[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fred Hutchinson Cancer Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":583},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,77,0,25,[9,45,67,92,114,142,163,188,220,240,261,279,300,328,354,381,403,423,445,463,482,502,520,550,565],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100633248","effect-of-meal-timing-during-adjuvant-treatment-for-cancer-100633248",false,"NCT07524218","Effect of Meal Timing During Adjuvant Treatment for Cancer","Effect of Meal Timing During Adjuvant Treatment for Cancer: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Age ≥18 years (no upper age limit)\n* Any sex or gender\n* Histologically or cytologically confirmed solid tumor treated with curative-intent surgical resection and planned initiation of systemic adjuvant therapy (chemotherapy, targeted therapy, immunotherapy, and\u002For radiation per standard of care)\n* BMI ≥18.5 kg\u002Fm2\n* Willing and able to adhere to the assessments, visit schedules, prohibitions, and restrictions\n\nExclusion Criteria:\n\n* No plan for systemic adjuvant therapy after surgery\n* Strictly adhering to a \\\u003C10-hour eating window on most days\n* Regular overnight shift work (≥1 night shift per week)\n* Dependent on parenteral or enteral nutrition\n* Pregnant or breastfeeding\n* Active second malignancy requiring systemic therapy (exceptions: non-melanoma skin cancers or in situ cervical cancers adequately treated)\n* Severe psychiatric, cognitive, or social conditions that would interfere with adherence to study procedures","ALL","18 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to test meal-timing as a novel and sustainable interventional approach during cancer treatment to improve therapeutic response, patient well-being and long-term metabolic health. In alignment with these priorities, we propose to focus on patients with histologically or cytologically confirmed solid tumors treated with curative-intent surgical resection and planned initiation of systemic adjuvant therapy (chemotherapy, targeted therapy, immunotherapy, and\u002For radiation per standard of care).\n\nA promising strategy for improving the efficacy of anticancer treatments and reducing associated toxicities involves combining treatment with fasting regimens. In pre-clinical and clinical studies, various forms of fasting have been shown to induce tumor regression and improve long-term survival. According to the differential stress sensitization theory, fasting is thought to sensitize tumor cells to the cytotoxic effects of chemotherapy and radiation, while protecting healthy cells by increasing stress resistance. While healthy cells slow their growth and become more stress resistant in response to fasting, cancer cells cannot survive in nutrient-deficient environments; although the underlying mechanisms are not fully understood. However, extended water-only fasting can be challenging for patients and poses undue health risks. Intermittent fasting, and specifically time-restricted eating (TRE), may offer a viable alternative. TRE involves eating within a shorter window (e.g., 8 hours) and fasting for the remainder of the day but involves no other dietary restrictions. Because of its simplicity, TRE may be more sustainable than other fasting regimens. TRE also improves several cardio-metabolic endpoints, including insulin sensitivity, which may also be beneficial during anticancer treatments.",[27],"Cancer",[29,30,31],"Time-restricted eating","Time restricted eating","Meal timing","NOT_YET_RECRUITING","2026-06-25",{"date":35,"type":36},"2026-06-29","ACTUAL",{"date":38,"type":21},"2026-07-06",{"date":40,"type":21},"2029-08-31",{"name":42,"class":43},"Fred Hutchinson Cancer Center","OTHER",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100512465","phase-2-ivig-for-infection-prevention-after-car-t-cell-therapy-100512465","NCT05952804","IVIG for Infection Prevention After CAR-T-Cell Therapy","Immunoglobulin Replacement Therapy and Infectious Complications After CD19-Targeted CAR-T-Cell Therapy","Inclusion Criteria:\n\n* Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent\n* For patients with medical incapacity or impaired consciousness such that they are not able to give fully informed voluntary consent, the subjects' legal representative must sign an institutional review board (IRB) approved informed consent document prior to the initiation of any screening or study-specific procedures\n* Participants must be 18 years of age or older\n* Participants will receive an Food and Drug Administration (FDA)-approved CD19-CAR T-cell product for the treatment of hematologic malignancies. Patients receiving an FDA-approved product are eligible even if the product is being administered as part of a clinical trial or expanded access program (e.g., product is 'out of specification'; concomitant anti-tumor treatment such as acalabrutinib)\n* Serum total IgG \\\u003C 600mg\u002FdL within the prior three months\n\n  * Note, if there are additional results ≥ 600 mg\u002FdL within the prior three months, but the patient is receiving IVIG, they remain eligible\n* SUBSEQUENT INFUSIONS: Received an FDA-approved CD19-CAR T-cell product for the treatment of hematologic malignancies\n\nExclusion Criteria:\n\n* Primary congenital selective IgA deficiency\n* Prior serious adverse event\u002Fs related to intravenous immune globulin (IVIG) administration\n* Known serious allergy to any component of IVIG\n* Has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study or interfere with the patient's ability to participate for the full duration of the study or would put the patient at undue risk as judged by the investigator, such that it is not in the best interest of the patient to participate in this study\n* SUBSEQUENT INFUSIONS: Ongoing symptoms of cytokine release syndrome (CRS) and\u002For immune effector cell-associated neurotoxicity syndrome (ICANS) meeting criteria for grade 3 or higher\n* SUBSEQUENT INFUSIONS: Primary congenital selective IgA deficiency\n* SUBSEQUENT INFUSIONS: Has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study or interfere with the patient's ability to participate for the full duration of the study or would put the patient at undue risk as judged by the Investigator, such that it is not in the best interest of the patient to participate in this study\n* SUBSEQUENT INFUSIONS: Receipt of additional therapy for persistence or relapse of the patient's primary malignancy for which they underwent CARTx\n* SUBSEQUENT INFUSIONS: Receipt of bone marrow transplant (allogeneic or autologous) after CARTx\n* SUBSEQUENT INFUSIONS: Any serious adverse event (SAE), clinically significant adverse event (AE), severe laboratory abnormality, intercurrent illness, or other medical condition that indicates to the Investigator that continued participation is not in the best interest of the participant",{"count":53,"type":21},150,[55],"PHASE2","This phase II trial compares the effects of immunoglobulin replacement therapy with a placebo for preventing infectious complications in patients receiving CD19 chimeric antigen receptor (CAR)-T cell therapy. Hypogammaglobulinemia is a common complication in patients who receive CD19 CAR-T cell therapy. This is a condition in which the level of immunoglobulins (antibodies) in the blood is low and the risk of infection is high. Immunoglobulin replacement therapy works by replacing the body's immunoglobulin G (IgG) antibodies with donor blood product derived IgG antibodies that may help prevent infection. IgG antibodies are often depleted as a result of CAR-T therapy. Giving immunoglobulin replacement therapy may prevent infectious complications in patients receiving CD19 CAR-T cell therapy.",[58],"Hematologic Malignancies","RECRUITING",{"date":35,"type":36},{"date":62,"type":36},"2024-06-10",{"date":64,"type":21},"2028-07-31",{"name":42,"class":43},7,{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":44},"100553947","phase-1-dr-18-to-prevent-or-treat-acute-myeloid-leukemia-or-myelodysplastic-syndrome-relapse-after-hematopoietic-cell-transplantation-the-dr-dream-trial-100553947","NCT06492707","DR-18 to Prevent or Treat Acute Myeloid Leukemia or Myelodysplastic Syndrome Relapse After Hematopoietic Cell Transplantation, the DR. DREAM Trial","Decoy-Resistant Interleukin-18 (DR-18) for Relapse, Pre-emptive Treatment or Prophylaxis After Allogeneic Hematopoietic Cell Transplantation in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome (DR. DREAM)","Inclusion Criteria:\n\n* ≥ 18 years of age (no upper age limit)\n* The most recent HCT was from a 10\u002F10 human leukocyte antigen (HLA)-matched related or unrelated donor (assessed at HLA-A, B, C, DR, DQ)\n* Evidence of blood count recovery at any time post-HCT defined as absolute neutrophil count (ANC) ≥ 0.5 x 10\\^9\u002FL for ≥ 3 consecutive days and platelets ≥ 30 x 10\\^9\u002FL (independent of granulocyte colony-stimulating factor \\[G-CSF\\] or platelet transfusions for 5 days). (Blood count recovery may not be sustained.)\n* Absent, stable or reducing immune suppression in the preceding 4 weeks without GvHD flares\n* Karnofsky performance status (KPS) ≥ 80%\n* Agrees to use a suitable method of contraception during study treatment and for 4 months after the last dose of DR-18\n* Capable of providing informed consent\n* GROUP 1: Documented persistent or recurrent measurable residual AML or MDS after HCT, defined as bone marrow blasts \\\u003C 5% by morphology (unless suspected to be regenerative) and malignant bone marrow blasts \\\u003C 5% by flow cytometry.\n\n  * Note: MRD (\\\u003C 5% malignant blasts) must be detected with flow cytometry testing at University of Washington Medical Center (UWMC)\u002FFred Hutchinson Cancer Center (Fred Hutch) clinical laboratory\n* GROUP 1: Absence of circulating malignant blasts detected by the complete blood count (CBC)\n* GROUP 1: Absence of extramedullary disease\n* GROUP 1: Post-HCT restaging never detected overt relapse or disease persistence, defined as ≥ 5% (non-regenerative) blasts by morphology or flow cytometry, or circulating malignant blasts on CBC, or extramedullary disease\n* GROUP 1: At least 60 days have elapsed since the HCT donor cell infusion (HCT day 0). (There is no upper limit to the time elapsed since HCT.)\n* GROUP 1: No Food and Drug Administration (FDA)-approved targeted therapy for the participant's AML or MDS is available, or if such therapy is available, that class of drugs previously failed for the participant or the participant was intolerant of the therapy\n* GROUP 2: HCT is with post-transplant cyclophosphamide or other form of in vivo or ex-vivo T cell depletion\n* GROUP 2: Informed consent was signed pre-HCT or latest day 28 post-HCT. (Treatment may start as early as 30 days post-HCT.)\n* GROUP 2-ONLY IF AML BY WORLD HEALTH ORGANIZATION (WHO) OR INTERNATIONAL CONSENSUS CLASSIFICATION (ICC) 2022 CRITERIA: Pre-HCT bone marrow shows residual leukemia by flow cytometry (MRD or overt disease with ≥ 5% blasts)\n* GROUP 2-ONLY IF AML BY WHO OR ICC 2022 CRITERIA: The participant had at least 1 course of intensive induction chemotherapy or 2 cycles of hypomethylating therapy with venetoclax or 4 cycles of hypomethylating therapy prior to HCT\n* GROUP 2-ONLY IF MDS BY WHO OR ICC 2022 CRITERIA: Any one of the following high-risk features was detected in the pre-HCT disease course:\n\n  * International Prognostic Scoring System-MDS (IPSS-M) score \"very high\" risk\n  * TP53 pathogenic or likely pathogenic mutation with variant allele frequency (VAF) ≥ 50%\n  * TP53 pathogenic or likely pathogenic mutation with VAF \\\u003C 50% and complex cytogenetics or 5q or 7q cytogenetic abnormalities\n  * Biallelic TP53 mutations\n  * The patient had at least 1 course of intensive induction chemotherapy or 2 cycles of hypomethylating therapy with venetoclax or 4 cycles of hypomethylating therapy and the pre-HCT bone marrow evaluation still shows \\> 5% malignant blasts by flow cytometry\n\nExclusion Criteria:\n\n* Cellular immunotherapy or new targeted therapy in the 4 weeks prior to the first DR-18 injection\n* History of grade 3 or 4 acute GvHD after the most recent HCT\n* History of moderate or severe chronic GvHD after the most recent HCT\n* Active acute or chronic GvHD or other immunologic phenomenon (e.g., immune cytopenias, cryptogenic immunologic pneumonia) in last month requiring systemic therapy (Hydrocortisone or prednisone for adrenal insufficiency at ≤ 10 mg\u002Fday prednisone-equivalent is permitted.)\n* Active moderate-severe thrombotic microangiopathy (TMA) as evidenced by any of the following: \\> 10 schistocytes per high-power field, or required anti-C5 or other anti-complement therapy for TMA in the prior 4 weeks, any of the following manifestations if attributed to TMA in the prior 4 weeks: hypertension, worsening or new renal insufficiency, ≥ 2+ proteinuria, hematochezia, seizure, transient or ongoing neurologic deficits\n* Renal insufficiency: Estimated glomerular filtration rate (eGFR) (calculated per the performing laboratory's standard formula) or measured 24 hour (hr.) creatinine clearance \\\u003C 30 mL\u002Fmin\n* Hemodialysis in the prior 4 weeks\n* Major cardiac event requiring evaluation in the emergency room (ER) or hospitalization in the past 4 weeks\n* New York Heart Association (NYHA) class II or higher congestive heart failure (CHF) in the past 4 weeks\n* Uncontrolled cardiac arrhythmias, including atrial fibrillation\n* Left ventricular ejection fraction (LVEF) \\\u003C 35%. LVEF may be established with echocardiogram or MUGA scan, and left ejection fraction must be ≥ 35%\n* Liver dysfunction: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 5 x upper limit of normal (ULN) or bilirubin \\> 3 x ULN\n* Active uncontrolled infection. Note: Examples of controlled infections:\n\n  * Bacterial infection may be still requiring antibiotics at the time of enrollment, but clinical signs and symptoms of the infection should be improving. If the participant had bloodstream infection, negative blood cultures off antibiotics must be documented prior to initiating DR-18 treatment. For urinary tract infection, a repeat urine culture must be sterile prior to initiating DR-18. Radiographic improvement of bacterial pneumonia may lag behind clinical improvement so is not mandatory prior to DR-18 initiation\n  * Fungal infection may be still requiring antifungal medication at the time of enrollment, but evidence of clinical response to antifungal medication (such as regression of lesions on chest CT) must be available at the time of enrollment\n  * Asymptomatic shedding of respiratory viruses after cessation of antiviral therapy, or if not specifically treated with antiviral therapy, is permitted\n  * Cytomegalovirus (CMV) viremia or organ infection meeting institutional criteria for CMV treatment with antiviral therapy such as ganciclovir, valganciclovir or foscarnet must be on maintenance phase of treatment or must have completed treatment and must not be in the induction treatment phase at the time of enrollment. Low-level CMV viremia not meeting institutional criteria for antiviral therapy is permitted, including low-level viremia in patients receiving CMV prophylaxis with letermovir\n* Any of the following: Pulmonary dysfunction requiring supplemental oxygen, even intermittently, in the past 2 weeks; corrected diffusion capacity of the lung for carbon monoxide (DLCO) or forced expiratory volume in 1 second (FEV1) \\\u003C 60% predicted; bronchiolitis obliterans syndrome; prior diagnosis of idiopathic pulmonary fibrosis; prior diagnosis of drug-induced pneumonitis; cryptogenic organizing pneumonia under active treatment\n* Seizure in the past 4 weeks or significant underlying neurologic disease: Study participants must not have significant active underlying neurologic disease, such as Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, epilepsy, prior symptomatic ischemic or hemorrhagic stroke, or transient ischemic attack, unless approved by principal investigator (PI). Peripheral neuropathy related to diabetes or prior chemotherapy is acceptable\n* Other medical, social, or psychiatric factor that interferes with medical appropriateness and\u002For ability to comply with study, as determined by the PI\n* Known allergic reactions to any of the components of study treatments\n* Concurrent use of other investigational anti-cancer agents\n* Peripheral blood T cell chimerism \\\u003C 40%\n* Pregnant or breastfeeding",{"count":75,"type":21},40,[77],"PHASE1","This phase I trial tests the safety, side effects and best dose of decoy-resistant interleukin-18 (DR-18) and how well it works in treating patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that has come back after a period of improvement (relapsed) or that remains despite treatment (persistent) after hematopoietic cell transplantation (HCT). HCT is the only curative therapy for most forms of AML and MDS. However, relapse occurs in a third of patients and is the most common cause of death after HCT. DR-18, a variant of the human cytokine interleukin-18, binds to IL-18 binding probein (IL-18BP) and overcomes the inhibitory effect of the IL-18BP on IL-18, which may boost the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving DR-18 may be safe, tolerable and\u002For effective in treating patient with relapsed or persistent AML or MDS after HCT.",[80,81,82,83],"Acute Myeloid Leukemia","Myelodysplastic Syndrome","Recurrent Acute Myeloid Leukemia","Recurrent Myelodysplastic Syndrome","2026-06-24",{"date":86,"type":36},"2026-06-26",{"date":88,"type":36},"2024-09-23",{"date":90,"type":21},"2028-10-01",{"name":42,"class":43},{"id":93,"slug":94,"hasResults":12,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":12,"sex":99,"minAge":18,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":44},"100534231","phase-1-cell-therapy-steap1-cart-with-enzalutamide-for-the-treatment-of-patients-with-metastatic-castration-resistant-prostate-cancer-100534231","NCT06236139","Cell Therapy (STEAP1 CART) With Enzalutamide for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer","Phase 1\u002F2 Dose-Escalation and Cohort Study of STEAP1 CART With Enzalutamide in Participants With mCRPC","Inclusion Criteria:\n\n* Tissue confirmation of prostate adenocarcinoma\n* Measurable disease by RECIST 1.1 criteria or bone only metastases with measurable PSA ( ≥ 1 ng\u002FmL)\n* Must have progressed (at least 2 rising PSA levels with at least a 1-week interval and a minimum PSA of 1.0 ng\u002FmL, progression per RECIST 1.1, or 2 or more new bone lesions by bone scan), after becoming castration-resistant\n* Have received the following for metastatic prostate cancer:\n\n  * At least two lines of treatment\n  * At least two Food and Drug Administration (FDA)-approved therapies with at least one being a second generation androgen receptor signaling inhibitor (e.g., abiraterone, darolutamide, apalutamide, or enzalutamide)\n  * All available targeted therapies for which they are eligible in the metastatic setting (e.g., PARP inhibitors for BRCA 1\u002F2 and immune checkpoint inhibitor for MSI-H or TMB-H ≥ 10 mut\u002FMb)\n* Castrate levels of testosterone (\\\u003C 50 ng\u002FdL) with or without the use of androgen deprivation therapy\n* 18 years or older at the time of enrollment\n* Capable of understanding and providing a written informed consent\n* Fertile male participants and their female partners must be willing to use an effective contraceptive method before, during, and for at least 4 months after the STEAP1 CART cell infusion\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Participants will be permitted to receive radiation therapy for palliative purposes throughout the study period, except during the 2-week period prior to undergoing leukapheresis\n* Serum creatinine =\\\u003C 1.5 x upper limit of normal (ULN) or estimated creatinine clearance \\> 50 mL\u002Fmin as calculated using the Cockcroft-Gault formula and not dialysis dependent\n* Total bilirubin ≤ 1.5 x ULN. Participants with suspected Gilbert syndrome may be included if Total bilirubin (Bili) \\> 3 mg\u002FdL but no other evidence of hepatic dysfunction\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 5 x ULN\n* ≤ grade 1 dyspnea and oxygen saturation (SaO2) ≥ 92% on ambient air\n* If pulmonary function tests (PFTs) are performed based on the clinical judgement of the treating physician, participants with forced expiratory volume in 1 second (FEVI) \\>= 50% of predicted and diffusion capacity of the lung for carbon monoxide (DLCO) (corrected) of \\>= 40% of predicted will be eligible\n* Participants \\>= 60 years of age are required to have left ventricular ejection fraction (LVEF) evaluation performed within 1 year prior to lymphodepletion chemotherapy. LVEF may be established with echocardiogram or MUGA scan, and left ejection fraction must be \\>= 35%. Cardiac evaluation for other participants is at the discretion of the treating physician\n* Absolute neutrophil count (ANC) \\> 1500 cells\u002F mm\\^3\n* Hemoglobin \\>= 9 g\u002FdL\n* Platelets \\> 100,000 per mm\\^3\n\nExclusion Criteria:\n\n* Expecting to conceive or father children for the duration of the trial through 4 months after T cell infusion\n* Active autoimmune disease: Participants with active autoimmune disease requiring immunosuppressive therapy are excluded. Case by case exemptions are possible with approval by principal investigator (PI)\n* Corticosteroid therapy at a dose equivalent of \\>15 mg of prednisone per day (or equivalent). Pulsed corticosteroid use for disease control is acceptable\n* Concurrent use of other investigational anti-cancer agents except for androgen deprivation therapy\n* Active uncontrolled infection: human immunodeficiency virus (HIV) positive participants on highly active antiretroviral therapy (HAART) with a CD4 count \\> 500 cells\u002Fmm\\^3 are considered controlled, as are individuals with a history of hepatitis C who have successfully completed antiviral therapy with an undetectable viral load, and those with hepatitis B who have hepatitis well controlled on medication\n* Uncontrolled concurrent illness: Participants may not have uncontrolled or concurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia that would limit compliance with study requirements\n* Untreated brain metastases: Participants with small asymptomatic brain metastases ( \\\u003C 1 cm) or those with brain metastases previously treated and controlled with surgery or radiotherapy will be considered for inclusion at discretion of PI, so long as all other eligibility criteria are met\n* Active treatment for prior immune related adverse event to any immunotherapy: Participants receiving ongoing treatment for prior serious immune-related adverse events are excluded, with exception of hormone supplementation or corticosteroid therapy at equivalent of \\> 15 mg prednisone (or equivalent) per day, unless otherwise approved by PI\n* Significant underlying neurologic disease: Study participants must not have significant active underlying neurologic disease, unless approved by PI. Peripheral neuropathy related to diabetes or prior chemotherapy is acceptable\n* Other medical, social, or psychiatric factor that interferes with medical appropriateness and\u002For ability to comply with study, as determined by the PI\n* Known allergic reactions to any of the components of study treatments","MALE",{"count":101,"type":21},48,[77,55],"This phase I\u002FII trial tests the safety and effectiveness of cell therapy (STEAP1 CART) with enzalutamide in treating patients with prostate cancer that continues to grow despite surgical or medical treatments to block androgen production (castration-resistant) and that has spread from where it first started (the prostate) to other places in the body (metastatic). Prostate cancer is the second leading cause of cancer deaths in men. Localized prostate cancer is often curable and even metastatic disease may respond to treatment for a few years. Despite multiple therapies, including hormone therapy and chemotherapy, metastatic castration-resistant prostate cancer (mCRPC) remains an incurable disease. Recently, adoptive cellular immunotherapies have been developed to transfer immunogenic cells to the patient to produce an anti-tumor response. Chimeric antigen receptor T (CART)-cell therapy is a type of treatment in which a patient's T-cells (a type of immune cell) are changed in the laboratory so they will attack tumor cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's tumor cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Prostate stem cell antigen and prostate specific membrane antigen CAR T cell therapies have been shown to be safe and effective, but objective tumor responses remain rare. STEAP1 is an antigen that promotes cancer growth and spread and is found to be broadly expressed in mCRPC tissues. STEAP1 CART is CAR T cells that have been engineered with a STEAP1 antigen to better target prostate tumor cells. Enzalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of cancer cells. Giving STEAP1 CART with enzalutamide may kill more tumor cells in patients with mCRPC.",[105,106,107],"Metastatic Castration-Resistant Prostate Carcinoma","Metastatic Prostate Adenocarcinoma","Stage IVB Prostate Cancer AJCC v8",{"date":86,"type":36},{"date":110,"type":36},"2024-11-26",{"date":112,"type":21},"2027-03-30",{"name":42,"class":43},{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":121,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":125,"conditions":126,"keywords":131,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":135,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},"100402096","mobile-health-application-pact-to-improve-engagement-in-advance-care-planning-100402096","NCT04515810","Mobile Health Application (PACT) to Improve Engagement in Advance Care Planning","Planning Advance Care Together (PACT) to Improve Engagement in Advance Care Planning","Inclusion Criteria:\n\n* PATIENT: Diagnosis of poor prognosis advanced cancer defined as locally advanced or metastatic solid cancer and\u002For disease progression following at least first line systemic therapy and\u002For relapsed or refractory hematologic cancer.\n* PATIENT: Have internet access through a computer or a mobile device; the principal investigator (PI) will ensure that those who have access to a computer or mobile device have access to a computer or mobile device with internet access to ensure they can complete study procedures.\n* PATIENT: The ability to provide informed consent.\n* PATIENT: Identification of a loved support person if one is available; patients who are unable to identify a support person willing to participate with them will be allowed to continue in the study on their own.\n* PATIENT: 18 years of age or older.\n* SUPPORT PERSON: The person (family member or friend) whom the patient indicates being a support person.\n* SUPPORT PERSON: English speaking.\n* SUPPORT PERSON: 18 years of age or older and able to provide informed consent.\n* PROVIDER: Current clinical practice and\u002For research with advanced cancer patients.\n* PROVIDER: A history of 3+ years working with advanced cancer patients.\n* PROVIDER: 18 years of age or older. Providers across disciplines (e.g., social work, oncology) will be enrolled.\n\nExclusion Criteria:\n\n* PATIENT: Not fluent in English.\n* PATIENT: Severely cognitively impaired (as measured by Short Portable Mental Status Questionnaire scores of \\>= 6) to be delivered by trained study research staff during screening.\n* PATIENT: Too ill or weak to complete the interviews (as judged by the interviewer).\n* PATIENT: Currently receiving hospice at the time of enrollment.\n* PATIENT: Children and young adults under age 18.",true,{"count":123,"type":21},400,[24],"This clinical trial tests a new mobile health application (app) called Planning Advance Care Together (PACT) to help people with cancer talk about and plan for advance care planning (the care they would want if they were unable to communicate) with their loved ones and doctors. The development of the PACT mobile app may help future patients incorporate their social network (typically, but not exclusively, family) into the advance care planning process.",[127,128,129,130],"Locally Advanced Malignant Solid Neoplasm","Metastatic Malignant Solid Neoplasm","Recurrent Hematologic Malignancy","Refractory Hematologic Malignancy",[132,133,134,27],"Advance Care Planning","Advance Directives","End-of-Life",{"date":86,"type":36},{"date":137,"type":36},"2025-02-18",{"date":139,"type":21},"2026-12-31",{"name":42,"class":43},4,{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":44},"100591705","exercise-training-for-the-improvement-of-immune-activity-and-treatment-outcomes-during-immunotherapy-for-non-small-cell-lung-cancer-boost-trial-100591705","NCT06983899","Exercise Training for the Improvement of Immune Activity and Treatment Outcomes During Immunotherapy for Non-small Cell Lung Cancer, BOOST Trial","Boosting the Effects of Immunotherapy Through Exercise Training in Patients With Lung Cancer: The BOOST Trial","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically diagnosed with NSCLC.\n* Currently receiving immunotherapy with a minimum of one month of treatment completed.\n* Having a plan to continue immunotherapy for at least 24 weeks (i.e., study intervention period) at the time of recruitment.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2, indicating the ability to fulfill physical fitness and function assessments.\n* Able to understand and willingness to provide study consent.\n\nExclusion Criteria:\n\n* Participating in ≥ 150 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described exercise intervention, where additional exercise done regularly will contaminate the intervention outcomes.\n* Having medical conditions clinically unstable or uncontrollable, with medications that are deemed high-risk for exercise participation by the study team in consultation with the treating oncologist, using the electric medical record (EMR) and Physical Activity Readiness Questionnaire (PAR-Q). This includes but is not limited to: recent (\\\u003C 6 months) myocardial infarction, uncontrolled arrhythmias, decompensated heart failure, unstable angina, symptomatic severe aortic stenosis, uncontrolled hypertension (≥ 180\u002F110 mmHg), uncontrolled diabetes (hemoglobin A1c \\[HbA1c\\] \\> 10% with symptoms), severe chronic obstructive pulmonary disease requiring hospitalization in past 3 months, and bone metastases with imminent fracture risk. These exclusions are based on the American College of Sports Medicine (ACSM)'s Guidelines for Exercise Testing and Prescription and the American Association of Cardiovascular and Pulmonary Rehabilitation (AACPR)'s Guidelines for Cardiac Rehabilitation Programs for safe exercise in clinical populations.\n* Having a high risk for noncompliance with study procedures, including but not limited to: informed consent, participation in outcome assessments, completion of fasting blood draws, attendance at scheduled sessions, adherence to supervised virtual exercise sessions, and appropriate use of provided monitoring equipment (e.g., heart rate monitor, blood pressure monitor, SpO2 monitor). This determination will be based on a composite assessment of the following factors: history of missed oncology appointments (i.e., three or more uninformed no-shows in the prior six months) and poor responsiveness to study communications (i.e., three or more repeated unreturned calls or emails during the recruitment stage). We will also consider any demonstrated difficulty following instructions during initial scheduling or onboarding, or clinical concern raised by the referring provider. Participants meeting one or more of these criteria likely to impair participation will be considered ineligible.\n* Patients who are non-English speaking that would prevent their participation in the participant survey.",{"count":150,"type":21},100,[24],"This clinical trial studies how well exercise training works in improving immune activity and treatment tolerance and response in patients with non-small cell lung cancer (NSCLC) who are receiving immunotherapy. Immunotherapy may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. The use of immunotherapy for the treatment of NSCLC has been rapidly increasing. Although immunotherapy have shown great potential in cancer therapy, not all patients benefit from this therapy and resistance to it can occur. This could be due to poor immune activity. It has been shown that exercise can enhance systemic immune activity in various ways. The exercise training used in this study is aerobic interval training. Aerobic interval training increases the heart rate and the body's use of oxygen and alternates short periods of intense aerobic exercise with less intense recovery periods. This may cause biological changes which may improve immune activity and treatment response in patients with NSCLC who are receiving immunotherapy.",[154],"Lung Non-Small Cell Carcinoma","2026-06-22",{"date":157,"type":36},"2026-06-23",{"date":159,"type":36},"2026-01-28",{"date":161,"type":21},"2028-05-31",{"name":42,"class":43},{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":17,"minAge":169,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":172,"conditions":173,"keywords":181,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":187,"locationsCount":44},"100577736","effect-of-meal-timing-during-cancer-treatment-in-patients-in-alaska-a-randomized-clinical-trial-100577736","NCT06802172","Effect of Meal Timing During Cancer Treatment in Patients in Alaska: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Male or female\n* Self-identify as Alaska Native or American Indian person and eligible for care at the ANMC\n* Age≥21 years\n* Histologically confirmed rectal cancer stage II, III, or IV (if curative) per AJCC criteria (neoadjuvant)\n* Histologically confirmed HER2+ or triple negative breast cancer stage I, II, or III, per AJCC criteria (neoadjuvant)\n* Histologically or cytologically confirmed solid tumor (adjuvant)\n* BMI≥18.5 kg\u002Fm2\n* Plan to receive neoadjuvant or adjuvant therapy\n* Planned duration of neoadjuvant or systemic adjuvant therapy for \\>3 months to allow sufficient time to assess impact of intervention\n* Must have capacity to give informed consent\n* Willing and able to adhere to the assessments, visit schedules, prohibitions, and restrictions\n* Has completed ≤ 4 weeks of neoadjuvant or adjuvant treatment prior to study enrollment\n* Score of \\\u003C 4 on U.S. Household Food Security Survey Module: Six-Item Short Form OR if score \\>5, have clearance from dietitian\n\nExclusion Criteria:\n\n* History of cytotoxic chemotherapy ≤12 months prior to rectal or breast cancer diagnosis (neoadjuvant)\n* Allergic reaction to any of the treatment agents\n* Any prior pelvic radiotherapy\n* Active second malignancy (exceptions: non-melanoma skin cancers or cervical carcinoma in situ adequately treated) requiring systemic therapy\n* History of GI perforation ≤12 months prior to enrollment\n* History of predisposing colonic or small bowel disorders with severe or rapidly worsening symptoms (not related to current cancer symptoms)\n* Receiving any parenteral nutrition or enteral (tube) feeding or using similar nutritional supplement during the study period\n* History of uncontrolled CHF defined as NYHA Class III or greater\n* Pre-existing grade ≥3 neuropathy\n* Currently participating in or has participated in a study of an investigational agent or investigational device ≤4 weeks of the first dose of treatment\n* Unstable psychiatric, sleep, or circadian conditions (common conditions such as sleep apnea and depression are acceptable as long as they are stabilized and not rapidly worsening)\n* Pregnant or breastfeeding\n* Currently perform overnight shift work \\>1 day\u002Fweek\n* Strictly adhering to a \\\u003C10-hour eating window on most days\n* Severe psychiatric, cognitive, or substance misuse disorders or social conditions that would interfere with adherence to study procedures.","21 Years",{"count":150,"type":21},[24],"The goal of this clinical trial is to test meal-timing as a novel and sustainable interventional approach during cancer treatment to improve therapeutic response and metabolic health in an understudied population. This clinical trial will enroll patients with rectal or breast cancer receiving neoadjuvant treatment at the Alaska Native Medical Center (ANMC), which is part of the Alaska Native Tribal Health Consortium (ANTHC).\n\nA promising strategy for improving the efficacy of anticancer treatments and reducing associated toxicities involves combining treatment with fasting regimens. In pre-clinical and clinical studies, various forms of fasting have been shown to induce tumor regression and improve long-term survival. According to the differential stress sensitization theory, fasting is thought to sensitize tumor cells to the cytotoxic effects of chemotherapy and radiation, while protecting healthy cells by increasing stress resistance. While healthy cells slow their growth and become more stress resistant in response to fasting, cancer cells cannot survive in nutrient-deficient environments; although the underlying mechanisms are not fully understood. However, extended water-only fasting can be challenging for patients and poses undue health risks. Intermittent fasting, and specifically time-restricted eating (TRE), may offer a viable alternative. TRE involves eating within a shorter window (e.g., 8 hours) and fasting for the remainder of the day but involves no other dietary restrictions. Because of its simplicity, TRE may be more sustainable than other fasting regimens. TRE also improves several cardio-metabolic endpoints, including insulin sensitivity, which may also be beneficial during anticancer treatments.",[174,175,176,177,178,179,180],"Rectal Cancer Stage II","Rectal Cancer Stage III","Breast Cancer Stage I","Rectal Cancer Stage IV","Breast Cancer Stage II","Breast Cancer Stage III","Solid Tumor Cancer",[29,30,31],"2026-06-19",{"date":84,"type":36},{"date":185,"type":21},"2026-07-07",{"date":40,"type":21},{"name":42,"class":43},{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":22,"phases":197,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":44},"100643958","phase-1-enfortumab-vedotin-pembrolizumab-and-quemliclustat-for-the-treatment-of-unresectable-locally-advanced-and-metastatic-urothelial-cancer-100643958","NCT07667335","Enfortumab Vedotin, Pembrolizumab and Quemliclustat for the Treatment of Unresectable Locally Advanced and Metastatic Urothelial Cancer","A Phase Ib\u002FII Study to Evaluate the Safety and Efficacy of Enfortumab Vedotin Plus Pembrolizumab in Combination With Quemliclustat in Unresectable Locally Advanced and Metastatic Urothelial Carcinoma","Inclusion Criteria:\n\n* Participants must be at least 18 years of age on the day of signing informed consent. Participant (or legally authorized representative if applicable) provides written informed consent for trial\n* Participants must have previously untreated locally advanced or metastatic bladder cancer including bladder cancer \\[stage IIIB: T1-T4N2-3M0, stage IVa: T4bAnyNM0 or AnyTAnyNM1a, and stage IVB: AnyTAnyNM1b clinical stage per American Joint Commission on Cancer (AJCC)\\] or renal pelvis or ureter cancer \\[stage IV: T4Nx-0M0, AnyTN1-2M0, AnyTAnyNM1 clinical stage per AJCC\\]. Lymph node with ≥ 15 mm short axis or biopsy-positive for carcinoma will be considered pathologically enlarged and measurable\n* Participants must have either conventional urothelial carcinoma or urothelial carcinoma variants. A review of pathology by a local expert genitourinary (GU) pathologist is required to confirm the diagnosis. Any component (%) of non-conventional urothelial noted on tumor specimen is allowed for only histologic subtypes listed below in up to 20% of participants enrolled in this study.\n\n  * Urothelial carcinoma with squamous differentiation\n  * Urothelial carcinoma with glandular differentiation\n  * Urothelial carcinoma with trophoblastic differentiation\n  * Nested urothelial carcinoma\n  * Tubular and microcystic urothelial carcinoma\n  * Micropapillary urothelial carcinoma\n  * Lymphoepithelioma-like urothelial carcinoma\n  * Plasmacytoid urothelial carcinoma\n  * Sarcomatoid urothelial carcinoma\n  * Giant cell urothelial carcinoma\n  * Lipid-rich urothelial carcinoma\n  * Clear cell (glycogen rich) urothelial carcinoma\n  * Poorly differentiated urothelial carcinoma\n  * Squamous cell neoplasms including pure squamous cell carcinomas, verrucous carcinomas and squamous cell papilloma\n* Measurable disease by RECIST v 1.1\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2\n* Available baseline fresh biopsy tissue sample obtained in the protocol RG1712006 though clinically indicated procedures or participants must be willing to undergo a baseline research biopsy when safe and feasible\n* Participant must have an estimated life expectancy of at least 3 months\n* Hemoglobin ≥ 9 gr\u002Fdl\n* Absolute neutrophil count: ≥ 1500\u002F µL\n* White blood cell count: ≥ 3000\u002FµL\n* Absolute lymphocyte count: ≥ 1000\u002FµL\n* Platelet count: ≥ 100.000\u002FµL (without transfusion support)\n* Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT): ≤ 2.5 x upper limit of normal (ULN)\n* Total bilirubin: ≤ 1.5 mg\u002Fdl except for patients with Gilbert's syndrome who must have a total bilirubin ≤ 3 mg\u002Fdl\n* Creatinine clearance: ≥ 30 ml\u002Fmin\u002F1.73m\\^2 by the method of Chronic Kidney Disease Epidemiology Collaboration (CKI-EPI) or ≥ 30 ml\u002Fmin by the method of 24 hour (h) clearance of creatinine calculation\n* International Normalized Ratio (INR): \\\u003C 1.5\n\nExclusion Criteria:\n\n* Participants who are receiving any other investigational agents or concurrent anticancer treatment. Participants must have adequate treatment washout period before treatment, defined as: Major surgery (≥ 4 weeks), palliative radiation therapy (≥ 1 weeks from completion of treatment if they have recovered from the acute toxic effect of radiotherapy), prior adjuvant immunotherapy (≥ 4 weeks)\n* Participants whose tumors have any % neuroendocrine or small cell histology, glandular neoplasms, urachal carcinomas, tumor of mullerian type, mesenchymal tumors or urothelial tract hematopoietic and lymphoid tumors\n* Participants considered to be medically unfit for EV-P regimen as per Investigator discretion\n* Participants with concurrent use of systemic steroids (within 10 days of enrollment), except for physiologic doses of systemic steroid replacement or local (topical, nasal, intraarticular or inhaled) steroid use\n* Participants who have experienced disease progression following neoadjuvant or adjuvant systemic therapy within 12 months prior to enrollment will not be eligible\n* Patients with Fridericia's corrected QT interval (QTcF) interval at screening of \\> 480 milliseconds.\n\n  * Note: For any QTcF \\> 480 milliseconds on initial electrocardiogram (ECG), a follow-up ECG will be performed to confirm QTcF interval prolongation and exclude the patient from this study\n* Participants with active systemic autoimmune disease (e.g., lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma, inflammatory bowel disease). Participants with autoimmune endocrine disorders controlled by medical management (e.g. thyroid disorders, type 1 diabetes, or adrenal insufficiency) will not be excluded\n* Participants who are known to be serologically positive for human immunodeficiency virus (HIV) and a CD4 count \\\u003C 350 cells\u002Fmicroliter\n* Participants with known active hepatitis (i.e. Hepatitis B or C). Prior hepatitis (Hep) C infection is allowed as long as polymerase chain reaction (PCR) test is negative\n* Participants with clinically inactive brain metastases may be included. Participants with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole-brain radiation therapy and study treatment\n* Participants with new or progressive brain metastases (less or equal of 1 cm of larger diameter) are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required for at least 4 weeks (or scheduled assessment after the first cycle of treatment), and a risk-benefit analysis (discussion) by the participant and the investigator favors participation in the clinical trial. Patients with leptomeningeal disease will be excluded\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy of assessment of the investigational regimen are eligible for this trial\n* Woman of childbearing potential with positive serum pregnancy test within 72 hours prior to enrollment. Active lactation is an exclusion criterion",{"count":196,"type":21},27,[77,55],"This phase Ib\u002FII trial tests the safety, side effects, and best dose of quemliclustat in combination with enfortumab vedotin and pembrolizumab, and to see how well the combination works for the treatment of bladder, renal pelvis, or ureter urothelial cancer that cannot be removed by surgery (unresectable), that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of cancer cells. Enfortumab attaches to a protein called nectin-4 on cancer cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Quemliclustat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving quemliclustat in combination with enfortumab vedotin and pembrolizumab and may be safe, tolerable and\u002For effective in treating patients with unresectable locally advanced and metastatic urothelial cancer.",[200,201,202,203,204,205,206,207,208,209,210,211,212],"Locally Advanced Bladder Urothelial Carcinoma","Locally Advanced Renal Pelvis Urothelial Carcinoma","Locally Advanced Ureter Urothelial Carcinoma","Metastatic Bladder Giant Cell Urothelial Carcinoma","Metastatic Renal Pelvis Urothelial Carcinoma","Metastatic Ureter Urothelial Carcinoma","Stage IIIB Bladder Cancer AJCC v8","Stage IV Bladder Cancer AJCC v8","Stage IV Renal Pelvis Cancer AJCC v8","Stage IV Ureter Cancer AJCC v8","Unresectable Bladder Urothelial Carcinoma","Unresectable Renal Pelvis Urothelial Carcinoma","Unresectable Ureter Urothelial Carcinoma","2026-06-18",{"date":33,"type":36},{"date":216,"type":21},"2026-12-01",{"date":218,"type":21},"2029-07-16",{"name":42,"class":43},{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":22,"phases":228,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":44},"100634078","dental-cleaning-to-prevent-chronic-graft-versus-host-disease-100634078","NCT07535008","Dental Cleaning to Prevent Chronic Graft-Versus-Host Disease","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* T-replete allogeneic hematopoietic cell transplantation for any indication. History of prior transplantation is allowed. Any conditioning regimen is allowed\n* One of the following HCT donor types:\n\n  * 9\u002F10 or 10\u002F10 human leukocyte antigen (HLA)-matched unrelated donor\n  * Cord blood\n* Willing to have an in-person 1-year long-term follow-up (LTFU) visit including an oral medicine at Fred Hutch (FH)\n* Ability to understand and sign a written informed consent document (or legal representative)\n\nExclusion Criteria:\n\n* Edentulous state\n* Bone marrow as graft source\n* Use of post-transplantation cyclophosphamide (PTCy) or ruxolitinib as GVHD prophylaxis\n* Use of anti-thymocyte globulin (ATG) in conditioning",{"count":227,"type":21},45,[24],"This clinical trial evaluates the feasibility and effectiveness of a post-transplant dental cleaning for the prevention of chronic graft versus host disease (GVHD) in patients undergoing an allogeneic hematopoietic cell transplant (HCT). HCT is the only curative treatment for some types of blood cancer. Unfortunately, this approach can lead to the development of GVHD, which is a disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Some research has shown that the bacteria that is present in the dental plaque soon after transplant may affect the development of chronic GVHD. Dental cleanings prior to transplant are part of the normal standard of care for patients undergoing HCT. Adding an additional cleaning shortly after HCT may be effective for preventing the development of chronic GVHD.",[231,232,233],"Chronic Graft Versus Host Disease","Acute Graft Versus Host Disease","Hematopoietic and Lymphatic System Neoplasm",{"date":155,"type":36},{"date":236,"type":21},"2026-07-15",{"date":238,"type":21},"2029-04-30",{"name":42,"class":43},{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":121,"sex":17,"minAge":18,"maxAge":247,"enrollmentInfo":248,"targetDuration":4,"studyType":22,"phases":250,"briefSummary":251,"conditions":252,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":260},"100636848","a-novel-mobile-health-intervention-for-improving-tobacco-cessation-among-young-adults-100636848","NCT07571018","A Novel Mobile Health Intervention for Improving Tobacco Cessation Among Young Adults","Development and Pilot Evaluation of a Novel Mobile Health Intervention for Young Adult Tobacco Cessation","Inclusion Criteria:\n\n* USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must self-identify being between 18 and 30 years of age\n* USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must be a United States (US) resident, with a US mailing address\n* USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must self-report use of any (non-therapeutic) nicotine or tobacco product at least once per week in the 30 days prior to screening\n* USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must own a smartphone\n* USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must self-report having internet access for the interviews\n* USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must self-report that they are interested in participating in the study for themselves (versus \\[vs\\] someone else)\n* USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must self-report that they have not participated in one of our prior tobacco cessation studies\n* USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must self-report that they understand and agree to the conditions of compensation\n* USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must self-report that they are not currently incarcerated\n* USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must be willing and able to complete study procedures in English\n* PILOT TRIAL: Participants must self-identify being between 18 and 30 years of age\n* PILOT TRIAL: Participants must currently reside in the US and anticipate continued residence for the duration of the study (3 months)\n* PILOT TRIAL: Participants must self-report use of any (non-therapeutic) nicotine or tobacco product at least once per week in the 30 days prior to screening\n* PILOT TRIAL: Participants must own an Android (running version 12 or higher) or iPhone (running iOS version 17 or higher, iPhone 11 or more recent)\n* PILOT TRIAL: Participants must self-report having at least weekly internet access for the next three months\n* PILOT TRIAL: Participants must be willing and able to download an app to their phone and receive text messages\n* PILOT TRIAL: Participants must self-report current use of a personal email account\n* PILOT TRIAL: Participants must self-report current use of text messaging\n* PILOT TRIAL: Participants must self-report that they are interested in participating in the study for themselves (vs someone else)\n* PILOT TRIAL: Participants must self-report that they have not participated in one of our prior tobacco cessation studies\n* PILOT TRIAL: Participants must self-report that they understand and agree to the conditions of compensation\n* PILOT TRIAL: Participants must self-report that they are not currently incarcerated\n* PILOT TRIAL: Participants must be willing to use the assigned intervention program, complete the study assessments, and complete an online consent form in English\n* POST PILOT TRIAL DIARY STUDY: Participants must self-identify being between 18 and 30 years of age\n* POST PILOT TRIAL DIARY STUDY: Participants must currently reside in the US\n* POST PILOT TRIAL DIARY STUDY: Participants must self-report use of any (non-therapeutic) nicotine or tobacco product at least once per week in the 30 days prior to screening\n* POST PILOT TRIAL DIARY STUDY: Participants must own an Android (running version 12 or higher) or iPhone (running iOS version 17 or higher, iPhone 11 or more recent)\n* POST PILOT TRIAL DIARY STUDY: Participants must self-report having at least internet access for the duration of the diary study\n* POST PILOT TRIAL DIARY STUDY: Participants must be willing and able to download an app to their phone and receive text messages\n* POST PILOT TRIAL DIARY STUDY: Participants must self-report current use of a personal email account\n* POST PILOT TRIAL DIARY STUDY: Participants must self-report current use of text messaging\n* POST PILOT TRIAL DIARY STUDY: Participants must self-report that they are interested in participating in the study for themselves (vs someone else)\n* POST PILOT TRIAL DIARY STUDY: Participants must self-report that they have not participated in one of our prior tobacco cessation studies\n* POST PILOT TRIAL DIARY STUDY: Participants must self-report that they understand and agree to the conditions of compensation\n* POST PILOT TRIAL DIARY STUDY: Participants must self-report that they are not currently incarcerated\n* POST PILOT TRIAL DIARY STUDY: Participants must be willing to use the intervention program, complete the study assessments, and complete an online consent form in English\n\nExclusion Criteria:\n\n* USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Individuals must not be \\\u003C 18 or \\> 30 years of age\n* USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Individuals must not have a Google voice number as their sole phone number\n* USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Individuals who are non-English speaking cannot participate, as this would prevent their participation in the interviews, which will be conducted in English\n* PILOT TRIAL: Participants must not be \\\u003C 18 or \\> 30 years of age\n* PILOT TRIAL: Participants must not be currently using other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (but initiating these treatments during the study is allowed)\n* PILOT TRIAL: Participants must not be a member of the same household as another research participant\n* PILOT TRIAL: Participants must not have a Google voice number as their sole phone number\n* PILOT TRIAL: Participants must not be identified as fraudulent per our fraud prevention protocol\n* PILOT TRIAL: Participants must not be pregnant or plan on becoming pregnant over the next 3 months\n* POST PILOT TRIAL DIARY STUDY: Individuals must not be \\\u003C 18 or \\> 30 years of age\n* POST PILOT TRIAL DIARY STUDY: Participants must not have a Google voice number as their sole phone number\n* POST PILOT TRIAL DIARY STUDY: Individuals who are non-English speaking cannot participate, as this would prevent their participation in the interviews, which will be conducted in English","30 Years",{"count":249,"type":21},140,[24],"Tobacco use is the leading cause of preventable cancer deaths. Among young adults, approximately 1 in 5 use commercial nicotine and tobacco products, putting them at risk of developing nicotine addiction and long-term health effects from exposure to toxicants. Innovative approaches are needed to engage young adults in treatment, as they are less engaged in traditional treatment.\n\nThis clinical trial compares two versions of a mobile health intervention called Living Free from Tobacco (LiFT), designed to support nicotine and tobacco cessation among young adults. Both versions of the app are designed to motivate and support young adults to stop using nicotine and tobacco, regardless of current readiness to quit. Version A of the LiFT app (LiFT A) focuses on increasing psychological flexibility to support cessation, while Version B (LiFT B) provides educational content and resources related to tobacco use and cessation. Both versions of the program are delivered through a smartphone application and include accompanying text messages.",[253],"Tobacco-Related Carcinoma",{"date":157,"type":36},{"date":256,"type":36},"2026-06-07",{"date":258,"type":21},"2028-04-01",{"name":42,"class":43},2,{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":121,"sex":17,"minAge":18,"maxAge":247,"enrollmentInfo":268,"targetDuration":4,"studyType":22,"phases":270,"briefSummary":271,"conditions":272,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":274,"startDateStruct":275,"completionDateStruct":276,"leadSponsor":278,"locationsCount":44},"100585986","a-digital-intervention-act-on-vaping-app-for-vaping-cessation-in-young-adult-e-cigarette-users-100585986","NCT06909500","A Digital Intervention (ACT on Vaping App) for Vaping Cessation in Young Adult E-Cigarette Users","ACT on Vaping: Digital Therapeutic for Young Adult Vaping Cessation","Inclusion Criteria:\n\n* Age 18-30\n* Current weekly user of e-cigarette product(s) for the last 30 days\n* Has a smartphone; either an Android (running version 12 or higher) or iPhone (running iOS version 17 or higher, iPhone 11 or more recent)\n* Experience downloading and using one or more apps on their smartphone\n* Have a mobile data plan and\u002For access to WiFi to support the use of the ACT on Vaping app\n* Has access to text messaging\n* Has an email address\n* United States (US) resident, with a US mailing address\n* Willing to complete all study procedures\n* Comfortable reading and writing in English\n\nExclusion Criteria:\n\n* Currently using other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (note: use of these treatment is allowable during trial participation)\n* Member of the same household as another research participant\n* Currently in prison\n* Google voice number as sole phone number, due to its association with fraudulent study entry attempts\n* Is ineligible per fraud prevention protocol\n* Employees\u002Ffamily of investigator or study center",{"count":269,"type":21},1178,[24],"This clinical trial evaluates a smartphone application (app) called Acceptance and Commitment Therapy (ACT) on Vaping for helping young adults quit using electronic cigarettes (e-cigarettes). E-cigarettes pose numerous risks, particularly to youth and young adults. Addressing the high prevalence of e-cigarette use by young adults requires effective and accessible treatments to support current users to quit. Research shows this group prefers and benefits from newer methods of treatment delivery such as digital interventions. ACT on Vaping is a digital therapeutic intended to deliver behavioral therapy to young adults who vape to motivate and support abstinence from all nicotine and tobacco products. The app contains sessions that promote awareness of cues that trigger tobacco use and teach skills for responding to these triggers in a way that is tailored for the participant's readiness to quit. Receiving access to the ACT on Vaping app may be effective in helping young adults quit vaping.",[273,253],"Nicotine Dependence",{"date":155,"type":36},{"date":236,"type":21},{"date":277,"type":21},"2027-11-15",{"name":42,"class":43},{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":121,"sex":17,"minAge":286,"maxAge":287,"enrollmentInfo":288,"targetDuration":4,"studyType":22,"phases":290,"briefSummary":291,"conditions":292,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":294,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":44},"100579302","a-multilevel-intervention-to-increase-colorectal-cancer-screening-tests-in-patients-with-abnormal-fecal-immunochemical-test-results-proact-trial-100579302","NCT06822530","A Multilevel Intervention to Increase Colorectal Cancer Screening Tests in Patients With Abnormal Fecal Immunochemical Test Results, PROACT Trial","PROACT: Promoting Follow-Up of Abnormal Colorectal Cancer Screening Tests Through Multilevel Interventions","Inclusion Criteria:\n\n* PATIENTS: Age \\>= 45 years old and =\\\u003C 75 years old\n* PATIENTS: Receives care at an Harborview Medical Center (HMC) or University of Washington-Kent-Des Moines (UW-KDM) or University of Washington- Federal Way (UW-Federal Way) primary care clinic\n* PATIENTS: \\>= 1 month from documented abnormal FIT result\n* PATIENTS: Has not received a colonoscopy between the abnormal FIT and enrollment\n* CLINIC STAFF: HMC, UW-Federal Way, or UW-KDM physician or staff member who provides primary care or gastroenterology care\n* CLINIC STAFF: Staff in the Fred Hutchinson (Fred Hutch)\u002FUW Medicine Population Health Program that provide colorectal cancer screening and navigation","45 Years","75 Years",{"count":289,"type":21},682,[24],"This clinical trial studies whether an intervention that addresses two or more levels of care (multilevel intervention) increases follow-up of abnormal, non-invasive, colorectal cancer (CRC) screening test results. The fecal immunochemical test (FIT) is a non-invasive, stool-based, CRC screening test. FITs are relatively inexpensive and can be completed at home, for these reasons, it is a preferred method of CRC screening in healthcare settings that care for under-resourced patients or have limited colonoscopy access. For FIT-based CRC screening to be effective, abnormal results must be followed by a colonoscopy, however many patients fail to complete this recommended follow-up test. The multilevel intervention addresses barriers to follow-up colonoscopy at the patient and health system levels of care through a CRC screening patient navigator, an educational video, and transportation assistance. The navigator provides patient support and assistance with colonoscopy scheduling. The educational video addresses identified patient fears around colonoscopies. Transportation assistance is offered after the colonoscopy through a rideshare program to address transportation barriers. Therefore, this multilevel intervention may increase follow-up colonoscopy completion in patients with abnormal FIT results.",[293],"Colorectal Carcinoma",{"date":155,"type":36},{"date":296,"type":36},"2025-12-16",{"date":298,"type":21},"2030-01-31",{"name":42,"class":43},{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":287,"enrollmentInfo":307,"targetDuration":4,"studyType":22,"phases":309,"briefSummary":310,"conditions":311,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":322,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":44},"100295600","phase-1-211at-bc8-b10-before-donor-stem-cell-transplant-in-treating-patients-with-high-risk-acute-myeloid-leukemia-acute-lymphoblastic-leukemia-myelodysplastic-syndrome-or-mixed-phenotype-acute-leukemia-100295600","NCT03128034","211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia","A Study Evaluating Escalating Doses of 211^At-Labeled Anti-CD45 MAb BC8-B10 (211^At-BC8-B10) Followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), or Myelodysplastic Syndrome (MDS)","Inclusion Criteria:\n\n* Patients must have AML, ALL, high-risk MDS, or MPAL (also known as biphenotypic) meeting one of the following descriptions:\n\n  * AML, ALL, or MPAL in first remission with evidence of measurable residual disease (MRD) by flow cytometry\n  * AML, ALL, or MPAL beyond first remission (i.e., having relapsed at least one time after achieving remission in response to a treatment regimen)\n  * AML, ALL, or MPAL representing primary refractory disease (i.e., having failed to achieve remission at any time following one or more prior treatment regimens)\n  * AML evolved from myelodysplastic or myeloproliferative syndromes\n  * MDS expressed as refractory anemia with excess blasts (RAEB)\n  * Chronic myelomonocytic leukemia (CMML) by French-American-British (FAB) criteria\n* Patients not in remission must have CD45-expressing leukemic blasts. Patients in remission do not require phenotyping and may have leukemia previously documented to be CD45 negative (because in remission patients, virtually all antibody binding is to non-malignant cells which make up \\>= 95% of nucleated cells in the marrow)\n* Patients must be \\>= 18 and =\\\u003C 75 years of age\n* Patients should have a circulating blast count of less than 10,000\u002Fmm\\^3 (control with hydroxyurea or similar agent is allowed)\n* Patients must have an estimated creatinine clearance greater than 50\u002Fml per minute by the following formula (Cockcroft-Gault); serum creatinine value must be within 28 days prior to registration\n* Patients must have normal hepatic function (bilirubin within normal limits, aspartate aminotransferase \\[AST\\] and alanine aminotransferase \\[ALT\\] \\\u003C 2 times the upper limit of normal) within 2 months prior to the astatine-211 infusion date (with the exception of patients that are known to have Gilbert's disease, for whom total bilirubin is allowed up to 3 x upper limit of normal \\[ULN\\])\n* Eastern Cooperative Oncology Group (ECOG) \\\u003C 2 or Karnofsky \\>= 70\n* Patients must be free of uncontrolled infection\n* Patients with prior non-myeloablative or reduced-intensity conditioning allogeneic-hematopoietic cell transplant (HCT) must have no evidence of ongoing GVHD and be off GVHD treatment immunosuppression for at least 6 weeks at time of enrollment\n* Patients must have normal elastography\n* If ferritin is elevated, patient must have less than 7 mg\u002Fg liver iron concentration on liver T2\\* MRI\n* Patients should have an official gastrointestinal (GI) consult prior to the transplant for full evaluation\n* Patients must have an HLA-matched related donor or an HLA-matched unrelated donor who meets standard Fred Hutch and\u002For National Marrow Donor Program (NMDP) or other donor center criteria for peripheral blood stem cell (PBSC) or bone marrow donation, as follows:\n\n  * Related donor: related to the patient and genotypically or phenotypically identical for HLA-A, B, C, DRB1 and DQB1; phenotypic identity must be confirmed by high-resolution typing\n  * Unrelated donor:\n\n    * Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; OR\n    * Mismatched for a single allele without antigen mismatching at HLA-A, B, or C as defined by high resolution typing but otherwise matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing\n    * Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment; the recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain panel reactive antibody (PRA) screens to class I and class II antigens for all patients before HCT; if the PRA shows \\> 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained; the donor should be excluded if any of the cytotoxic cross match assays are positive; for those patients with an HLA Class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results; a positive anti-donor cytotoxic crossmatch is an absolute donor exclusion\n  * Patient and donor pairs homozygous at a mismatched allele in the graft rejection vector are considered a two-allele mismatch, i.e., the patient is A\\*0101 and the donor is A\\*0102, and this type of mismatch is not allowed\n\nExclusion Criteria:\n\n* Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects\n* Left ventricular ejection fraction \\\u003C 35%\n* Corrected diffusing capacity of the lungs for carbon monoxide (DLCO) \\\u003C 35% or receiving supplemental continuous oxygen; when pulmonary function test (PFT)s cannot be obtained, the 6-minute walk test (6MWT, also known as exercise oximetry) will be used: Any patient with oxygen saturation on room air of \\\u003C 89% during a 6MWT will be excluded\n* Liver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease\n* Patients who are known to be seropositive for human immunodeficiency virus (HIV)\n* Perceived inability to tolerate diagnostic or therapeutic procedures\n* Active central nervous system (CNS) leukemia at time of treatment\n* Patients with prior myeloablative allogeneic-HCT\n* Women of childbearing potential who are pregnant (beta-human chorionic gonadotropin positive \\[beta-HCG+\\] or breast feeding\n* Fertile men and women unwilling to use contraceptives during and for 12 months post-transplant\n* Inability to understand or give an informed consent\n* Allergy to murine-based monoclonal antibodies\n* Known contraindications to radiotherapy",{"count":308,"type":21},75,[77,55],"This phase I\u002FII trial studies the side effects and best dose of 211\\^astatine(At)-BC8-B10 before donor stem cell transplant in treating patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or mixed-phenotype acute leukemia. Radioactive substances, such as astatine-211, linked to monoclonal antibodies, such as BC8, can bind to cancer cells and give off radiation which may help kill cancer cells and have less of an effect on healthy cells before donor stem cell transplant.",[312,313,80,314,315,82,316,317,318,319,320,321],"Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome","Chronic Myelomonocytic Leukemia","Myelodysplastic Syndrome With Excess Blasts","Refractory Acute Lymphoblastic Leukemia","Recurrent Acute Lymphoblastic Leukemia","Recurrent Mixed Phenotype Acute Leukemia","Refractory Acute Myeloid Leukemia","Refractory Mixed Phenotype Acute Leukemia","Mixed Phenotype Acute Leukemia",{"date":155,"type":36},{"date":324,"type":36},"2017-10-24",{"date":326,"type":21},"2029-03-31",{"name":42,"class":43},{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":287,"enrollmentInfo":335,"targetDuration":4,"studyType":22,"phases":337,"briefSummary":338,"conditions":339,"keywords":343,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":44},"100337247","phase-1-211at-bc8-b10-followed-by-donor-stem-cell-transplant-in-treating-patients-with-relapsed-or-refractory-high-risk-acute-leukemia-or-myelodysplastic-syndrome-100337247","NCT03670966","211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome","A Phase I\u002FII Study Evaluating Escalating Doses of 211At-Labeled Anti-CD45 MAb BC8-B10 (211At-BC8-B10) Followed by Related Haplo-Identical Allogeneic Hematopoietic Cell Transplantation for High-Risk Acute Leukemia or Myelodysplastic Syndrome (MDS)","Inclusion Criteria:\n\n* Patients must have AML, ALL, high-risk MDS, or MPAL (also known as biphenotypic) meeting one of the following descriptions:\n\n  * AML, ALL, or MPAL in first remission with evidence of measurable residual disease (MRD) by flow cytometry;\n  * AML, ALL, or MPAL beyond first remission (i.e., having relapsed at least one time after achieving remission in response to a treatment regimen);\n  * AML, ALL, or MPAL representing primary refractory disease (i.e., having failed to achieve remission at any time following one or more prior treatment regimens);\n  * AML evolved from myelodysplastic or myeloproliferative syndromes;\n  * MDS expressed as refractory anemia with excess blasts (RAEB)\n  * Chronic myelomonocytic leukemia (CMML) by French-American-British (FAB) criteria.\n* Patients not in remission must have CD45-expressing leukemic blasts. Patients in remission do not require phenotyping and may have leukemia previously documented to be CD45 negative (because in remission patients, virtually all antibody binding is to non-malignant cells which make up \\>= 95% of nucleated cells in the marrow).\n* Patients must be \\>= 18 and =\\\u003C 75 years of age.\n* Patients should have a circulating blast count of less than 10,000\u002Fmm\\^3 (control with hydroxyurea or similar agent is allowed).\n* Patients must have an estimated creatinine clearance greater than 50\u002Fml per minute by the following formula (Cockcroft-Gault). Serum creatinine value must be within 28 days prior to registration.\n* Total bilirubin within normal limits\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 2 times the upper limit of normal.\n* Eastern Cooperative Oncology Group (ECOG) \\\u003C 2 or Karnofsky \\>= 70.\n* Patients must be free of uncontrolled infection.\n* Patients with prior non-myeloablative or reduced-intensity conditioning allogeneic-HCT must have no evidence of ongoing GVHD and be off all immunosuppression for at least 6 weeks at time of enrollment.\n* Patients must have normal elastography.\n* If ferritin is elevated, patient must have less than 7 mg\u002Fg liver iron concentration on liver T2 magnetic resonance imaging (MRI).\n* Patients should have an official gastrointestinal (GI) consult prior to the transplant for full evaluation.\n* Patients must have a related donor who is identical for one HLA haplotype and mismatched at the HLA-A, -B or DRB1 loci of the unshared haplotype with the exception of single HLA-A, -B or DRB1 mismatches.\n* DONOR: Donors must meet HLA matching criteria as well as standard Seattle Cancer Care Alliance (SCCA) criteria for PBSC or bone marrow donation. Preference should be given to donors who are mismatched at the HLA-A, -B and -DRB1 loci.\n\nExclusion Criteria:\n\n* Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects.\n* Left ventricular ejection fraction \\\u003C 45%.\n* Corrected diffusion capacity of the lung for carbon monoxide (DLCO) \\\u003C 35% or receiving supplemental continuous oxygen. When pulmonary function tests (PFTs) cannot be obtained, the 6-minute walk test (6MWT, also known as exercise oximetry) will be used: Any patient with oxygen saturation on room air of \\\u003C 89% during a 6MWT will be excluded\n* Liver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease.\n* Patients who are known to be seropositive for human immunodeficiency virus (HIV).\n* Perceived inability to tolerate diagnostic or therapeutic procedures.\n* Active central nervous system (CNS) leukemia at time of treatment.\n* Patients with prior myeloablative allogeneic-HCT.\n* Women of childbearing potential who are pregnant (beta human chorionic gonadotropin \\[B-HCG\\]+) or breast feeding.\n* Fertile men and women unwilling to use contraceptives during and for 12 months post-transplant.\n* Inability to understand or give an informed consent.\n* Allergy to murine-based monoclonal antibodies.\n* Known contraindications to radiotherapy.",{"count":336,"type":21},30,[77,55],"This phase I\u002FII trial studies the side effects and best dose of a radioactive agent linked to an antibody (211At-BC8-B10) followed by donor stem cell transplant in treating patients with high-risk acute leukemia or myelodysplastic syndrome that has come back (recurrent) or isn't responding to treatment (refractory). 211At-BC8-B10 is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy and total body irradiation before a stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can attack the body's normal cells, called graft versus host disease. Giving cyclophosphamide, mycophenolate mofetil, and tacrolimus after a transplant may stop this from happening.",[340,313,341,314,315,317,82,316,319,318,320,342],"Acute Lymphoblastic Leukemia in Remission","Acute Myeloid Leukemia in Remission","Hematopoietic and Lymphoid Cell Neoplasm",[344,345,346],"Lymphoid Leukemia","Myeloid and Monocytic Leukemia","Other Hematopoietic","2026-06-17",{"date":155,"type":36},{"date":350,"type":36},"2019-07-10",{"date":352,"type":21},"2029-10-20",{"name":42,"class":43},{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":12,"sex":17,"minAge":361,"maxAge":362,"enrollmentInfo":363,"targetDuration":4,"studyType":22,"phases":364,"briefSummary":365,"conditions":366,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":260},"100641447","phase-2-naive-t-cell-deplete-grafts-for-gvhd-prevention-in-non-malignant-diseases-100641447","NCT07660783","Naive T Cell Deplete Grafts for GVHD Prevention in Non-Malignant Diseases","A Phase II Prospective Study Evaluating Selective Depletion of CD45RA+ (Naïve) T Cells (TND) From Peripheral Blood Stem Cell (PBSC) Grafts for Prevention of Graft Versus Host Disease (GVHD) in Non-Malignant Diseases (NMDs)","Inclusion Criteria:\n\n* Considered appropriate candidate for allogeneic HCT following low dose (4Gy) TBI containing-conditioning and have one of the following diagnoses: A) BMF B)Hemoglobinopathies C)PID D) Autoimmune cytopenias E) Immune dysregulation F) HLH G) Other NMD treatable by HCT and NMD that is not clearly defined (a patient with a NMD for whom genetic testing has been done and a genetic mutation responsible for their NMD phenotype has not been identified) are eligible for the study following discussion with and approval by the protocol PI\n* Patients aged 6 months- 5 years old (inclusive) at the time of informed consent\n* Patient with suitable HCT donor (see inclusion criteria below)\n* Recipient informed consent\u002Fassent (13 years and older), and\u002For legal guardian permission must be obtained\n\nExclusion Criteria:\n\n* Patient with aplastic anemia\n* Patients with severe combined immunodeficiency (SCID)\n* Fanconi anemia\n* Dyskeratosis congenita\n* Patient weight \\> 100 kg\n* Patients who are positive for HIV-1, HIV-2\n* Patients with current neoplastic disorders\n* Patients with uncontrolled infections for whom HCT is considered contraindicated by the consulting infectious disease physician.\n* Patients with organ dysfunction including A) Renal insufficiency B) Impaired cardiac function C)Impaired pulmonary function D) Liver dysfunction\n* Patients who are pregnant or breast-feeding\n* Patients on other experimental protocols for prevention of GVHD\n* Patients of childbearing age who are presumed to be fertile and are unwilling to use an effective birth control method or refrain from sexual intercourse during and for 12 months post-HCT\n* Patients with any other significant medical conditions that would make them unsuitable for transplantation, as determined by the PI\n* Patients with a known hypersensitivity to tacrolimus or MMF","6 Months","50 Years",{"count":75,"type":21},[55],"This phase II trial investigates how well a naive T cell depleted graft work for the reduction of graft versus host disease in patients with non-malignant diseases requiring hematopoietic cell transplantation. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.",[367,368,369,370,371,372,373],"Bone Marrow Failure","Hemoglobinopathies","Primary Immune Deficiency (PID)","Autoimmune Cytopenia","Immune Dysregulation","Hemophagocytic Lymphohistiocytosis (HLH)","Non Malignant Disorders","2026-06-16",{"date":155,"type":36},{"date":377,"type":21},"2026-09",{"date":379,"type":21},"2035-09",{"name":42,"class":43},{"id":382,"slug":383,"hasResults":12,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":4,"eligibilityCriteria":387,"healthyVolunteers":12,"sex":388,"minAge":18,"maxAge":4,"enrollmentInfo":389,"targetDuration":4,"studyType":22,"phases":391,"briefSummary":392,"conditions":393,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":397,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":44},"100510749","remotely-delivered-community-aligned-weight-loss-interventions-among-breast-cancer-survivors-vida-trial-100510749","NCT05930483","Remotely Delivered, Community-Aligned Weight Loss Interventions Among Breast Cancer Survivors, ¡Vida! Trial","Using a SMART Design to Evaluate Remotely Delivered, Community-aligned Weight Loss Interventions Among Breast Cancer Survivors: The ¡Vida! Study","Inclusion Criteria:\n\n* Biologically female\n* Age \\>= 18 years\n* Self-identifies Hispanic\u002FLatina\n* Able to read and write in Spanish and\u002For English\n* Previous diagnosis of stage I-III BC within the past 5 years\n* No evidence of current, recurrent, or metastatic disease\n* 60 days post treatment, including chemotherapy, radiation therapy, and cancer-related surgery (NOTE: current allowed therapies include endocrine therapy, CDK4\u002F6 inhibitors (e.g. palbociclib,ribociclib, abemaciclib), HER2-directed therapies (e.g., trastuzumab, neratinib), and monoclonal antibodies (e.g., pertuzumab, pembrolizumab); surgery for breast reconstruction is allowed during the trial)\n* Body mass index (BMI) \\>= 27 kg\u002Fm\\^2 initially assessed via self-reported height and weight and confirmed prior to randomization via a tape measure and Bluetooth-enabled scale\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* Willingness to participate in all study activities\n* Access to phone for study contacts\n* Access to internet to participate in the online program and to be able to sync study devices\n* Successful completion of at-home baseline assessments prior to randomization\n\nExclusion Criteria:\n\n* Body mass index (BMI) \\\u003C 27 kg\u002Fm\\^2 at time of baseline data collection\n* Diabetic with current use of insulin or sulfonylurea medications (note: current use of metformin is allowed)\n* Use of glucagon-like peptide-1 (GLP1) receptor agonist medications reported at baseline\n* Current use of cytotoxic chemotherapy medications (e.g., capecitabine) or drug-antibody conjugates (e.g., trastuzumab emtansine \\[T-DM1\\], trastuzumab deruxtecan \\[T-DXd\\])\n* Major comorbidities or physical limitations that would preclude from healthy weight loss, reducing energy intake or engaging in PA\n* Pregnant, breastfeeding, or planning to become pregnant during the study period\n* Use of exogenous hormones for gender affirmation\n* For stool sample collection only: Self-reported use of oral or intravenous antibiotics, antifungals, or anti-parasitics during the past 6 months\n* For stool sample collection only: Presence of self-reported ileostomy or colostomy\n* For stool sample collection only: Presence of self-reported inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis)\n* Anticipated major surgical procedure (e.g., hysterectomy) within 3 months after study registration. Breast reconstruction is allowed during study participation.\n* Concurrent enrollment in another weight loss or physical activity trial","FEMALE",{"count":390,"type":21},640,[24],"This clinical trial evaluates remotely delivered, community-aligned weight loss interventions in Latina breast cancer survivors. Breast cancer is the second leading cause of cancer death among women in the US. There are population differences in breast cancer mortality, based on specific risk factors, including obesity. Cancer is the leading cause of death among Latinos, and among Latinas, breast cancer is the leading cause of cancer death. An estimated 80% of Latinas in the United States have overweight\u002Fobesity, which is associated with poorer breast cancer outcomes. However, few, if any, effective interventions exist to promote and maintain weight loss in Latina breast cancer survivors. The development of an adaptive program that provides survivors with the support they need, as opposed to what is typically available, to improve breast cancer survivorship.",[394,395,396],"Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage III Breast Cancer AJCC v8",{"date":213,"type":36},{"date":399,"type":36},"2025-04-08",{"date":401,"type":21},"2028-03-01",{"name":42,"class":43},{"id":404,"slug":405,"hasResults":12,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":4,"eligibilityCriteria":409,"healthyVolunteers":121,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":410,"targetDuration":4,"studyType":22,"phases":411,"briefSummary":412,"conditions":413,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":44},"100614635","adapted-helping-ovarian-cancer-patients-cope-intervention-to-address-burnout-for-gynecologic-oncology-clinicians-100614635","NCT07282158","Adapted Helping Ovarian Cancer Patients Cope Intervention to Address Burnout for Gynecologic Oncology Clinicians","Adaptation of Helping Ovarian Cancer Patients Cope (HOPE) for Clinician Burnout (HOPE-C)","Inclusion Criteria:\n\n* Age 18 years of age or older\n* English speaking\n* Able to provide informed consent\n* Working with patients with ovarian cancer (gynecologic oncologists, medical oncologists, nurses, social workers, and advance practice providers \\[APPs\\])",{"count":7,"type":21},[24],"This clinical trial tests an adapted version of the Helping Ovarian Cancer Patients Cope (HOPE) intervention to address burnout among gynecologic oncology clinicians. Stress and burnout among gynecologic oncology clinicians can have far-reaching impacts not only on physicians at the individual level (e.g., distress, mental illness) but also at the professional (e.g., worse patient outcomes, increased errors) and societal levels (fewer physicians in this specialty, more system strain). The original Helping Ovarian Cancer Patients Cope (HOPE) is a workshop to promote hope among patients with ovarian cancer through creating positive narratives using the hope theory and social-cognitive theory. The adapted intervention for clinicals (HOPE-C) will use the same concepts but tailored to clinician experiences by fostering peer support and retelling their challenging stories and may address burnout for gynecologic oncology clinicians.",[414,415],"Ovarian Carcinoma","Psychiatric Disorder","2026-06-15",{"date":347,"type":36},{"date":419,"type":36},"2026-02-24",{"date":421,"type":21},"2029-12-31",{"name":42,"class":43},{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":430,"targetDuration":4,"studyType":22,"phases":431,"briefSummary":432,"conditions":433,"keywords":437,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":439,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":260},"100539045","high-intensity-exercise-and-high-fiber-diet-for-immunotherapy-outcomes-in-melanoma-patients-the-duo-trial-100539045","NCT06298734","High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial","Modulating Immune-Microbiome Axis Through High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial","Inclusion Criteria:\n\n* Age ≥18 years.\n* Histologically diagnosed with melanoma.\n* Having been or newly receiving immunotherapy for at least one month.\n* Having a plan to continue immunotherapy for at least 8 weeks at the time of recruitment.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2, indicating the ability to fulfill physical fitness and function assessments.\n* Ability to understand and willingness to provide informed consent.\n\nExclusion Criteria:\n\n* Participating in ≥ 150 minutes of moderate-to-vigorous aerobic exercise per week over the past month.\n* Consuming ≥ 30 grams\u002Fday of dietary fiber over the past month.\n* Having chronic medical conditions that are clinically unstable or uncontrolled with medications, deemed high-risk for exercise. These include but are not limited to unstable cardiac diseases, uncontrolled diabetes, and bone metastases with imminent risk of fracture.\n* Having a high risk for noncompliance with study procedures. This will be determined by the study team based on the history of missed oncology appointments (i.e., ≥3 no-shows in 6 months) and poor responsiveness during recruitment (i.e., ≥3 unreturned contacts).\n* Patients who are non-English speaking and cannot complete the participant surveys.",{"count":75,"type":21},[24],"The purpose of this study is to determine whether high-intensity exercise and high-fiber diet are feasible and improve various health outcomes among participants with advanced melanoma receiving immunotherapy.\n\nThe names of the groups in this research study are:\n\n* High-Intensity Exercise (EX)\n* High-fiber Diet (DT)\n* Combined High-Intensity Exercise and High-Fiber Diet (COMB)\n* Attention Control (AC)",[434,435,436],"Melanoma (Skin)","Skin Cancer","Advanced Melanoma",[438,435,436],"Melanoma",{"date":347,"type":36},{"date":441,"type":36},"2024-07-01",{"date":443,"type":21},"2027-03-31",{"name":42,"class":43},{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":22,"phases":454,"briefSummary":455,"conditions":456,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":457,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":44},"100519451","phase-1-autologous-cd8-and-cd4-transgenic-t-cells-expressing-high-affinity-krasg12v-mutation-specific-t-cell-receptors-fh-a11krasg12v-tcr-in-treating-patients-with-metastatic-solid-tumor-cancers-with-kras-g12v-mutations-100519451","NCT06043713","Autologous CD8+ and CD4+ Transgenic T Cells Expressing High Affinity KRASG12V Mutation-Specific T Cell Receptors (FH-A11KRASG12V-TCR) in Treating Patients With Metastatic Solid Tumor Cancers With KRAS G12V Mutations","Phase I Study of Autologous CD8+ and CD4+ Transgenic T Cells Expressing High Affinity KRASG12V Mutation-Specific T Cell Receptors in Participants With Metastatic Solid Tumors With KRAS G12V Mutations","Inclusion Criteria:\n\n* LEUKAPHERESIS: Diagnosis of metastatic solid tumor\n* LEUKAPHERESIS: Tissue confirmation of solid tumor. Confirmation of diagnosis must be or have been performed by internal pathology review of archival biopsy material or other pathologic material at Fred Hutch\u002FUniversity of Washington Cancer Consortium (UWMC)\n* LEUKAPHERESIS: HLA-A\\*11:01 confirmed through HLA typing at a clinically accredited laboratory\n* LEUKAPHERESIS: Previously documented KRASG12V mutation in tumor or plasma cell-free deoxyribonucleic acid (cfDNA) specimens by polymerase chain reaction (PCR) or next-generation sequencing (NGS) test\n* LEUKAPHERESIS: Measurable disease by RECIST 1.1 criteria: Participants must have measurable disease, defined as at least one target lesion that can be measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm, unless lymph node in which case short axis must be ≥ 15 mm. Baseline imaging (for example, diagnostic CT chest\u002Fabdomen\u002Fpelvis and imaging of the affected extremity as appropriate), brain imaging (MRI or CT scan) if clinically indicated, must be obtained within 8 weeks of the first planned T cell infusion. MRI can be substituted for CT in participants unable to have CT contrast\n* LEUKAPHERESIS: Participants must be willing to undergo tumor biopsy for research purposes if safe and feasible at baseline (prior to first T cell infusion), 2-3 weeks after the first T cell infusion, and approximately 2 weeks +\u002F- 1 week after the 2nd infusion (if applicable), if safe and feasible (these time windows may vary due to manufacturing or clinical reasons). Should there be no tumor tissue that is accessible for biopsy, subjects will still be considered for participation, at the discretion of the investigator. Similarly, should an investigator determine that a biopsy cannot be performed safely for clinical reasons, biopsies may be cancelled or rescheduled. Patients can also refuse biopsies at any time after enrollment\n* LEUKAPHERESIS: Participants must be at least two weeks or five half-lives (for small molecules) from last systemic treatment: At least 2 weeks must have passed since any: immunotherapy (for example, T-cell infusions, immunomodulatory agents, interleukins, vaccines), or chemotherapy cancer treatment. At least five half-lives must have passed from treatment with small molecules or other investigational agents. There is no washout period for radiation, so long as radiated lesion is not the lesion being evaluated for RECIST measurements on the protocol. Bisphosphonates and denosumab are permitted\n* LEUKAPHERESIS: Participants must have progressed on or be intolerant to at least one lines of prior therapy including any targeted therapies indicated for subjects with each of the tumor types eligible to enroll, as applicable\n* LEUKAPHERESIS: Patients with solid tumors harboring targetable molecular alterations including but not limited to EGFR mutations, ALK, ROS, NTRK fusions, microsatellite instability (MSI)-high, tumor mutational burden (TMB) high, BRAF v600 mutations, HER2 amplifications, must have been treated or refused treatment with applicable targeted therapies, as applicable\n* LEUKAPHERESIS: Fertile male and female participants must be willing to use an effective contraceptive method before, during, and for at least 4 months after the last A11KRASG12V-TCR infusion\n* LEUKAPHERESIS: 18 years or older at the time of enrollment\n* LEUKAPHERESIS: Capable of understanding and providing a written informed consent\n* LEUKAPHERESIS: Eastern Cooperative Oncology Group (ECOG) performance status of =\\\u003C 1\n\n  * No uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once every 28 days\n* LEUKAPHERESIS: No uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once every 28 days\n* LEUKAPHERESIS: Renal: Creatinine clearance \\>= 50 ml\u002Fmin by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) or 24-hour urine clearance\n* LEUKAPHERESIS: Hepatic: Total bilirubin \\\u003C 2.0 mg\u002FdL\n* LEUKAPHERESIS: Hepatic: Aspartate transferase (AST) and alanine transaminase (ALT) \\\u003C 5x upper limit of normal (ULN)\n* LEUKAPHERESIS: Hepatic: Participants with suspected Gilbert syndrome may be included if total bilirubin (Bili) \\> 3 mg\u002FdL but no other evidence of hepatic dysfunction\n* LEUKAPHERESIS: Cardiac: Participants 60 years of age or older are required to have left ventricular ejection fraction (LVEF) evaluation performed within 60 days prior to enrollment. LVEF may be established with echocardiogram or MUGA scan, and LVEF must be \\>= 35%. Cardiac evaluation for other participants is at the discretion of the treating physician\n* LEUKAPHERESIS: Hematologic: Absolute neutrophil count (ANC) \\>= 1000 cells\u002F mm\\^3\n* LEUKAPHERESIS: Nutrition: Albumin \\>= 3 g\u002FdL\n* START OF TREATMENT: Measurable disease by RECIST 1.1 criteria: Participants must have measurable disease, defined as at least one target lesion that can be measured in at least one dimension (longest diameter to be recorded) as \\>= 10 mm, unless lymph node in which case short axis must be \\>= 15 mm. Baseline imaging (for example, diagnostic CT chest\u002Fabdomen\u002Fpelvis and imaging of the affected extremity as appropriate), brain imaging (MRI or CT scan) must be obtained within 8 weeks of the first planned T cell infusion. MRI can be substituted for CT in participants unable to have CT contrast\n* START OF TREATMENT: Participants must be willing to undergo tumor biopsy for research purposes if safe and feasible at baseline (prior to first T cell infusion), 2-3 weeks after the first T cell infusion, and approximately 2 weeks +\u002F- 1 week after the 2nd infusion (if applicable), if safe and feasible (these windows may vary due to manufacturing or clinical reasons). Should there be no tumor tissue that is accessible for biopsy, subjects will still be considered for participation, at discretion of the investigator. Similarly, should an investigator determine that a biopsy cannot be performed safely for clinical reasons, biopsies may be cancelled or rescheduled\n* START OF TREATMENT: Participants must be at least two weeks from last systemic treatment: At least 2 weeks must have passed since any: immunotherapy (for example, T-cell infusions, immunomodulatory agents, interleukins, vaccines), or chemotherapy cancer treatment. At least five half-lives must have passed from treatment with small molecules or other investigational agents. There is no washout period for radiation, so long as radiated lesion is not the lesion being evaluated for RECIST measurements on the protocol. Bisphosphonates and denosumab are permitted\n* START OF TREATMENT: ECOG performance status of =\\\u003C 1\n* START OF TREATMENT: Renal: Creatinine clearance \\>= 50 ml\u002Fmin by CKD-EPI or 24-hour urine clearance\n\n  * Exceptions may be at the discretion of the PI to allow participants with organ function affected by their organ-specific tumor involvement\n* START OF TREATMENT: Hepatic: Total bilirubin \\\u003C 2.0 mg\u002FdL\n\n  * Exceptions may be at the discretion of the PI to allow participants with organ function affected by their organ-specific tumor involvement\n* START OF TREATMENT: AST and ALT \\\u003C 5x upper limit of normal (ULN)\n* START OF TREATMENT: Participants with suspected Gilbert syndrome may be included if total Bili \\> 3 mg\u002Fdl but no other evidence of hepatic dysfunction\n* START OF TREATMENT: Pulmonary: =\\\u003C grade 1 dyspnea and oxygen saturation of arterial blood (SaO2) \\>= 92% on ambient air. If pulmonary function tests (PFTs) are performed based on the clinical judgement of the treating physician, participants with forced expiratory volume in the first second (FEVI) \\>= 50% of predicted and diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected) \\>= 40% of predicted will be eligible\n\n  * Exceptions may be at the discretion of the PI to allow participants with organ function affected by their organ-specific tumor involvement\n* START OF TREATMENT: Hematologic: ANC \\>= 1000 cells\u002F mm\\^3\n\n  * Exceptions may be at the discretion of the PI to allow participants with organ function affected by their organ-specific tumor involvement\n* START OF TREATMENT: Nutrition: Albumin \\>= 3 g\u002FdL\n\n  * Exceptions may be at the discretion of the PI to allow participants with organ function affected by their organ-specific tumor involvement\n* START OF TREATMENT: Participants with a history of chronic obstructive pulmonary disease (COPD), emphysema, or greater than 30 pack year smoking history should undergo PFTs and meet the following criteria:\n\n  * FEVI \\>= 50% of predicted and DLCO (corrected) \\>= 40% of predicted will be eligible\n\nExclusion Criteria:\n\n* LEUKAPHERESIS: Prior solid organ transplant or allogeneic hematopoietic stem cell transplant: Kidney transplant participants will be considered on a case-by-case basis requiring discussion with PI. If the participant has had a kidney transplant, participant must have dialysis access, dialysis plan, supportive nephrologist, willingness to stop transplant immunosuppression, and express understanding that rejection is possible outcome. Dialysis or costs related to transplant kidney will not be supported by the study. Participants having had any other solid organ transplants will be excluded, as will those with any history of allogeneic hematopoietic stem cell transplant\n* START OF TREATMENT: Pregnancy, breastfeeding, or expecting to conceive or father children for the duration of the trial through 4 months after last T-cell infusion. Participants of childbearing potential must have a negative serum pregnancy test within the 2 weeks (14 days) preceding T cell infusion. Childbearing potential is defined as women who have not been surgically sterilized and who are not post-menopausal (free of menses for at least 1 year)\n* START OF TREATMENT: Active autoimmune disease: Participants with active autoimmune disease requiring immunosuppressive therapy are excluded. Case by case exemptions are possible with approval by PI\n* START OF TREATMENT: Corticosteroid therapy at a dose equivalent of \\> 0.5 mg\u002Fkg of prednisone per day. The following treatments are permitted: intranasal, inhaled, topical, or local steroid applications; systemic corticosteroids at physiologic doses equivalent to no more than \\> 0.5 mg\u002Fkg\u002Fday prednisone; steroids as premedication for contrast dye allergy\n* START OF TREATMENT: Concurrent use of other investigational anti-cancer agents\n* START OF TREATMENT: Active uncontrolled infection: Human immunodeficiency virus (HIV) positive participants on highly active antiretroviral therapy (HAART) with a CD4 count \\> 500 cells\u002Fmm\\^3 are considered controlled, as are individuals with a history of hepatitis C who have successfully completed antiviral therapy with an undetectable viral load, and those with hepatitis B who have hepatitis well controlled on medication\n* START OF TREATMENT: Uncontrolled concurrent illness: Participants may not have uncontrolled or concurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* START OF TREATMENT: Untreated brain metastases: Participants with small asymptomatic brain metastases (\\\u003C 1 cm) or those with brain metastases previously treated and controlled with surgery or radiotherapy will be considered for inclusion at discretion of PI, so long as all other eligibility criteria are met\n* START OF TREATMENT: Active treatment for prior immune related adverse event to any immunotherapy: Participants receiving ongoing treatment for prior serious immune-related adverse events are excluded, with exception of hormone supplementation or corticosteroid therapy at equivalent of up to 0.5mg\u002Fkg\u002Fday prednisone per day, unless otherwise approved by PI\n* START OF TREATMENT: Other medical, social, or psychiatric factor that interferes with medical appropriateness and\u002For ability to comply with study, as determined by the PI\n* START OF TREATMENT: Known allergic reactions to any of the components of study treatments\n* START OF TREATMENT: Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once every 28 days",{"count":453,"type":21},24,[77],"This phase I trial studies the side effects and best dose of autologous CD8+ and CD4+ transgenic T cells expressing high affinity KRASG12V mutation-specific T cell receptors (FH-A11KRASG12V-TCR) and to see how well they work in treating patients with solid tumor cancers that has spread from where it first started (primary site) to other places in the body (metastatic). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize KRAS G12V, a protein on the surface of tumor cells. These KRAS G12V-specific T cells may help the body's immune system identify and kill KRAS G12V solid cancer tumor cells.",[128],{"date":347,"type":36},{"date":459,"type":36},"2023-12-15",{"date":461,"type":21},"2028-01-01",{"name":42,"class":43},{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":470,"enrollmentInfo":471,"targetDuration":4,"studyType":22,"phases":472,"briefSummary":473,"conditions":474,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":476,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":44},"100368889","phase-1-total-body-irradiation-and-astatine-211-labeled-bc8-b10-monoclonal-antibody-for-the-treatment-of-nonmalignant-diseases-100368889","NCT04083183","Total Body Irradiation and Astatine-211-Labeled BC8-B10 Monoclonal Antibody for the Treatment of Nonmalignant Diseases","Targeted Astatine-211-Labeled BC8-B10 Monoclonal Antibody as Reduced Intensity Conditioning for Nonmalignant Diseases","Inclusion Criteria:\n\n* Age \\>= 18 years and \\\u003C 50 years\n* Nonmalignant disease treatable by allogeneic hematopoietic cell transplantation (HCT). Patients with a nonmalignant disease that is not clearly defined must be approved by the principal investigator (PI)\n* Karnofsky score \\>= 70\n* Patients must have normal elastography\n* If ferritin is elevated, patient must have less than 7 mg\u002Fg liver iron concentration on liver T2 magnetic resonance imaging (MRI)\n* Patients should have an official gastrointestinal (GI) consult prior to the transplant for full evaluation\n* DONOR INCLUSION\n* HLA matched related donor that is genotypically or phenotypically identical for HLA-A, -B, -C, -DRB1, -DQB1. Phenotypic identity must be confirmed by high-resolution typing. Sibling donors are preferred over other relationships\n* Unrelated donor.\n\n  * Matched for HLA-A, -B, -C, -DRB1, and DQB1 by high-resolution typing; OR\n  * Mismatched for a single HLA-class 1 allele or HLA-DQB1 antigen or allele by high-resolution typing.\n\nNote: A donor homozygous for one allele only at HLA-A, B, C, DRB1, or DQB1 is allowed (1 antigen mismatch for graft versus host disease \\[GVHD\\], 0 antigen mismatch for graft-rejection). In the case of a recipient who is homozygous at one locus, the mismatch is not allowed to be at that locus (0 antigen mismatch for GVHD, 1 antigen mismatch for graft-rejection)\n\n* HLA haploidentical donor. There must be one shared HLA-haplotype based on inheritance. The noninherited haplotype is allowed to be mismatched at any or all of these loci: HLA-A, B, C, DRB1 or DQB1.\n* Donor selection guideline recommendations: in the case where there are multiple donor options, donors should be selected based on the following priority numbered below:\n\n  * Related donor genotypically HLA-matched\n  * Related donor phenotypically HLA-matched\n  * Unrelated donor HLA-matched\n  * Unrelated donor with single allele level mismatch at class 1 (HLA-A, -B, or -C). For example, HLA-A02:01 versus HLA-A 02:02\n  * Unrelated donor with single allele level mismatch at DQB1\n  * HLA-haploidentical donor Note: We require that the donor testing be performed by a United States Clinical Laboratory Improvement Amendment (CLIA) approved laboratory. In the very rare case where the donor testing is not able to be performed in a CLIA approved laboratory, or there is confirmatory testing that needs to be performed, or for any donor identified from Europe and at risk for Creutzfeldt-Jakob Disease (CJD), we note this on the donor screening form and require that the unrelated donor medical director or the attending physician approves the use of the donor HPC-A product under urgent medical need\n\nExclusion Criteria:\n\n* Patients with Fanconi Anemia\n* Impaired cardiac function as evidenced by ejection fraction \\\u003C 35% (or, if unable to obtain ejection fraction, shortening fraction of \\\u003C 26%) or cardiac insufficiency requiring treatment or symptomatic coronary artery disease. Patients with a shortening fraction of \\\u003C 26% may be enrolled if approved by a cardiologist. In addition, patients with poorly controlled hypertension on multiple anti-hypertensive medications, symptomatic coronary artery disease, or patients on cardiac medications for antiarrhythmic or inotropic effects are excluded\n* Impaired pulmonary function as evidenced by carbon monoxide diffusing capability test (DLCO) \\\u003C 35% of predicted or receiving supplemental continuous oxygen. In addition, if patients are unable to perform pulmonary function tests, then O2 saturation \\\u003C 92% on room air\n* Impaired renal function as evidenced by estimated creatinine clearance less than 50 ml\u002Fmin or serum creatinine \\> 2 x upper normal limit or dialysis-dependent. Serum creatinine value must be within 28 days prior to start of conditioning\n\n  \\* The creatinine clearance may be estimated by the Cockcroft-Gault formula\n* Impaired liver function as evidenced by abnormal hepatic function within 2 months prior to the astatine-211 infusion date defined as a total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) \\> 2 times the upper limit of normal (with the exception of elevated total bilirubin level, predominantly indirect bilirubin, in patients with hemoglobinopathy due to acute and\u002For chronic hemolysis). In addition, patients with the following liver abnormalities are excluded: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease\n* An uncontrolled infection requiring deferral of conditioning as recommended by an infectious disease specialist. A viral upper respiratory tract infection does not constitute an uncontrolled infection in this context\n* Patients who are known to be positive for HIV (human immunodeficiency virus)\n* Women of childbearing potential who are pregnant or breast-feeding\n* Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment\n* Allergy to murine-based monoclonal antibodies\n* Known contraindication to radiotherapy\n* DONOR EXCLUSION\n* Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment. The recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain panel reactive antibody (PRA) screens to class I and class II antigens for all patients before hematopoietic cell transplantation (HCT). If the PRA shows \\> 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained. The donor should be excluded if any of the cytotoxic cross match assays are positive. For those patients with an HLA class I allele or class II allele or antigen mismatch or haploidentical donors, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results. A positive anti-donor cytotoxic crossmatch is an absolute donor exclusion","49 Years",{"count":75,"type":21},[77,55],"This phase I\u002FII trial studies the best dose of total body irradiation with astatine-211 BC8-B10 monoclonal antibody for the treatment of patients with nonmalignant diseases undergoing hematopoietic cell transplant. Radiation therapy uses high energy gamma rays to kill cancer cells and shrink tumors. Astatine-211-labeled BC8-B10 monoclonal antibody is a monoclonal antibody, called anti-CD45 monoclonal antibody BC8-B10, linked to a radioactive\u002Ftoxic agent called astatine 211. Anti-CD45 monoclonal antibody BC8-B10 is attached to CD45 antigen positive cancer cells in a targeted way and delivers astatine 211 to kill them. Giving astatine-211 BC8-B10 monoclonal antibody and total-body irradiation before a donor stem cell transplant may help stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells.",[475],"Non-Malignant Neoplasm",{"date":347,"type":36},{"date":478,"type":36},"2020-06-16",{"date":480,"type":21},"2028-01-09",{"name":42,"class":43},{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":121,"sex":17,"minAge":362,"maxAge":489,"enrollmentInfo":490,"targetDuration":4,"studyType":22,"phases":491,"briefSummary":492,"conditions":493,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":501,"locationsCount":44},"100630683","a-restorative-justice-based-lung-cancer-screening-decision-making-support-intervention-tailored-for-black-individuals-to-increase-lung-cancer-screening-among-black-community-members-restore-trial-100630683","NCT07490860","A Restorative Justice-Based Lung Cancer Screening Decision-Making Support Intervention Tailored for Black Individuals to Increase Lung Cancer Screening Among Black Community Members, RESTORE Trial","Integrating Restorative Practices to Enhance Shared Decision-Making and Uptake of Lung Cancer Screening in Black Community Members (RESTORE)","Inclusion Criteria:\n\n* Identify as Black or African American\n* Between ages 50-77\n* Self-reported 20-pack year smoking history\n* Ongoing commercial tobacco use within the past 15 years\n* Proficiency in the English language\n\nExclusion Criteria:\n\n* Has a documented chest CT within the past one year\n* Personal history of lung cancer or symptoms associated with lung cancer","77 Years",{"count":227,"type":21},[24],"This clinical trial develops and studies whether a restorative justice-based lung cancer screening (LCS) decision-making support intervention tailored for Black individuals increases LCS among Black community members. Lung cancer remains the leading cause of cancer deaths among Black men and women. LCS with yearly low-dose chest computed tomography (CT) is recommended for people with current or recent tobacco use (within 15 years) who are aged 50-80 with at least a 20 pack-year smoking history. LCS lowers lung cancer death by 20%; however, data shows that LCS completion remains low among minority groups in the United States. The restorative justice-based LCS decision-making support intervention in this trial has been specifically tailored to meet the needs of Black individuals. It is designed to reduce racial unfairness by promoting trust, shared understanding, and empowerment in clinical decision making while addressing the social and historical circumstances of health inequalities. This may be an effective way to increase LCS among Black community members.",[494],"Lung Carcinoma","2026-06-10",{"date":497,"type":36},"2026-06-12",{"date":499,"type":21},"2026-07-01",{"date":139,"type":21},{"name":42,"class":43},{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":4,"eligibilityCriteria":508,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":509,"targetDuration":4,"studyType":22,"phases":510,"briefSummary":511,"conditions":512,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":515,"startDateStruct":516,"completionDateStruct":517,"leadSponsor":519,"locationsCount":44},"100600227","randomization-for-the-identification-of-best-treatment-intensity-for-less-fit-adults-with-acute-myeloid-leukemia-and-myeloid-neoplasms-100600227","NCT07094750","Randomization for the Identification of Best Treatment Intensity for Less Fit Adults With Acute Myeloid Leukemia and Myeloid Neoplasms","Impact of Treatment Intensity on Survival, Quality of Life, and Resource Utilization in Medically Less Fit Adults With Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms: A Randomized Pilot Study","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of high grade myeloid neoplasm (\\> 10% blasts in blood or marrow), other than acute promyelocytic leukemia (APL) according to the 2022 International Consensus Classification (ICC) classification. Patients with acute leukemias of ambiguous lineage are eligible\n* The use of cytoreductive therapy before treatment is permitted. Patients with symptoms\u002Fsigns of leukostasis, white blood cell (WBC) \\> 100,000\u002FμL, or acute symptoms that in the opinion of the treating physician are likely related to their high-grade myeloid neoplasm may receive up to 2 doses of cytarabine (up to 500 mg\u002Fm\\^2 each) prior to study day 1\n* Patients may have received treatment for antecedent low-grade myeloid neoplasm (\\\u003C 10% myeloid blasts on blood or bone marrow)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3 (for patients aged \\\u003C 75 years) or ECOG performance status of 0 - 2 (for patients aged ≥ 75 years)\n* The presence of one or more of the following criteria for 'unfitness'. (Patients without respiratory symptoms at rest are eligible and should only complete spirometry\u002Fdiffusion capacity of the lung for carbon monoxide \\[DLCO\\] measurements as clinically indicated):\n\n  * ECOG Performance Status of 2 or 3\n  * Cardiac history of congestive heart failure (CHF) requiring treatment or ejection fraction ≤ 50% or chronic stable angina\n  * Documented DLCO ≤ 65% or forced expiratory volume in 1 second (FEV1) ≤ 65%; or dyspnea at rest, or requiring supplemental oxygen\n  * Creatinine clearance ≥ 30 mL\u002Fmin to \\\u003C 45 ml\u002Fmin\n  * Moderate hepatic impairment with total bilirubin \\> 1.5 to ≤ 3.0 × upper limit of normal (ULN)\n  * Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy\n* Adequate cardiac function:\n\n  * Patients aged ≤ 60 years without a history of cardiac disease or evidence of heart failure are eligible if they also exhibit the following:\n\n    * Chest x-ray (CXR) without evidence of moderate or severe pulmonary edema or pleural effusion, and a normal cardio-mediastinal silhouette\n    * Electrocardiogram (ECG) without evidence of atrial or ventricular chamber enlargement\n    * Note that patients with either abnormal CXR or ECG should have a structural heart assessment (echocardiogram, multigated acquisition scan \\[MUGA\\] or similar) and are eligible if left ventricular ejection fraction (LVEF) \\> 40% and the abnormalities in the CXR\u002FECG do not preclude safe administration of intensive chemotherapy\n  * Patients with a documented left ventricular ejection fraction (LVEF) ≥ 40%, assessed within 3 months prior to registration, e.g. by MUGA scan or echocardiography, or another appropriate diagnostic modality are eligible\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x ULN, unless judged due to leukemic organ involvement\n* Total bilirubin ≤ 3 x ULN unless judged due to leukemic organ involvement, Gilbert's syndrome, or hemolysis\n* Women of childbearing potential and men must agree to use adequate contraception beginning at the signing of the consent until at least 4 weeks after the last dose of study drug\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Known hypersensitivity to cytarabine, anthracycline, hypomethylating agents, or venetoclax\n* Cardiovascular disability status of New York Heart Association class ≥ 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or anginal pain\n* Subject exhibits evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial or fungal)\n* Concomitant illness associated with a likely survival of \\\u003C 1 year\n* Active pregnancy or breast feeding",{"count":20,"type":21},[24],"This clinical trial studies whether less fit adults with acute myeloid leukemia (AML) or myeloid neoplasms are willing to let a computer program decide (randomization) whether they receive lower- or higher-intensity chemotherapy. Historically, treatment decision-making for patients with AML or myeloid neoplasms has divided patients into two categories, with patients considered fit receiving intensive \"curative\" chemotherapy, and patients considered unfit, such as older patients with a higher risk of early death from therapy, receiving non-intensive \"palliative\" therapy or no therapy. With the introduction of new treatment agents, it has become difficult to determine the difference between intensive and non-intensive therapy, especially for patients considered unfit for whom treatment-related side effects remain a concern. Treatment intensity is best identified through randomized trials but often patients are unwilling to undergo randomization due to preset beliefs. However, with improved supportive care and the awareness that new treatment agents may have similar risks as intensive therapy, it may be possible that more patients are willing to be randomized. This may help identify the best treatment intensity for less fit adults with AML or myeloid neoplasms, which may improve outcomes.",[513,80,514],"Acute Leukemia of Ambiguous Lineage","Myeloid Neoplasm",{"date":497,"type":36},{"date":499,"type":21},{"date":518,"type":21},"2029-06-08",{"name":42,"class":43},{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":388,"minAge":527,"maxAge":470,"enrollmentInfo":528,"targetDuration":4,"studyType":22,"phases":530,"briefSummary":531,"conditions":532,"keywords":537,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":544,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":44},"100642783","feasibility-study-comparing-one-vs-two-probes-for-thermal-ablation-among-cervical-cancer-screen-positive-wlwh-in-c1001p-cs9-south-africa-100642783","NCT07645378","Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive WLWH in C1001P-CS9 South Africa","Expanded Use of Thermal Ablation (EXCEL Cohort) and Prophylactic Use of Two Probes (PRO Cohort) for Cervical Cancer Prevention in Women Living With HIV","Inclusion Criteria:\n\n1. 25-49 years old\n2. Living with HIV\n\nInclusion criteria specific to the feasibility study\n\n1. Intact cervix\n2. Willing to return to facility at 6 months\n3. Willing and able to provide informed consent\n4. Positive hrHPV or VIA test within 3 months of enrollment\n5. Type 1 transformation zone (TZ1)\n6. Thermal ablation eligible\n\nExclusion Criteria:\n\n1. Screened for cervical cancer outside of study in last 6 months\n2. Currently pregnant or less than 6 weeks postpartum\n3. Prior diagnosis of cervical cancer\n4. A history of treatment for cervical precancer\n5. Total hysterectomy\n6. Currently receiving treatment for any cancer\n7. Individual has a condition that the Clinical Site PI believes will interfere with or affect the conduct, results, or completion of the clinical study\n8. Individual has a condition that the Clinical Site PI considers creates an unacceptable risk to the individual if enrolled","25 Years",{"count":529,"type":21},200,[24],"Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), particularly women living with HIV (WLWH) who have a 6-fold increased risk of cervical cancer compared to women in the general population. Thermal ablation (TA) is recommended by the World Health Organization (WHO) to treat cervical precancerous lesions, although its efficacy can be suboptimal in WLWH. The proposed study will evaluate the feasibility, acceptability, and safety of a two-probe TA technique (endocervical and ectocervical probes) and whether this approach improves treatment outcomes among WLWH compared to one (ectocervical) probe. This innovation has the potential to significantly enhance cervical cancer prevention efforts in high-burden settings. It will also contribute towards achieving the 90-70-90 goals of the WHO strategy for accelerated elimination of cervical cancer as a public health problem by 2030.",[533,534,535,536],"HIV (Human Immunodeficiency Virus)","HPV","Cervical Precancer","Cervical Neoplasia",[538,539,540,541,542],"HIV","Cervical cancer screening","Treatment of Cervical Precancer","Thermal ablation","Human papillomavirus","2026-06-09",{"date":497,"type":36},{"date":546,"type":21},"2026-06",{"date":548,"type":21},"2027-05-31",{"name":42,"class":43},{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":388,"minAge":527,"maxAge":470,"enrollmentInfo":555,"targetDuration":4,"studyType":22,"phases":557,"briefSummary":558,"conditions":559,"keywords":560,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":561,"startDateStruct":562,"completionDateStruct":563,"leadSponsor":564,"locationsCount":44},"100643388","feasibility-study-comparing-one-vs-two-probes-for-thermal-ablation-among-cervical-cancer-screen-positive-women-living-with-hiv-in-c1001p-cs7-zimbabwe-100643388","NCT07645352","Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive Women Living With HIV in C1001P-CS7 Zimbabwe",{"count":556,"type":21},300,[24],"Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), particularly women living with HIV (WLWH) who have a 6-fold increased risk of cervical cancer compared to women in the general population. While thermal ablation (TA) is a WHO- recommended treatment for cervical precancerous lesions, its efficacy can be suboptimal in WLWH. We will also conduct a feasibility treatment cohort study of up to 300 Zimbabwean WLWH to provide evidence for a larger treatment effectiveness study. The proposed study will evaluate the feasibility, acceptability, and safety of a two-probe TA technique (endocervical and ectocervical probes) and whether this approach improves treatment outcomes among WLWH compared to one (ectocervical) probe. This innovation has the potential to significantly enhance cervical cancer prevention efforts in high-burden settings and to contribute towards achieving the 90-70-90 goals of the World Health Organization's (WHO) strategy for accelerated elimination of cervical cancer as a public health problem by 2030.",[533,534,535,536],[538,539,540,541,542],{"date":497,"type":36},{"date":546,"type":21},{"date":548,"type":21},{"name":42,"class":43},{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":4,"eligibilityCriteria":571,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":572,"targetDuration":4,"studyType":22,"phases":574,"briefSummary":575,"conditions":576,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":577,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":44},"100642307","phase-1-fh-wt1-e50-tcr-t-cells-with-azacitidine-for-the-treatment-of-minimal-residual-disease-positive-acute-myeloid-leukemia-100642307","NCT07645469","FH-WT1-E50 TCR T Cells With Azacitidine for the Treatment of Minimal Residual Disease Positive Acute Myeloid Leukemia","Phase I Study of Autologous CD4+ and CD8+ T Cells That Have Been Transduced to Express a WT1-Specific T Cell Receptor for Treatment of MRD-Positive AML","Inclusion Criteria for Leukapheresis:\n\n* LEUKAPHERESIS: Age 18 years or older at the time of enrollment\n* LEUKAPHERESIS: Confirmed diagnosis of AML that is not M3 subtype (acute promyelocytic leukemia \\[APL\\])\n* LEUKAPHERESIS: Human leukocyte antigen (HLA) type HLA-A\\*02:01 confirmed through HLA typing\n* LEUKAPHERESIS: Tissue confirmation of WT1 expression by immunohistochemistry. Confirmation of diagnosis must be or have been performed by internal pathology review of archival biopsy material or other pathologic material at Fred Hutch\u002FUniversity of Washington Medical Center (UWMC)\n* LEUKAPHERESIS: Capable of understanding and willing to provide informed consent\n* LEUKAPHERESIS: Fertile male and female participants must be willing to use an effective contraceptive method before, during, and for at least 4 months after the last FH-WT1-E50 TCR T infusion\n* LEUKAPHERESIS: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 or Karnofsky Performance Status (KPS) ≥ 60%\n* LEUKAPHERESIS: No immediate plan for allogeneic stem cell transplantation: patients must not have a planned allogeneic hematopoietic stem cell transplant (HCT) within 8 weeks of leukapheresis. Patients may still be considered for HCT in the future but must not have a scheduled transplant at the time of enrollment due to factors including, but not limited to, donor availability, performance status, comorbidities, or patient preference. Patients who subsequently become candidates for HCT (e.g., donor identified or improvement in performance status) may proceed to transplant at the discretion of the treating physician without a mandated waiting period related to study participation\n* LEUKAPHERESIS: Creatinine clearance ≥ 30 ml\u002Fmin by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) or 24-hour urine clearance\n* LEUKAPHERESIS: Total bilirubin \\\u003C 3.0 mg\u002FdL. Participants with suspected Gilbert syndrome may be included if total bilirubin (tBili) \\> 3mg\u002FdL but no other evidence of hepatic dysfunction\n* LEUKAPHERESIS: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 5 x upper limit of normal (ULN)\n* LEUKAPHERESIS: Participants 60 years of age or older are required to have left ventricular ejection fraction (LVEF) evaluation performed within 60 days prior to enrollment. LVEF may be established with echocardiogram or MUGA scan, and left ejection fraction must be ≥ 35%. Cardiac evaluation for other participants is at the discretion of the treating physician\n\nInclusion Criteria at Start of Treatment:\n\n* START OF TREATMENT: Presence of Measurable Residual Disease (MRD) after chemotherapy at the time of screening. Patients must have achieved a morphologic remission (marrow that is at least 10% cellular with \\\u003C 5% blasts on morphologic review) with detectable MRD, regardless of incomplete recovery of neutrophil counts\u002Fless than 1,000\u002Fmm3 (CRi) or platelet counts less than 100,000\u002Fmm3 (CRp).\n\n  * MRD definition:\n\n    * MRD by flow cytometry: defined by any abnormal myeloid blasts identified by flow cytometric analysis.\n    * Molecular measurable residual disease (MRD): for patients with NPM1-mutated disease, we will incorporate a clinically validated quantitative NPM1 MRD assay performed at Fred Hutch. For patients with FLT3-ITD-mutated disease, MRD assessment will include a clinically validated FLT3-ITD assay performed at Invivoscribe. These assays are routinely used in clinical practice and have established performance.\n* START OF TREATMENT: Participants must be willing to undergo serial tumor biopsies and\u002For aspirates for research purposes if safe and feasible at baseline (prior to first T cell infusion), 2-3 weeks after the first T cell infusion, and approximately 2 weeks +\u002F- 1 week after the second infusion (if applicable) (these windows may vary due to manufacturing or clinical reasons). Should there be no marrow tissue that is accessible, participants will still be considered for participation, at the discretion of the investigator. Similarly, should an investigator determine that a marrow assessment cannot be performed safely for clinical reasons, those may be cancelled or rescheduled. Participants must be at least two weeks or five half lives (for small molecules) from last systemic treatment: At least 2 weeks must have passed since any: immunotherapy (for example, T cell infusions, immunomodulatory agents, interleukins, vaccines), or chemotherapy cancer treatment. At least five half-lives must have passed from treatment with small molecules or other investigational agents\n* START OF TREATMENT: ECOG performance status of 0, 1, or 2 or Karnofsky Performance Status (KPS) ≥ 60%\n* START OF TREATMENT: Creatinine clearance ≥ 30 ml\u002Fmin by CKD-EPI or 24-hour urine clearance\n* START OF TREATMENT: Total bilirubin \\\u003C 3.0 mg\u002FdL. Participants with suspected Gilbert syndrome may be included if tBili \\> 3mg\u002FdL but no other evidence of hepatic dysfunction.\n* START OF TREATMENT: Participants 60 years of age or older are required to have left ventricular ejection fraction (LVEF) evaluation performed within 60 days prior to enrollment. LVEF may be established with echocardiogram or MUGA scan, and left ejection fraction must be ≥ 35%. Cardiac evaluation for other participants is at the discretion of the treating physician\n* START OF TREATMENT: Participants with a history of chronic obstructive pulmonary disease (COPD), emphysema, or greater than 30 pack year smoking history should undergo pulmonary function tests (PFTs) and meet the following criteria:\n\n  * Forced expiratory volume in 1 second (FEV1) ≥ 50% of predicted and carbon monoxide diffusing capacity (DLCO) (corrected) ≥ 40% of predicted will be eligible\n\nExclusion Criteria for Leukapheresis:\n\n* LEUKAPHERESIS: Prior solid organ transplant or allogeneic hematopoietic stem cell transplant. Kidney transplant participants will be considered on a case-by-case basis requiring discussion with principal investigator (PI). If the participant has had a kidney transplant, participant must have dialysis access, dialysis plan, supportive nephrologist, willingness to stop transplant immunosuppression, and express understanding that rejection is possible outcome. Dialysis or costs related to transplant kidney will not be supported by the study. Participants having had any other solid organ transplants will be excluded, as will those with any history of allogeneic hematopoietic stem cell transplant\n\nExclusion Criteria at Start of Treatment:\n\n* START OF TREATMENT: Evidence of TET2, ASXL1 or DNMT3a mutations as sole evidence of MRD\n* START OF TREATMENT: Pregnancy, breastfeeding, or expecting to conceive or father children for the duration of the trial through 4 months after last T cell infusion. Participants of childbearing potential must have a negative serum pregnancy test within the 2 weeks (14 days) preceding T cell infusion. Childbearing potential is defined as women who have not been surgically sterilized and who are not post-menopausal (free of menses for at least 1 year)\n* START OF TREATMENT: Active autoimmune disease: Participants with active autoimmune disease requiring immunosuppressive therapy are excluded. Case-by-case exemptions are possible with approval by PI\n* START OF TREATMENT: Unable to generate FH-WT1-E50 TCR T cells for infusions. However, if a lower than planned number of cells is available, the participant will have the option to receive the generated WT1-specific T cells\n* START OF TREATMENT: Corticosteroid therapy at a systemic dose equivalent of \\> 0.5 mg\u002Fkg of prednisone-equivalent per day. The following treatments are permitted: intranasal, inhaled, topical, or local steroid applications; systemic corticosteroids at physiologic doses equivalent to no more than 10 mg\u002Fday prednisone; steroids as premedication for contrast dye allergy\n* START OF TREATMENT: Concurrent use of other investigational anti-cancer agents\n* START OF TREATMENT: Active uncontrolled infection: HIV positive participants on highly active antiretroviral therapy (HAART) with a CD4 count \\> 500 cells\u002Fmm3 are considered controlled, as are individuals with a history of hepatitis C who have successfully completed antiviral therapy with an undetectable viral load, and those with hepatitis B who have, per standard practice, hepatitis well-controlled on medication\n* START OF TREATMENT: Uncontrolled concurrent illness: Participants may not have uncontrolled or concurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* START OF TREATMENT: Known allergic reactions to any of the components of study treatments\n* START OF TREATMENT: Other medical, social, or psychiatric factors that interfere with medical appropriateness and\u002For ability to comply with study, as determined by the PI",{"count":573,"type":21},9,[77],"This phase I trial tests the safety, side effects and best dose of FH-WT1-E50 TCR T cells with azacitidine for the treatment of minimal residual disease (MRD) positive acute myeloid leukemia (AML). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize WT1, a protein on the surface of cancer cells. These WT1-specific T cells may help the body's immune system identify and kill WT1 cancer cells. Azacitidine is in a class of medications called antimetabolites. It works by stopping or slowing the growth of cancer cells. Giving FH-WT1-E50 TCR T Cells with azacitidine may be safe and\u002For effective for the treatment of MRD positive AML.",[80],{"date":497,"type":36},{"date":579,"type":21},"2026-10-01",{"date":581,"type":21},"2030-07-19",{"name":42,"class":43},""]