Search Results
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
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
Influence of functional hypothalamic amenorrhea on autonomic blood pressure regulation in female endurance athletes
This study is being done to learn more about how hormone changes related to menstrual cycle disruption and underfueling in highly trained endurance athletes may affect blood pressure regulation, blood vessel function, and cardiovascular health. Researchers will measure heart rate, blood pressure, blood vessel function, and nervous system activity in endurance athletes to better understand how these factors differ between athletes.
• females ages 18–35
• endurance athletes who regularly participate in sports such as running, cycling, swimming, skiing, rowing, or multisport activities
• current injury limiting training participation
• pregnant or breastfeeding
• use of depo provera, nexplanon implants, or progestin-only oral contraceptives
• diabetes or significant heart, lung, neurologic, metabolic, or endocrine conditions
• nicotine/tobacco use in the last six months
• current use of heart or blood pressure medications
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
A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined with JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer
The purpose of this study is to assess whether JNJ-87189401 given in combination with pasritamig (JNJ-78278343) to men with metastatic castration-resistant prostate cancer (also known as mCRPC) can cause side effects, and to find doses for the two drugs when given in combination. Side effects are unexpected or unwanted reactions from receiving the study drugs. Additionally, the study will look at how long JNJ-87189401 and pasritamig stay in the body, how they act on the body, and how the body responds to them.
• confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted
• Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist)
• fully active, able to carry on all pre-disease performance without restriction or 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 clinical trials.gov for complete Inclusion criteria
• active autoimmune disease in the 12 months that requires systemic immunosuppressive medications (example, chronic corticosteroids, methotrexate, or tacrolimus)
• any of the following within past 6 months: myocardial infarction, severe or unstable angina, significant ventricular arrhythmias, congestive heart failure, transient ischemic attack (TIA), or Cerebrovascular accident (CVA, stroke)
• see link to clinicaltrials.gov for complete Exclusion criteria
HM2023-43: A phase 2 trial of tafasitamab in combination with lenalidomide+rituximab in treatment-naive follicular lymphoma and marginal zone lymphoma
This study is to see if patients who get tafasitamab in addition to the standard regimen of lenalidomide and rituximab when they are just starting treatment are more likely to stay in remission after treatment than those who do not. We expect that participants will be in this research study for approximately 3 years total. Patients will be on active treatment for approximately 1 year.
• confirmed marginal zone lymphoma
• have not received systemic therapy for lymphoma
• need treatment because of bulky disease, associated symptoms, or causing problems with vital organs (heart, spleen, lung)
• see link to clinicaltrials.gov for complete Inclusion criteria
• active HIV, Hepatitis B, Hepatitis C
• prior history of lenalidomide use
• history of another cancer in the past 5 years
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator s Choice in Participants with Chemotherapy-naïve Metastatic Castration resistant Prostate Cancer
This research study is being done to learn more about how safe and effective the investigational drug xaluritamig is when given in combination with abiraterone acetate compared to standard care (study doctor’s choice of abiraterone acetate, docetaxel, or cabazitaxel) in people with prostate cancer that has spread to other parts of the body but has not yet been treated with chemotherapy in the metastatic castration-resistant prostate cancer (mCRPC) setting.
• diagnosis of metastatic castration-resistant prostate cancer (mCRPC) treated with enzalutamide, darolutamide or apalutamide oral medications
• cancer is adenocarcinoma type
• prior orchiectomy and/or ongoing androgen-deprivation therapy (ADT)
• no prior chemotherapy in the mCRPC setting (up to 6 cycles of docetaxel in the castration sensitive setting is allowed)
• unable 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 complete Inclusion criteria
• history of central nervous system (CNS) metastases
• disease progression on or intolerance to abiraterone
• see link to clinicaltrials.gov for complete exclusion criteria
A Phase 1b Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination with Androgen Receptor Pathway Inhibitors in Participants with Metastatic Hormone-sensitive Prostate Cancer
The main goal of this study is to see if it's safe for people to take xaluritamig together with either darolutamide or abiraterone.
• diagnosis of metastatic adenocarcinoma of the prostate
• started androgen deprivation therapy (ADT) (luteinising hormone-releasing hormone [LHRH] agonist/antagonist or orchiectomy) with or without androgen receptor pathway inhibitor (ARPI) (pre-enrollment treatment with enzalutamide, abiraterone, apalutamide, or darolutamide are allowed).
• first treatment with ADT should be no longer than 12 weeks before starting the study
• see link to clinicaltrials.gov for complete Inclusion criteria
• history of central nervous system (CNS) metastases
• autoimmune disease requiring systemic treatment in the past 2 years
• prior radiotherapy (to the prostate and/or to all visible metastatic lesions; palliative radiation within 2 weeks prior to first dose of study treatment is allowed
• 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
MT2025-50: An Open-label, Multicenter Phase 1/2 Study to Evaluate the Safety and Efficacy of AB-3028 in Patients with Castration Resistant Prostate Cancer (CRPC)
The main purpose of first part of this study is to see if an experimental cell therapy called AB-3028 is a safe and effective treatment for people with metastatic castration resistant prostate cancer (mCRPC). AB-3028 is a personalized cell therapy made from your own white blood cells. The main goals of the first part are to test the safety of the treatment at different dose levels and find the recommended dose for the second part of the study.
• confirmed adenocarcinoma of the prostate
• progressive metastatic castration-resistant prostate cancer
• prior treatment with at least 1 novel androgen receptor pathway inhibitor (ARPI) therapy
• see link to clinicaltrials.gov for complete Inclusion criteria
• Central nervous system (CNS) metastatic disease, leptomeningeal disease, or spinal cord compression
• unwilling to participate in an extended period of monitoring for side effects
• see link to clinicaltrials.gov for complete Exclusion criteria
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
MT2024-43: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects with Rheumatoid Arthritis (Regulate-RA)
The study evaluates the safety and effects of a novel regulatory CARTreg cell-based autoimmune and inflammatory disease therapy for the treatment of rheumatoid arthritis. The therapy is an autologous (using the patient's own cells) Treg cell therapy that targets proteins in the inflamed, disease-associated tissue, with the aim to dampen inflammation and restore balance to the immune system.
• adult-onset, moderate-to-severe rheumatoid arthritis (RA)
• Body mass index (BMI) <35 kg/m^2
• inadequate response to or unable to tolerate available RA therapies
• willing to use highly effective methods of contraception
• see link to clinicaltrials.gov for complete inclusion criteria
• major surgery within 12 weeks prior to screening or planned within 12 months
• uncontrolled heart, lung, kidney, liver, endocrine, or gastrointestinal disease
• recurrent infections or active infection
• see link to clinicaltrials.gov for complete exclusion criteria
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
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
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
Targeted Oligometastatic Radiation in Pediatric and Young Adult Patients with Soft Tissue and Bone Sarcoma (TARGET-RT) (TARGET-RT)
This study aims to improve treatment and outcomes for children, adolescents, and young adults with metastatic sarcoma and help guide future care for this disease.
• younger than 39 years old or were first diagnosed with a soft tissue or bone sarcoma before age 39
• have a newly diagnosed, recurrent, or progressive (continued to grow) soft tissue or bone sarcoma
• have sarcoma that has spread (metastasized) to another part of the body and can be measured on imaging scans
• see link to clinicaltrials.gov for complete inclusion criteria
• have cancer that has spread to the brain or spinal fluid
• have metastatic disease that cannot be measured on imaging scans
• pregnant or breastfeeding
• see link to clinicaltrials.gov for complete exclusion criteria
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)
MT2025-14: A Phase 1a/1b Study of GTB-5550, a Camelid Nanobody TriSpecific Killer Engager (camB7-H3 TriKE®), in Select Advanced Solid Tumors That Failed Prior Therapy
This study will test GTB-5550, a B7H3-targeted natural killer (NK) cell engager, for the treatment of select solid tumor cancers. The study will determine the optimal dose level and evaluate preliminary safety and efficacy.
• confirmed cancer that can be measured on scans
• fully active, able to care for yourself
• have recovered from side effects of any prior cancer treatments
• have adequate blood counts, kidney, liver, heart, and lung function based on recent lab tests
• see link to clinical trials.gov for complete Inclusion criteria
• recent cancer treatment (within 2 weeks)
• have had a prior organ transplant
• are pregnant or breastfeeding
• another active or recent cancer
• see link to clinicaltrials.gov for complete Exclusion criteria
A Phase 1/2 First-in-Human, Open-Label, Dose Escalation and Expansion Trial of TAK-505 Monotherapy in Participants with Unresectable Locally Advanced or Metastatic Solid Tumors
The purpose of this study is to evaluate how TAK-505 works in people with certain advanced solid tumors, including stomach, colorectal, lung, and head and neck cancers. The study will test TAK-505 at different dose levels to understand how it is tolerated, how it behaves in the body, and to help determine the dose that provides the best balance of effect and side effects for future studies.
• confirmed locally advanced or metastatic solid tumor (including stomach, colorectal, lung, and head and neck cancers) that has progressed after standard treatment or has no standard treatment options remaining
• adequate bone marrow, kidney, and liver function
• see link to clinicaltrials.gov for complete inclusion criteria
• significant uncontrolled medical conditions, including serious heart disease, lung disease, active infection, or recent major surgery active autoimmune disease requiring treatment or known HIV, hepatitis B, or hepatitis C infection
• active or unstable brain metastases or other untreated central nervous system disease
• see link to clinicaltrials.gov for complete exclusion criteria
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
PEPN2413; A Phase 1 study of oral cedazuridine and decitabine combination (ASTX727, IND# 175393, NSC# 820631) and filgrastim as maintenance therapy post-hematopoietic stem cell transplant in children with high-risk acute myeloid leukemia
This study is evaluating a new treatment after stem cell transplant for children with high-risk acute myeloid leukemia (AML). Researchers hope to identify a safe dose, better understand possible side effects, and learn how the treatment works in the body.
• less than 21 years old
• newly diagnosed, relapsed, or treatment-resistant Acute Myeloid Leukemia (AML) that is in remission before a planned donor stem cell (bone marrow) transplant
• planning to receive your first donor stem cell (bone marrow), peripheral blood stem cell, or cord blood transplant
• see the ClinicalTrials.gov listing for complete inclusion criteria
• currently receiving another investigational treatment or certain anti-cancer medications
• previous solid organ transplant
• pregnant or breastfeeding
• see the ClinicalTrials.gov listing for complete exclusion criteria
An Observational Study of VYKATTMXR (Diazoxide Choline Extended-Release Tablets) in Patients with Prader-Willi Syndrome (PWS)
This study is collecting information from people with Prader-Willi syndrome (PWS) who are taking VYKAT XR (diazoxide choline extended-release tablets). Researchers will use information from routine medical care to learn more about the long-term safety, treatment experiences, and health outcomes of people treated with VYKAT XR.
• diagnosed with Prader-Willi syndrome (PWS)
• currently taking or planning to start VYKAT XR (diazoxide choline extended-release tablets)
• see link to ClinicalTrials.gov for complete inclusion criteria
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
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
MT2015-25: Tandem Myeloablative Consolidation Therapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma
The primary purpose of this study is to gain information, especially disease free outcomes, using the tandem approach as compared to the historical information of using a single transplant. The data will be analyzed for transplant “milestones” such as time to blood count recovery and how patients are doing at 3 months and 1 year after the treatment. Participation in this study will not alter treatment or medical care. All information for this study will be collected from medical records.
• less than 30 years old when diagnosis of neuroblastoma is made
• no uncontrolled infection
• recovered from acute toxicities of last cycle of induction chemotherapy
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing Lower Respiratory Tract Complications in Patients with Hematologic Malignancies and Recipients of Hematopoietic Stem Cell Transplantation (HSCT) with Documented Viral Infections with Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV)
The purpose of this research study is to see whether an experimental drug, PUL-042 Inhalation Solution (PUL-042), is effective in reducing the severity of lung infections in patients with hematologic malignancies and recipients of hematopoietic stem cell transplantation with viral infections due to PIV, hMPV, or RSV. Participants will receive PUL-042 or a placebo (an inactive agent that appears identical to PUL-042) through a nebulizer. This is a machine that uses a small motor to turn liquid into a mist, like a humidifier, so you can breathe the drug into your lungs. Participants will receive the experimental drug, PUL-042, or a placebo 3 times over a 6-day period.
• nasopharyngeal swab is positive for PIV, RSV, or hMPV (as a single pathogen or a mixed infection with rhinovirus) AND
• diagnosis of a hematologic malignancies (i.e., leukemia, lymphoma, or multiple myeloma) or recipient of an allogeneic or autologous hematopoietic stem cell transplantation for one of the following diagnoses: leukemia, lymphoma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, multiple myeloma, and myelodysplastic and myeloproliferative disorder
• have undergone active chemotherapy within 6 months or are on an immunosuppressive therapy
• symptomatic with upper or lower respiratory tract symptoms such as rhinorrhea, sore throat or cough
• must not be pregnant, plan to become pregnant, or nurse a child during the study and through 30 days after completion of the study
• see link to clinicaltrials.gov for complete Inclusion criteria
• pulse oximetry of hemoglobin saturation less than 93% on room air
• history of chronic pulmonary disease (e.g., asthma [including atopic asthma, exercise-induced asthma, or asthma triggered by respiratory infection], chronic pulmonary disease, pulmonary fibrosis, COPD), pulmonary hypertension, or heart failure
• positive for other respiratory viruses (limited to influenza, SARS-CoV-2, adenovirus, or coronavirus) within 7 days
• see link to clinicaltrials.gov for complete Exclusion criteria
Identifying hearing loss through neural responses to engaging stories
This research study aims to develop a more efficient hearing test that uses brain activity measured with electroencephalographic (EEG) while listening to narrated stories to identify hearing loss at different sound frequencies.
• adults aged 18-29 years
• normal hearing
• proficient in spoken English
• neurological problems
• auditory neuropathy spectrum disorder (ANSD)
• wear a cochlear implant