect information regarding the natural history, health care interactions, participant reported questionnaire data to assess quality of life of IPF participants, and the methods of treatment of participants with a diagnosis of idiopathic pulmonary fibrosis (IPF) established at the enrolling centers. In addition, blood samples will be collected and banked for future research projects.
• at least 30 years old
• new diagnosis of Idiopathic Pulmonary Fibrosis (IPF) -diagnosis of a non-IPF Interstitial Lung Disease (ILD) of any duration, including, but not limited to Idiopathic Non-Specific Interstitial, Pneumonia (iNSIP), Unclassifiable Idiopathic Interstitial Pneumonias (IIPs), Interstitial Pneumonia with Autoimmune Features (IPAF), Autoimmune ILDs such as Rheumatoid Arthritis (RA-ILD) and Systemic Sclerosis (SSc-ILD), Chronic Hypersensitivity Pneumonitis (HP), Sarcoidosis or Exposure-related ILDs such as asbestosis
• Cancer, treated or untreated, other than skin or early stage prostate cancer, within the past 5 years
• currently waiting for lung transplantation
• currently enrolled in a clinical trial
Effects of Pallidal Deep Brain Stimulation Location on Motor Impairment in Parkinsons disease; Udall Project 2 Aims 1 & 2 Study
This protocol will characterize the effects of deep brain stimulation (DBS) location (both adverse and beneficial) on motor signs in people with Parkinson’s disease (PD). This information can be used to inform future DBS protocols to tailor stimulation to the specific needs of a patient. If targeted dorsal GP stimulation is shown to significantly improve motor features that are typically resistant to dopamine replacement therapy, these experiments will likely have major impact on clinical practice by providing a potential strategy to treat medically intractable symptoms.
• diagnosis of idiopathic Parkinson's Disease (PD)
• have a deep brain stimulator (DBS)
• have had a 7T brain scan
• history of musculoskeletal disorders that significantly affect movement of the upper or lower limbs
• other significant neurological disorder
• history of dementia or cognitive impairment
• post-operative complications or adverse effects of DBS
Stability 2: ACL Reconstruction +/- Lateral Tenodesis with Patellar vs Quad Tendon (Protocol # PRO19020231) (STABILITY 2)
The purpose of this multicenter study is to compare outcomes between patients who will undergo different types of ACL reconstruction. All patients will have a tendon from their own knee used to reconstruct the ACL. Prior to knee surgery, researchers will randomize (i.e. a coin toss) to determine if ACL reconstruction will be done with patellar or quadriceps tendon and if the lateral extra-articular tenodesis will or will not be added to the ACL surgery. We will follow-up with participants as they undergo treatment and recovery after surgery for 2 years.
• age 14-25
• ACL deficient knee
• at least two of the following: participate in a competitive pivoting sport; have a pivot shift of grade 2 or greater; have generalized ligamentous laxity
• previous ACL repair on either knee
• partial ACL tear
• multiple ligament injury (two or more ligaments requiring surgery)
• pregnancy
Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR System in patients with severe symptomatic mitral regurgitation – APOLLO Trial (APOLLO)
The purpose of this study is to determine if replacing the mitral valve without open-heart surgery is as safe and effective as standard mitral valve surgery in patients with similar medical conditions. This system allows a bioprosthetic mitral valve (investigational valve) to be implanted through a long, thin, flexible tube that is inserted through an incision in the side of the chest or through an incision made in the groin area and through a vein in the leg. Participation in the study is expected to last approximately 5 years from the day the valve is implanted.
• diagnosis of moderate or severe mitral value regurgitation with symptoms
• multidisciplinary heart team thinks patient is not able to have treatment an approved transcatheter repair or conventional mitral valve procedure
• prior transcatheter mitral valve procedure with device currently implanted
• left ventricular ejection fraction <30%
A Randomized Trial of Intra-Portal Alone Versus Intra- and Extra- Portal Transplantation of Pancreatic Islets After Total Pancreatectomy for Chronic Pancreatitis (iSite)
One treatment for certain types of chronic pancreatitis is total pancreatectomy with islet autotransplantation (TPIAT). In this procedure, the pancreas is removed (eliminating the source of the pain) and the islets, which produce insulin and other important hormones, are taken from the pancreas and transplanted in to the liver. This is a small study to evaluate a new procedure for transplanting some islets to a new location in the body.
• age 18- 68
• scheduled for a total pancreatectomy and IAT at University of Minnesota
• diabetes mellitus fasting blood glucose greater than 115mg/dl, or hemoglobin A1c level greater than 6.0%
• use of any of the following treatments in the 30 days prior to enrollment: insulin, metformin, sulfonylureas, glinides, thiazolidinediones, GLP-1 agonists, DPP-4 inhibitors, or amylin
• other medical or mental health diagnosis (study staff with review)
MT2023-33 A Phase II Study of Reduced Dose Post Transplantation; Cyclophosphamide as GvHD Prophylaxis in Adult Patients with Hematologic Malignancies Receiving HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation (OPTIMIZE)
Cyclophosphamide is a chemotherapy (chemo) drug often given after a transplant to prevent graft-versus-host disease (GvHD). We are doing this study to see if a lower dose of cyclophosphamide after transplant is as safe and works just as well. This study does not include any new or untested drugs. The drugs and procedures in this study are standard for people who receive a transplant.
• between 18 and 66 years old
• receiving an unrelated Donor Peripheral Blood Stem Cell Transplantation
• willing to comply with all study procedures and availability for the duration of the study
• see link to clinicaltrials.gov for complete Inclusion Criteria
• prior allogeneic transplant
• autologous transplant within the past 3 months
• women who are pregnant or breast feeding
• HIV+ with persistently positive viral load
• study staff will review
A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants with Advanced Cancer (TRIO049)
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer.
• advanced solid tumor
• restricted strenuous physical activity but can walk and able to carry light work e.g., light house work, office work
• progressive or symptomatic brain metastases
• serious, uncontrolled medical disorder or active, uncontrolled infection
• history of significant hear disease
• history of another cancer within 3 years
• women who are pregnant or breast feeding
• contact study staff for additional exclusion criteria
PRE-I-SPY TRIAL - PRE-Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis: A Phase I/Ib platform trial (I-SPY)
This study is intended to find the safest dose of a new combination of drugs (ALX148 and T-DXd) and to start to determine how effective it is at treating advanced or metastatic breast cancer. This study is an addition to the ongoing ISPY study program.
• have HER2+ breast cancer
• cancer has spread to other organs or returned within 6 months after first treatment
• active heart or liver disease
• cancer has spread to the brain and is causing current symptoms
MT2022-49: Early identification of cognitive side-effects of immunotherapy
This study is testing different ways to look for neurologic side effects in patients who get CAR-T therapy for their cancer.
• planning to have inpatient CAR-T therapy for primary cancer
• fluent in English (written or spoken)
• presence of speech or hearing problem
• diagnosis of cognitive impairment
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
Immune Modulation Associations With Urinary tract Infection In People With Neurogenic Bladder.
The goal of this study is to understand how urine and bladder tissue changes from infection, or a bladder that does not function normally, in people who use a catheter to empty their bladder. This may help future people because it can help determine who needs antibiotics to treat an infection in the bladder, and will help avoid the cost and side effects of using antibiotics in people who do not have a true infection. This study will take less than 1 hour – the time required to provide a urine sample in clinic. Or, if a participant is undergoing bladder Botox injection, the time necessary to participate in the study will add approximately 5 minutes to the total surgery time.
• at least 18 years old
• use clean intermittent catheterization (CIC) to empty the bladder
• without diagnosis of neurogenic bladder (NGB)
• OR NGB managed with bladder botulinum toxin injections with/without recurrent urinary tract infection (UTI) (may have an active UTI)
• presence of an indwelling catheter (i.e., Foley)
• history of bladder augmentation
• history of urinary diversion
• women who are pregnant
• non-English speaker
Advancing Liver Therapeutic Approaches (ALTA). The ALTA Consortium Study Group for the management of portal hypertension A 5-year longitudinal observational study of patients with cirrhosis undergoing TIPS placement
The goal of this study is to collect information about patients undergoing a TIPS and to evaluate the longterm outcomes and complications over a 5-year period. There are no expected direct benefits to participation in this study however knowledge gained from this research may beneficial to future patients undergoing this procedure. This study does not involve any investigational drugs.
• at least 18 years old
• scheduled to undergo a Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure
• women who are pregnant
• undergoing TIPS placement as part of an investigational study
MT2012-10C: Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune Deficiencies
The primary purpose of this study is to record outcomes and patient characteristics in the Cancer Center’s and BMT databases for patients who are undergoing an allogeneic (donor) hematopoietic stem cell transplant. The data will be analyzed for transplant “milestones” such as time to blood count recovery (engraftment) and how patients are doing at 3 months and 6 months after the transplant. Participation in this study will not alter treatment or medical care. All information for this study will be collected from medical records.
• up to 50 years old
• diagnosis of immunodeficiency or histiocytic disorder
• see link to clinicaltrials.gov for complete inclusion criteria
• pregnant or breastfeeding
• active, uncontrolled infection and/or HIV positive
• acute hepatitis or evidence of moderate or severe portal fibrosis or cirrhosis on biopsy
Physical Rehabilitation for Older Patients with Acute Heart Failure with Preserved Ejection Fraction (REHAB-HFpEF) (REHAB-HFpEF)
The purpose of this research study is to assess the effect of a physical rehabilitation program for people admitted to the hospital with a diagnosis of heart failure. After completing baseline tests, participants will be randomly assigned to one of two study groups. Randomization means that you are put into a group by chance. (It is like flipping a coin.) You will have an equal chance of being placed into either group. Participants are assigned to a rehabilitation intervention (treatment) group, or to the attention control group, that will receive usual care.
• at least 60 years old
• in the hospital for at least 24 hours to treat acute heart failure
• heart failure episode included symptoms getting worse and the need to add or increase drugs to treat it
• able to walk 4 meters (13 feet) with or without a cane or walker when the study starts
• discharge to an independent living situation
• acute heart attack in the past 3 months, or planned intervention in the next 6 months
• severe valve disease
• advanced kidney disease with dialysis planned in the next 6 months
• dementia
• already actively exercising at least 30 minutes at a time, twice a week for the past 6 weeks
A double-blind, randomized, placebo-controlled study to assess the safety and efficacy of nebulized PC945 when added to systemic antifungal therapy for the treatment of refractory invasive pulmonary aspergillosis
The purpose of this study is to learn about the safety and efficacy of PC945 when given in combination with the antifungal therapy that is normally given for this condition, also known as the standard of care (SoC). This study will also assess how PC945 is processed in the body (e.g., distributed, transformed, and removed) by measuring the levels of PC945 in your blood and lungs; this is called pharmacokinetics (PK).
• diagnosis of invasive pulmonary aspergillosis that hasn't responded to treatment
• surgical or medical condition that makes participation difficult or potentially unsafe
• require care in an intensive care unit
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction (PH-HFpEF); LEVEL: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF (LEVEL)
Levosimendan has not been approved by the FDA to treat people who have PH-HFpEF or approved to be taken by mouth (orally). In this study, we will measure the amount of levosimendan in blood at various times and evaluate the change in participants 6-Minute Walk Distance.
• 18 to 85 years old
• diagnosis of pulmonary arterial hypertension
• on stable doses of heart medication for at least 30 days
• there are specific requirements for birth control for women and men
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• ability to walk is limited by anything other than symptoms (shortness of breath and fatigue) related to pulmonary hypertension
• other diagnosis related to heart function such as valve disease, cardiomyopathy, etc.
• current lung disease
• study staff will review additional inclusion & exclusion criteria
An Open-label, Multicenter, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects with Previously Treated Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)
One goal of this study is to find out if enfortumab vedotin is effective and safe as a treatment for people with breast, lung, head and neck, gastric, gastroesophageal junction, or esophageal cancer. Researchers will look at how enfortumab vedotin can act in the body. Enfortumab vedotin is expected to work by attacking cells that have a protein called Nectin-4, commonly found in cancer cells. Another goal of this study is to find out if enfortumab vedotin is effective and safe when combined with another US Food and Drug Administration (FDA) approved medicine, pembrolizumab (brand name KEYTRUDA®), and used as a treatment for people with head and neck cancer who have not received previous chemotherapy treatment other than the chemotherapy that may have been given in combination with radiation therapy or right before or right after surgery in the past.
• locally advanced or metastatic disease of breast, lung, head and neck, gastric, gastroesophageal junction, or esophagus, that is not amenable to curative intent treatment
• evidence of progression on or after the last regimen received
• restricted strenuous activity but able to walk 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 cancer
• study staff will review
A prospective, randomized, controlled, blinded study to assess the Safety and Efficacy of the Butterfly Medical Prostatic Retraction Device in Benign Prostatic Hyperplasia (BPH) Patients.
The purpose of this study is to assess the safety and effectiveness of the Butterfly study device in reducing the symptoms that are associated with the BPH condition. Another purpose is to assess sexual function and quality of life following the use of the Butterfly study device. The Butterfly study device includes a metal (nitinol) implant that looks like a butterfly. The implant is inserted through the urethra - the tube that carries pee out of the body, and resides at the area of the prostate.
• men who are 50 to 80 years old
• symptomatic BPH
• additional criteria apply, study staff will review
• known sensitivity to Nickel
• current urinary retention
• urinary stress incontinence
• currently active bladder tumor or intravesical instillation
• additional exclusion criteria related to prostate or urinary tract function (study staff will review)
A Phase 3 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of BBP-418 (ribitol) in Patients with Limb Girdle Muscular Dystrophy 21 (LGMD21) (Fortify)
This study will use BBP-418 study drug in patients with LGMD to assess the clinical biomarkers, efficacy and safety of BBP-418 during the 36 months treatment phase.
• 12 to 60 years of age
• genetically confirmed diagnosis of limb girdle muscular dystrophy
• have clinical symptoms of weakness
• weight at least 30 kg (66 lbs.)
• willing to use a highly effective method of birth control until 12 weeks after last dose of study medication
• any significant medical or mental health diagnosis including abnormal lab values (study staff will review)
• surgery for scoliosis or other indication planned during the time of the study
• use of ribose or other sugar alcohol-containing supplement within 90 days of staring the study
• use of a systemic corticosteroid for the treatment of muscular dystrophy within 90 days of starting the study
Mechanisms of a Dynamic Stability Approach
If you have been referred to occupational therapy for thumb carpometacarpal osteoarthritis and you are 18 years or older, you are eligible for this study. Arthritis is the leading cause of disability in the United States, with an estimated 25.6 million Americans affected by osteoarthritis (OA) of the hand. Thumb carpometacarpal osteoarthritis (thumb carpometacarpal (CMC) joint osteoarthritis) is the most common and limiting form of hand osteoarthritis, causing chronic pain, weakness, reduced joint movement, and difficulty carrying out common daily tasks. The purpose of this research study is to find out if an 8-week dynamic stability program can help people with a range of CMC OA severity and symptoms. Dynamic stability (DS) is a new occupational therapy program that uses a series of exercises to strengthen specific muscles around the thumb CMC joint. By strengthening these muscles, the DS approach aims to reduce joint pain, delay further damage, and improve function and participation in daily activities. If you enroll, we expect that you will be in this research study for 9 weeks, for a total of about 15 hours of participation. During the study, you will participate in: 4 occupational therapy (OT) study visits (about 60 minutes each), a home exercise program (15-20 minutes/day) for 8 weeks and, 2 assessment visits (Baseline, and week 9) where we will using Computerized Tomography, a type of X-ray, and ultrasound to take measures of your affected joint and have you complete questionnaires related to pain and disability.
• Thumb Carpometacarpal (CMC) Osteoarthritis confirmed by xray
• referred to occupational therapy for treatment of thumb CMC osteoarthritis
• cortisone treatments to the affected thumb within the prior three months
• hand rehabilitation within the past six months
• thumb CMC joint replacement
• diagnosis of inflammatory arthritis
DORA Trial: Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
The purpose of this research is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy (at a lower dose) treatment versus using docetaxel alone (at the usual dose). The addition of radium-223 to docetaxel could be a better cancer treatment than just docetaxel alone, but it could also cause additional side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.
• at least 18 years old
• diagnosis of prostate cancer
• confirmed progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
• two or more bone lesions
• serum testosterone less than 50 ng/dL
• able to walk, carry out light work, and care for self independently
• received four or more systemic anticancer regimens for mCRPC (study staff will review) -received any prostate cancer chemotherapy for mCRPC
• any other serious illness or medical condition
NEPTUNE: The Nephrotic Syndrome Study Network - RDCRN Protocol 6801 (NEPTUNE)
Nephrotic syndrome is a condition which affects the kidneys causing them to leak protein from the blood into the urine. Nephrotic syndrome is a disease that can improve (remission) and worsen (relapse) at different times throughout childhood. By collecting health information and laboratory samples, our goal is to learn more about these kidney diseases and find better ways to prevent and treat people with nephrotic syndrome. New knowledge will be shared with researchers and the public.
• Group A: up to 80 years of age with clinical diagnosis for FSGS/MCD or MN or pediatric participants who have protein in the urine and are scheduled for a kidney biopsy
• Group B: are less than 19 years old, have started immunosuppression drugs less than 30 days ago and have abnormal kidney lab values
• prior solid organ transplant
• clinical diagnosis of glomerulopathy without diagnostic renal biopsy
• systemic lupus erythematosus (SLE)
• clinical evidence of other renal diseases
MT2020-28: Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids for Treatment of Minnesota High-Risk Acute GVHD (aGVHD): A Phase I/II Study
The purpose of this study is to learn whether the use of Pregnyl with the drug ruxolitinib is able to reduce the need for high dose steroids to treat severe acute Graft versus Host Disease (GVHD).
• Hematopoietic Cell Transplant (HCT) recipients over 12 years of age within the first 7 days of initial treatment of high-risk Acute-graft-versus-host Disease (aGVHD)
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• progressive cancer
• uncontrolled bacterial, fungal, parasitic, or viral infection
• current thromboembolic disease requiring full-dose anticoagulation
• active or recent (within prior 3 months) thrombus, irrespective of anticoagulation status
• pregnancy
• women or men of childbearing potential unwilling to take adequate precautions to avoid unintended pregnancy from the start of protocol treatment through 30 days after the last treatment
A randomized phase II trial of adjuvant Pembrolizumab versus observation following curative resection for stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm: Big Ten Cancer Research Consortium BTCRC-LUN18-153
This is a research study to find out if giving a drug called pembrolizumab after lung cancer surgery does a better job at keeping the cancer from coming back than surgery alone.
• at least 18 years old
• diagnosis of non-small cell lung cancer (NSCLC)
• tumor size between 1 and 4 cm in size
• had a complete surgical resection of stage I NSCLC between 4-12 weeks ago
• able to walk and carry out basic activities of living
• women are willing to use highly effective birth control for 120 days after last dose of study drug
• certain laboratory values are required (study staff will review)
• chemotherapy, radiation therapy, or immunotherapy for the treatment of this lung cancer
• active additional cancer that is progressing or has required treatment within the past 3 years
• diagnosis of immunodeficiency or receiving chronic steroid therapy
• women who are pregnant or breast feeding
• other active diseases (study staff will review)
Quality of life in patients who have undergone different treatments for upper airway stenosis
The objective of the study is to define quality of life in patients with upper airway stenosis after bypassing the stenosis with either tracheotomy or t-tube stenting. Participants complete surveys over 2 years to collect quality of life information.
• diagnosis of upper airway stenosis treated with tracheotomy or t-tube.
• seen at the Lions Voice Clinic
• at least 18 years old
• able to complete questionnaires in English without help
• require mechanical ventilation
• neurological conditions such as stroke, cerebral palsy, neurodegenerative disease.
• new diagnosis (less than 1 year) of head and neck cancer as the indication for tracheotomy
MT2020-27: Phase I/II Trial Using E7777 to Enhance Regulatory T-Cell Depletion Prior to Tisagenlecleucel (Kymriah) Therapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
This purpose of this study is to identify a safe dose level for the study drug, E7777, when given with standard tisagenlecleucel therapy (also known by its brand name, Kymriah, is an immunotherapy that is made from the participants own blood cells) in participants with Diffuse Large B-Cell Lymphoma (DLBCL). Up to three dose levels of E7777 will be tested.
• diagnosis of a relapse or refractory large B cell lymphoma, for which treatment with Kymriah is planned
• received two or more lines of systemic therapy
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• participants of child bearing age must use birth control for 30 days following completion of treatment
• additional inclusion criteria (study staff will review)
• women who are pregnant or breast feeding
• CNS involvement by malignancy
• eye disease or complaints visual acuity impairment, color or shape distortion, or blurred vision - potential participants are required to have an eye exam as part of screening
• additional exclusion criteria (study staff will review)
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
• 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
Randomized Clinical Evaluation of the AccuCinch Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF)
The objective of this study is to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with symptomatic heart failure with reduced ejection fraction (HFrEF).
• at least 18 years old
• Ejection Fraction: between 20% and 40% measured by transthoracic echocardiography (TTE)
• diagnosis and treatment for heart failure should be established at least 90 days before entering the study & should be on stable, optimal medical therapy for at least 30 days
• myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 90 days prior to consent
• any planned cardiac surgery or interventions within the next 180 days
• women who are pregnant, planning to become pregnant, or are breast feeding
• additional cardiac and medical diagnosis will exclude participation (study staff will review)
MT2022-44 Analysis of Autoinflammation in Chronic Granulomatous Disease Patients Undergoing Hematopoietic Cell Transplantation or Gene Therapy (PIDTC 6908)
CGD disorders are a group of diseases that cause the immune system to function abnormally, leading to infections, autoimmunity and/or inflammation that can begin early in life. CGD is usually caused by changes in certain genes in DNA. Researchers are trying to learn what types of medical problems patients with CGD have and how these respond to treatment, including bone marrow transplantation and gene therapy. Researchers also want to learn which genes cause CGD and how specific gene abnormalities lead to medical problems.
• confirmed diagnosis of Chronic Granulomatous Disease (CGD)
• to be scheduled to undergo HCT or GT within one year of enrollment
• additional inclusion criteria (study staff will review)
• .presence of other primary immunodeficiency syndromes that do not meet the clinical and laboratory criteria for CGD
• HIV infection
• past or current medical problems or findings from physical examination or laboratory testing that are not listed above which, in the opinion of the investigator, may pose additional risks from participation