Search Results
MT2026-02: A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (Dara-VCD) Induction Followed by Autologous Stem Cell Transplant or Dara-VCD Consolidation and Daratumumab Maintenance in Patients with Newly Diagnosed AL Amyloidosis (SWOG S2213)
The purpose of this study is to compare two treatment approaches for people with amyloidosis: daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-VCD) chemotherapy followed by an autologous stem cell transplant versus Dara-VCD followed by daratumumab maintenance therapy without a stem cell transplant.
• diagnosis of systemic amyloid light chain (AL) amyloidosis
• may receive up to one cycle (or 28 days) of therapy prior to starting the study
• may be receiving chronic corticosteroids if they are being given for other disorders
• must be willing to undergo high dose chemotherapy and autologous stem cell transplantation
• see link to clinicaltrials.gov for complete inclusion criteria
• women who are pregnant or breastfeeding
• other uncontrolled illnesses including diabetes, hypertension, heart or lung disease
• see link to clinicaltrials.gov for complete exclusion criteria
MT2025-20: A Phase II, multi-part, five-year, randomized, open-label, assessor-blinded, active-controlled, multicenter study to evaluate the efficacy and safety of rapcabtagene autoleucel versus rituximab treatment in participants with severe refractory diffuse cutaneous systemic sclerosis
The goal of this study is to find out if the experimental drug rapcabtagene autoleucel (herein referred to as YTB323), an investigational new therapy, is safe and effective (can help) for people who have severe refractory diffuse cutaneous systemic sclerosis (dcSSc). YTB323 is a chimeric antigen receptor T cell (CAR-T cell) therapy, which is a type of gene therapy or immunotherapy. CAR-T involves collecting and using a patient’s own immune cells, specifically their T cells, to treat their condition.
• 18 to 70 years old
• diagnosis of systemic sclerosis and meet the criteria for diffuse cutaneous (dcSSc)
• Disease onset from the first symptoms attributable to SSc (e.g., puffy hands, scleroderma, digital ulcers, arthralgia, dyspnea) within past 7 years
• severe, progressive systemic sclerosis disease
• see link to clinicaltrials.gov for complete Inclusion criteria
• Rheumatic disease other than dcSSc
• pulmonary hypertension
• significant kidney disease
• uncontrolled hypertension
• see link to clinicaltrials.gov for complete Exclusion criteria
Phase I Clinical Trial of iPSC-Based Therapy (MyoPAXon) for Muscular Dystrophy
This study aims to find out whether MyoPAXon, a genetically modified cellular therapy treatment, is safe to give to patients with Duchenne Muscular Dystrophy (DMD), and whether it has any positive effect on their disease. It will also determine how much MyoPAXon is safe to give to a person at one time.
• diagnosed with Duchenne muscular dystrophy (DMD) and non-ambulatory
• age 18 or older
• off investigational treatments for at least 30 days
• presence of HLA antibodies directed toward HLA antigens on MyoPAXon
• active treatment with another investigational therapy
• known allergy to MyoPAXon components
COG APEC14B1 The Project: Every Child Protocol: A Registry, Eligibility Screening, Biology and Outcome Study Additional Title: EVERYCHILD (APEC14B1) PCR - COG Foundation
This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.
• must be =< 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network [NCTN]) therapeutic study, for which there is a higher upper age limit
• patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations
• enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy
• see link to clinicaltrials.gov for additional inclusion criteria
A pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) who are receiving an angiotensin II receptor blocker (ARB) (ACTION3)
A clinical research study for primary focal segmental glomerulosclerosis (FSGS), or genetic focal segmental glomerulosclerosis (FSGS), or focal segmental glomerulosclerosis (FSGS) of undetermined cause in pediatric (12-17 years) and adult patients. Eligible participants will be assigned to receive either DMX-200 (repagermanium) or placebo (50/50 chance) over a treatment period, with total participation up to 28 month, with potential for participation in an Open Label Extension study period. The main purpose of this study is to see if DMX-200 reduces proteinuria and slows the loss of kidney function in those with FSGS.
• 12-80 years old;
• Primary FSGS, genetic FSGS or FSGS of undetermined cause
• Receiving an ARB, or willing to take one for the study
• see link to clinicaltrials.gov for complete inclusion criteria
• Secondary FSGS
• Not previously treated with standard of care therapies (including steroids)
• Unable to swallow oral medication
• see clinical to clinicaltrials.gov for complete exclusion criteria
NRG-GU012: Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI) (SAMURAI)
The primary purpose of this study is to find out if adding a highly focused form of radiation therapy (called SABR) to the main kidney tumor, along with immunotherapy, helps people with advanced kidney cancer live longer or do better than using immunotherapy by itself.
• diagnosis of renal cell cancer with positive lymph nodes that can't be removed or metastasis to another area
• not recommended for or refused immediate nephrectomy
• must agree to use a highly effective contraception while on study drug and for 6 months following the last dose of study drug
• see link to clinicaltrials.gov for complete inclusion criteria
• untreated or unstable brain metastases
• prior radiotherapy to the kidney
• systemic therapy for metastatic renal cell carcinoma (RCC) that was initiated > 90 days before starting the study
• women who are pregnant or breastfeeding -see link to clinicaltrials.gov for complete 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
Zymfentra (Infliximab-dyyb) REal World Cohort STudy (ZEST)
The goal of this study is to learn more about the safety and effectiveness of Zymfentra treatment for people with inflammatory bowel disease (IBD), Crohn’s disease, and ulcerative colitis. Researchers will collect information about symptoms, treatment response, and side effects over time to better understand how Zymfentra works for people with IBD.
• diagnosis of Crohn’s disease (CD), ulcerative colitis (UC), or inflammatory bowel disease unclassified (IBDU)
• starting or switching to Zymfentra treatment for inflammatory bowel disease
An open, parallel-group, randomized, early feasibility trial to evaluate the initial safety and performance of the INGA catheter in labor induction
The purpose of this study is to evaluate the safety and effectiveness of a new device used during labor induction. We will enroll pregnant adults who are at least 37 weeks pregnant and are scheduled to have labor induced using a balloon catheter. The study will evaluate whether the device can improve monitoring of the pregnant person and baby during labor.
• pregnant adults ages 18–56
• at least 37 weeks pregnant
• pregnant with one baby
• planning to have labor induced using a balloon catheter
• pregnant with more than one baby (twins, triplets, etc.)
• baby is not in a head-down position
• previous cesarean section or other surgery that left a scar on the uterus
• you or your baby need immediate delivery for medical reasons
A PHASE 2 STUDY OF ALISERTIB IN COMBINATION WITH ENDOCRINE THERAPY IN PATIENTS WITH HR+, HER2-NEGATIVE RECURRENT OR METASTATIC BREAST CANCER (ALISCA-Breast1)
The purpose of this study is to see if the study drug, called alisertib, in combination with an ‘endocrine therapy’ such as anastrozole, letrozole, exemestane, tamoxifen or fulvestrant can help people with HR+, HER2-negative recurrent or metastatic breast cancer. The study will also look at how well people tolerate treatment with alisertib in combination with one of the endocrine therapies that are commonly used in clinical practice.
• diagnosis of adenocarcinoma of the breast that has reoccurred of spread to other areas of the body (metastatic)
• treatment with at least two prior lines of endocrine therapy in the recurrent or metastatic setting
• see link to clinicaltrials.gov for complete inclusion criteria
• treatment with chemotherapy in the recurrent or metastatic setting
• see link to clinicaltrials.gov for complete exclusion criteria
Cell free and circulating tumor DNA in the management of muscle invasive bladder cancer, a prospective cohort study.
The goal of this study is to identify the role of cell-free fragments of DNA (cfDNA) and circulating tumor DNA (ctDNA) found in blood and/or urine of patients with bladder cancer in determining whether some patients can avoid chemotherapy and or radical cystectomy. Large numbers of samples need to be analyzed. Participants will be asked to provide additional blood and urine samples; no treatment is provided in this study.
• people who may have invasive bladder cancer
• planning to have a transurethral resection of bladder tumor (TURBT)
• women who are pregnant
• any other active cancer
• at least able to do self care, up and walking & carry out light work or sedentary activity
Molecular MRI Biomarkers in Parkinson's Disease
This study uses an advanced MRI scan to better understand how the brain produces and uses energy in people with Parkinson's disease (PD). What we learn may improve our understanding of PD and help guide future treatments.
• 40-80 years of age
• diagnosed with Parkinson's disease (PD)
• willingness to undergo brain MRI
• diagnosed with dementia
• have a severe tremor
• have a neurological disorder or condition other than Parkinson's disease
• pregnant or planning to become pregnant during the study
• foreign objects or metal in the body that would prevent MRI participation
A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL, STUDY EVALUATING THE EFFICACY AND SAFETY OF NANVURANLAT IN PATIENTS WITH PREVIOUSLY TREATED ADVANCED BILIARY TRACT CANCER (Beacon-BTC)
This study is for people with advanced biliary tract cancer (cancer of the bile ducts or gallbladder) that cannot be removed with surgery or has spread to other parts of the body. Participants must have previously received one standard chemotherapy treatment for advanced disease. Researchers are studying an investigational medication called nanvuranlat to see if it is safe and effective for treating advanced biliary tract cancer. The study will compare nanvuranlat with standard treatment to learn how well it works, monitor its safety, and better understand how it affects the body and the cancer.
• diagnosed with advanced or metastatic biliary tract cancer (including intrahepatic, extrahepatic, or gallbladder cancer) that cannot be removed with surgery
• previously received one platinum-based chemotherapy treatment for advanced disease
• able to carry out light daily activities
• see link to clinicaltrials.gov for complete Inclusion criteria
• received certain cancer treatments, radiation therapy, or major surgery too recently before starting the study
• active or untreated brain metastases or uncontrolled serious medical conditions
• pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
A Window of Opportunity Trial of Mirdametinib plus Vorinostat for NF1 Associated, Malignant Peripheral Nerve Sheath Tumor; MPNST (Le-Na)
This is a small, Phase 0, window of opportunity study to provide human experience to support our pre-clinical data and gain preliminary information regarding the safety and tolerability of mirdametinib and vorinostat when given in combination.
• Known Neurofibromatosis type 1 (NF-1) syndrome based on current diagnostic criteria
• Diagnosis of suspected MPNST by PET or MRI imaging
• Confirmation of histone H3 lysine 27 trimethylation-negative MPSNT by immunohistochemistry
• Twelve years of age or older - Complete blood count (CBC), platelet, liver and kidney function within institutional normal limits performed within 14 days of 1st dose of study drug
• Must be able to swallow capsules
• Females of childbearing potential must use highly effective contraception (see inclusion criteria section) from the time of study enrollment through 6 months after the last dose of vorinostat and mirdametinib
• Males with partners of childbearing potential must use highly effective contraception from the time of study enrollment through 3 months after the last dose of vorinostat
• Provides voluntary written consent prior to any study related activities, with parental/guardian consent and assent for those 12 to 17 years of age at enrollment
• Pregnant or breastfeeding – females of childbearing potential must have a negative pregnancy test (serum and urine) within 7 days prior to the 1st dose of the study drugs
• Significant cardiac disease
• Ophthalmologic conditions
• Radiation therapy or chemotherapy in the past year
• Participants receiving systemic or ocular glucocorticoid therapy within 14 days prior to the first dose of study treatment
Circuit-Based Deep Brain Stimulation for Parkinson's disease; Udall Clinical Core
The goal of this study is to provide comprehensive longitudinal assessments of a cohort of PD patients before, during, and after DBS surgery, including neurological, neurophysiological, and neuropsychological data.
• age 21 years and older
• diagnosis of Parkinson's disease
• approved candidate for standard of care DBS surgery at the University of Minnesota
• diagnosis of dementia
• women who are pregnant
An interventional Phase 3, open-label, two-cohort study to investigate the efficacy and safety of fosmanogepix in adult patients with invasive mold infections caused by Aspergillus spp., Fusarium spp., Lomentospora prolificans, Mucorales fungi, or other multidrug resistant molds
The purpose of this study is to compare the effects of the study drug fosmanogepix with that of other currently approved treatments to find out if fosmanogepix is safe and effective in treating participants with invasive mold infections. Participants will be assigned to one of two groups depending on the study treatment already received for the current mold infection. Participation in this study will be for a maximum of 8 months.
• diagnosis of proven or probable Invasive mold infection
• see link to clinicaltrials.gov for complete Inclusion criteria
• need or anticipated need for hemodialysis, peritoneal dialysis, or hemofiltration
• moderate or severe liver disease
• known human immunodeficiency virus infection
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
HEALEY ALS Platform Trial
The HEALEY ALS Platform Trial is a research trial that tests the safety and effectiveness of multiple treatments in ALS. A regimen is a specific course of treatment, each with a different study drug. We are doing this research to find out if different treatments have an effect on Amyotrophic Lateral Sclerosis (ALS). We also want to find out if these treatments are safe to take without causing too many side effects.
• 18 years or older
• diagnosed with sporadic or familial ALS
• weakness started no more than 36 months ago -able to to swallow pills and liquids
• unstable medical or mental health condition
• limitations on prior or current use of certain medications (study staff will review)
• women who are pregnant or breast feeding
The University of Minnesota Perinatal Health Repository
This research is being done to collect blood and placenta samples to better understand how pregnancy impacts the health of mother and child. The goal of this research is to better understand what causes some pregnancy complications and how this impacts the longer term health of mothers and children.
• pregnant women who are at least 18 years of age and their neonates/children
• seen in Obstetrics and Gynecology Clinics for pre-conception, prenatal or postpartum care
MT2025-36: Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination with Pembrolizumab Versus Investigator s Choice in HLA-A*02:01-positive Participants with Previously Treated Advanced Melanoma (TEBE-AM)
This study is about treatment of Melanoma (a kind of skin cancer) that has spread or cannot be surgically removed and has gotten worse after standard treatments. This study includes patients with melanoma from any part of the body except the eye. The main purpose of this study is to learn if the study medicine (tebentafusp), alone or a combination with pembrolizumab, helps patients with advanced melanoma live longer. The combination of pembrolizumab and tebentafusp used in this study is experimental.
• unresectable Stage III or Stage IV non-ocular melanoma
• may not be able 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 criteria
• women who are pregnant or breastfeeding
• diagnosis of ocular or metastatic uveal melanoma
• history of a another type of cancer
• unable to be retreated with pembrolizumab because of a previous severe side effect
• significant pulmonary or cardiac disease or impaired lung or cardiac function
• known psychiatric or substance abuse disorders
• see link to clinicaltrials.gov for complete Exclusion criteria
Studying causal inference, affordances, and planning by playing Tetris
Researchers are studying how the brain processes visual information and plans actions. Participants will play the popular arcade game Tetris and watch replays of their gameplay while researchers measure brain activity using a safe, non-invasive EEG. The results may help researchers better understand how the brain solves problems and plans future actions.
• age 18-36 years old
• right-handed
• normal (or corrected) vision
• normal hearing
• history of epilepsy
A double blind, randomized, placebo-controlled exploratory trial to investigate the efficacy and safety of nerandomilast over 24 months when administered in individuals with interstitial lung abnormalities and a family history of pulmonary fibrosis to reduce the risk of worsening (DROP-FPF)
The purpose of this study is to find out if a study drug called nerandomilast can help slow down or reduce worsening lung scarring in people with a family history of pulmonary fibrosis. This study compares nerandomilast with a placebo to see if there is a difference in lung changes seen on scans and lung function over time. The placebo looks like nerandomilast but does not contain any active drug.
• at least 40 years old
• have at least 1 close biological family member (parent, sibling, or child) diagnosed with pulmonary fibrosis or a related lung scarring condition
• imaging scan showing early signs of lung scarring or interstitial lung disease (ILD)
• see link to clinicaltrials.gov for complete Inclusion criteria
• known or more advanced pulmonary fibrosis that may require treatment with approved therapies
• medical conditions known to increase the risk of pulmonary fibrosis, such as some connective tissue diseases
• prior or current use of certain pulmonary fibrosis medications including nerandomilast, nintedanib, or pirfenidone
• see link to clinicaltrials.gov for complete Exclusion criteria
Use of CA125 and Complementary biomarkers for the early detection of Ovarian Cancer in Low Risk Women (ID01-022)
This study aims to evaluate the ROCA2 algorithm, which calculates a woman's risk of having ovarian cancer based on age and biomarkers, for the early detection of ovarian cancer in a low risk cohort of women.
• women age 50 to less than 75 years old
• postmenopausal, which means no period for one year or longer
• have at least one ovary
• cancer-free and have not received any chemotherapy or radiation therapy for at least 12 months, exceptions may be available
• have a health care provider who does yearly well-woman exam
• willing to have a biomarker blood test yearly
• willing to have a transvaginal ultrasound if indicated by screening test
• prior removal of both ovaries
• have an active non-ovarian cancer
• high risk for ovarian cancer due to known familial predisposition (known mutation in BRCA1 or BRCA2, family history of ovarian or breast cancer). Study staff will review
EX-VIVO TARGETED TREATMENT OF CANCEROUS EXTIRPATED PROSTATE TISSUE
This study focuses on testing new treatments on prostate tissue that has been removed during surgery. All testing is done in a lab setting to help develop and improve potential treatment options.
• age 18 or older
• scheduled to undergo a radical prostatectomy
• able to understand and provide informed consent
AREN2231; Risk Adapted Treatment of Unilateral Favorable Histology Wilms Tumors (FHWT)
This study aims to improve the outcomes within cohorts of favorable-histology Wilms tumor (FHWT) patients, and maintain those outcomes despite therapy reduction. In this case, an improved outcome would be considered an improvement in event-free survival rates (EFS). Patients will be stratified to different treatment groups based upon age, response to treatment, and other factors. This trial will include six chemotherapy treatment regimens, and there will also be expansion and refinement of the cohort of patients who are treated with nephrectomy only. Exploratory aims will address aspects such as radiology, surgery, radiation oncology, pathology, and the biological aspects of FHWT.
• Age: Patients must be more than 30 years old
• Diagnosis: Patients with newly diagnosed Stage I-IV - Favorable Histology Wilms Tumor confirmed by central review and with a qualifying Initial Stratum Assignment received on APEC14B1-REN
• Patient with a diagnosis of Stage V Bilateral Wilms Tumor
• Patients who in the opinion of the investigator are not able to comply with the study procedures are not eligible -Patients with any uncontrolled, intercurrent illness including but not limited to symptomatic congestive heart failure
• Patients with Stage I FHWT with a known or suspected Wilms Tumor predisposition syndrome or condition (contralateral nephrogenic rests and/or unilateral multicentric tumors) are excluded from treatment on the mVLR (Nephrectomy Only) arm
A Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression (HARMONi-7)
The purpose of this research is to measure the safety and effectiveness of ivonescimab compared to pembrolizumab. Ivonescimab is an antibody designed to block proteins that help cancer cells grow and spread, and by blocking these proteins may potentially slow cancer progression. Participants will have a 50% chance of being assigned to either the ivonescimab treatment group or the pembrolizumab treatment group.
• 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
• diagnosis of metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC)
• have not received any treatment
• see link to clinicaltrials.gov for complete Inclusion criteria
• small cell lung cancer
• known genetic alterations that have treatment options
• have received treatment for this cancer
• see link to clinicaltrials.gov for complete Exclusion criteria
MOMENTOUS study (iMpact Of an ecg ai ModEl oN The diagnosis Of pUlmonary hypertenSion) (MOMENTOUS)
The purpose of this study is to understand if a new tool will help improve early detection of pulmonary hypertension (PH) in patients with interstitial lung disease. Pulmonary hypertension is high blood pressure in the pulmonary artery (which carries blood from your heart to the lungs). We are testing a tool that looks at an electrocardiogram (ECG) to find patients who are identified as being high risk for having PH that is not yet diagnosed. Participation in this study will last approximately six months.
• diagnosis of interstitial lung disease
• diagnosis of pulmonary hypertension
• LV ejection fraction ≤ 40% on most recent echo or cardiac MRI
EFC17574: A Phase 3, single-arm, multicenter, multinational, open label, one-way crossover study to investigate the efficacy and safety of fitusiran prophylaxis in male participants aged >= 12 years with severe hemophilia A or B, with or without inhibitory antibodies to factor VIII or IX (ATLAS-NEO)
A study to test a medicine (fitusiran) injected under the skin for preventing bleeding episodes in male adolescent or adult participants with severe Hemophilia.
• 12 years or older
• diagnosis of severe congenital hemophilia A or B
• participants currently not on prophylaxis (CFC or BPA on-demand): A minimum of 4 bleeding episodes requiring BPA (inhibitor participants) or CFC (non-inhibitor participants) treatment within the last 6 months
• co-existing bleeding disorders other than congenital hemophilia A or B
• current participation in immune tolerance induction therapy (ITI)
• prior treatment with gene therapy
• acute hepatitis, ie, hepatitis A, hepatitis E, acute or chronic hepatitis B infection
• additional exclusion criteria apply (study staff will review)
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY OF VE303 FOR PREVENTION OF RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION: THE RESTORATIVE303 STUDY (RESTORATiVE303)
The purpose of RESTORATiVE303 is to see if the study drug, which is called VE303, is safe and effective in preventing another episode of Clostridioides Difficile Infection (CDI). VE303 is an investigational drug that has 8 strains of live bacteria, called “commensals.” Commensals are the type of bacteria that live in harmony with the body, without harming health. These specific bacteria are often found in the intestines of normal, healthy people. They were selected for inclusion in VE303 because they rarely infect humans (mostly in very weakened patients), they do not carry any toxins that can make one sick, and they are not known to carry any risk of creating or spreading resistance to antibiotics.
• at least 12 years old
• laboratory-confirmed Clostridium Difficile Infection (CDI) and at least one prior occurrence of CDI within the last 6 months
• OR 75 years or older with laboratory confirmed CDI
• OR CDI with additional risk factors
• see link to clinicaltrials.gov for additional inclusion and exclusion criteria
• history of chronic diarrhea unrelated to CDI
• history of celiac disease, inflammatory bowel disease, microscopic colitis, short gut, GI tract fistulas, or a recent episode (within 6 months) of intestinal ischemia or ischemic colitis
MT2023-51 A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Metastatic Non-Small-Cell Lung Cancer
This study is being done to learn more about the efficacy and safety of LN-145 in participants with metastatic stage IV non-small cell lung cancer.
• confirmed diagnosis of metastatic Stage IV NSCLC without specific genomic alterations
• if the tumor has a treatable mutation(s) (other than EGFR, ALK, or ROS1 genomic alterations), 1 additional line of therapy with the appropriate targeted therapy is required
• may be restricted from strenuous activity but walking and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months after all protocol-related therapy
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
• on systemic steroid therapy ≥ 10 mg/day of prednisone or equivalent
• have any form of primary immunodeficiency
• had another primary cancer within the previous 3 years
MT2022-27: TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients
People planning to undergo a bone marrow transplant and are at risk for developing problems with the lungs related to this planned therapy. The types and seriousness of lung problems that may develop after transplant can be very different and currently, we don’t exactly know what risk factors influence who develops them or how they may respond to therapy. Also, we do not know what the best test is to monitor lung function after transplant, especially in children and young adults. The purpose of this study is to help investigators learn more about lung problems after bone marrow transplant including what is the best method for diagnosing lung problems and following how well the lungs are working. In this study, clinical information, laboratory results and imaging findings will be collected from medical records to assist researchers in learning more about lung complications after bone marrow transplant.
• up to 24 years old
• undergoing allogeneic or autologous HSCT