[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Washington\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":615},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,196,0,25,[9,43,69,92,115,139,172,193,223,245,271,292,326,345,366,388,416,436,461,482,506,528,548,569,596],{"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":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100643239","phase-1-samuraciclib-for-the-treatment-of-patients-with-resectable-borderline-resectable-or-locally-advanced-basal-pancreatic-cancer-100643239",false,"NCT07645651","Samuraciclib for the Treatment of Patients With Resectable, Borderline Resectable, or Locally Advanced Basal Pancreatic Cancer","Phase 1b Window-of-Opportunity Study Evaluating CDK7 Inhibition in Patients With Localized Basal Pancreatic Cancer","Inclusion Criteria:\n\n* Histologically or cytologically proven basal pancreatic adenocarcinoma. Histologies other than adenocarcinoma, or any mixed histologies, will NOT be eligible.\n\n  * Basal tumors are defined as GATA6- and HMGA2+. Tumor cores are considered positive for GATA6 or HMGA2 if greater than 10% of tumor epithelial cells had positive nuclei\n* Resectable, borderline resectable, or locally advanced pancreatic ductal adenocarcinoma (PDA) at diagnosis based on contrast-enhanced CT or magnetic resonance imaging (MRI) (CT or MRI without contrast as part of positron emission tomography (PET)\u002FCT or PET\u002FMRI is NOT acceptable; CT or MRI with contrast as part PET\u002FCT or PET\u002FMRI is acceptable) of the chest, abdomen, and pelvis. The institutional radiologist must review the scans. Resectable, borderline resectable, and locally advanced will be defined by National Comprehensive Cancer Network (NCCN) guidelines version 2.2025.\n\n  * There must be no evidence of metastatic disease\n* Must be 18 years or older\n* Ability to understand and willingness to sign a written informed consent document\n* Archival biopsy specimen collected within 3 months must be available. If not available, a diagnostic EUS\u002FFNB will be performed during screening\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL (within 14 days prior to study drug)\n* Platelets ≥ 100,000\u002FmcL (within 14 days prior to study drug)\n* Hemoglobin ≥ 9 g\u002FdL (within 14 days prior to study drug)\n* Creatinine clearance ≥ 50 ml\u002Fmin by Cockcroft-Gault\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both ≤ 2.5X ULN (within 14 days prior to study drug)\n* Total bilirubin ≤ 1.5X ULN (within 14 days prior to study drug)\n* Participants must not be pregnant or nursing. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test within 72 hours of treatment initiation, where WOCBP are defined as all female participants between 18 - 55 years of age. Participants of child-bearing potential must be willing to employ two highly effective and acceptable forms of contraception for up to 6 months after the final administered dose of investigational agent. A woman is considered to be of reproductive potential if she has had menses at any time in the preceding 12 consecutive months\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n\nExclusion Criteria:\n\n* Prior radiation\n* Unable to tolerate oral medication, per assessment of the principal investigator (PI)\n* Participants who are receiving other investigational agents\n* Concomitant mediation use should only exclude patients from trial participation when clinically relevant known or predicted drug-drug interactions or potential overlapping toxicities will impact safety or efficacy\n* Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Refractory nausea and vomiting, chronic gastrointestinal diseases or previous significant bowel resection with clinically significant sequelae that precluded adequate absorption of samuraciclib\n* Uncontrolled seizures\n* Active infection\n* Active bleeding diatheses\n* Known active hepatitis B or hepatitis C infection\n* Breastfeeding or pregnancy\n* Receipt of systemic corticosteroids within 14 days before the first dose of study medication\n* Receipt of St. John's Wort within 21 days before the first dose of study medication or of another concomitant medication, herbal supplement, or food that was a strong inhibitor or inducer of CYP3A4, CYP2C19, CYP2D6, or P-glycoprotein activity within 21 days before the first dose of samuraciclib\n* Known hypersensitivity to samuraciclib or any excipient of the product","ALL","18 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of this study is to evaluate the safety and efficacy of samuraciclib in patients with localized pancreatic cancer.",[27,28,29],"Resectable Pancreatic Ductal Adenocarcinoma","Borderline Resectable Pancreatic Ductal Adenocarcinoma","Locally Advanced Pancreatic Ductal Adenocarcinoma","RECRUITING","2026-08-19",{"date":33,"type":34},"2026-08-20","ACTUAL",{"date":36,"type":21},"2026-09-15",{"date":38,"type":21},"2027-11-01",{"name":40,"class":41},"University of Washington","OTHER",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":42},"100617724","phase-2-sx-682-and-atezolizumab-for-the-treatment-of-advanced-or-metastatic-recurrent-non-small-cell-lung-cancer-100617724","NCT07322341","SX-682 and Atezolizumab for the Treatment of Advanced or Metastatic, Recurrent Non-small Cell Lung Cancer","A Phase 2 Trial of SX-682 and Atezolizumab in Patients With Advanced NSCLC Who Progressed on Prior Chemotherapy and Immune Checkpoint Inhibitor (ICI) Therapy","Inclusion Criteria:\n\n* Age 18 years and older\n* Ability to understand and willingness to sign a written informed consent document\n* Pathologically or cytologically confirmed non-small cell lung cancer with no known oncogenic EGFR mutation, ALK fusion, ROS1 fusion or RET fusions.\n\n  * For participants with NSCLC harboring an oncogenic alteration other than the above must have received prior targeted therapy (e.g. small molecule inhibitor therapy or antibody drug conjugates). A wash-out of at least 5 half-lives is required prior to start of study treatment\n* Metastatic or recurrent NSCLC. Stage 3C per 8th edition TNM stage classification is allowed if not amenable to curative surgery or radiation per investigator judgment\n* Participants must have received and progressed on at least 6 weeks of treatment with prior anti-PD-1 or anti-PD-L1 therapy for advanced disease. Also, participants must have received prior platinum doublet chemotherapy. Anti-PD1\u002FPD-L1 therapy may have been received concurrently with chemotherapy or as sequential therapy (e.g. anti-PD1 followed by chemotherapy).\n\n  * For participants who received neoadjuvant, adjuvant and\u002For consolidation anti-PD-1 or anti-PD-L1 therapy for stage 1 - 3 NSCLC: If they experienced disease progression ≤ 365 days from initiation of anti-PD-1 or anti-PD-L1 therapy, this counts as the allowed anti-PD-1 or anti-PD-L1 therapy for advanced disease.\n  * For participants who experienced disease progression more than 365 days from initiation of anti-PD-1 or anti-PD-L1 therapy for advanced disease, this is not considered anti-PD-1 or anti-PD-L1 therapy for advanced disease. These patients must have received anti-PD-1 or anti-PD-L1 therapy for stage 4 or recurrent disease\n* Participants must have a minimum of 28 days after the last dose, or 5 half-lives of washout period (whichever is shorter) from last dose of most recent systemic therapy prior to initiation of study treatment, including investigational agents\n* Participants must have at least one site of measurable disease as determined by the investigator, using RECIST v 1.1 criteria documented within 28 days prior to study treatment initiation\n* Participants must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 at the time of informed consent and at the time of treatment initiation\n* Participants must be willing to provide pre-treatment archived specimen (taken within a year of trial entry) or undergo a biopsy procedure if archived specimen is not available.\n\n  * If biopsy is not deemed safe, it may be waived after discussion with principal investigator (PI)\n* Participants must be willing to provide an on-treatment biopsy, to be obtained at 6 - 9 weeks, if deemed safe by the treating physician\n* Platelet count \\> 100,000\u002FμL\n* Absolute neutrophil count \\> 1,500\u002FμL\n* Hemoglobin \\> 9.0 g\u002FdL. Participants may be transfused to meet this criterion\n* Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) \\\u003C 2.5 times upper limit of normal\n* Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) with the following exception: Patients with known Gilbert disease: serum bilirubin ≥ 3 x ULN\n* Creatinine clearance ≥ 30 mL\u002Fmin\n* For patients not receiving therapeutic anticoagulation: International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN\n* For patients receiving therapeutic anticoagulation: stable anticoagulant regimen\n* Participants of child-bearing potential and sexually active men must agree to use adequate contraception (hormonal methods must be supplemented by barrier method) prior to treatment initiation, during treatment, and for 5 months after the last dose of atezolizumab\n* Negative beta human chorionic gonadotropin (β-hCG) pregnancy test result within 14 days prior to initiation of study treatment for participants of childbearing potential. Pregnant or breast-feeding women or intention of becoming pregnant during study treatment or within 5 months of last dose of atezolizumab are not eligible\n\nExclusion Criteria:\n\n* Presence of other active cancers within the last 2 years. Participants with another cancer who have received definitive therapy at least 2 years previously and no evidence of recurrence are eligible. All participants with previously treated in situ carcinoma are eligible, as are participants with history of non-melanoma skin cancer\n* Symptomatic central nervous system (CNS) metastases; participants with known brain metastasis must be asymptomatic with no ongoing requirement for steroids within 7 days prior to start of study treatment, no history of intracranial hemorrhage or spinal cord hemorrhage. If the patient is receiving anti-convulsant therapy, the dose is considered stable\n\n  * Participants with untreated CNS metastases may be enrolled as long as they meet the above criteria. Participants with bulky CNS metastases should consider receiving radiation prior to study entry per investigator judgment\n* Participants with spinal cord compression must have received local treatment and must have been symptomatically stable with no use of steroids for at least 7 days prior to start of study treatment\n* Participants must not have an active autoimmune disease that has required immune modulating treatment within 1 year prior to consenting (i.e., disease modifying agents, long term corticosteroids). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed. Short-term steroid therapy (≤ 2 weeks) is allowed\n* Inability to discontinue corticosteroid therapy; steroids must be tapered off 7 days prior to first dose of SX-682. Limited steroid use for allergic reactions is acceptable\n* Known history of primary immunodeficiency\n* History of organ transplant or prior allogenic stem cell transplantation that requires use of immunosuppressives\n* Current symptomatic pneumonitis and any past history of immune checkpoint inhibitor related pneumonitis regardless of steroid treatment history\n* Prior history of grade 3 or higher immune checkpoint inhibitor (ICI)-induced immune-related adverse event (AE) (immune related adverse event \\[irAE\\]) except endocrine irAEs that are resolved or managed with replacement therapy\n* Radiotherapy within 7 days of start of study treatment\n* Major surgery within 21 days of start of study treatment. Minor surgery within 2 weeks of start of study treatment.\n\n  * Placement of vascular access device and biopsies are not considered major or minor surgery and are allowed\n* Electrocardiogram (ECG) demonstrating a Fridericia's corrected QT interval (QTcF) interval \\> 480 msec or patients with congenital long QT syndrome\n* Severe lung disease (e.g. chronic obstructive pulmonary disease \\[COPD\\]) who cannot stop steroids 7 days prior to start of study treatment\n* Serious cerebrovascular and cardiac disease defined as:\n\n  * Active unstable angina pectoris\n  * Congestive heart failure New York Heart Association (NYHA) \\> grade 3\n  * Acute myocardial infarction within 3 months of consenting\n  * Stroke or transient ischemic attack within 3 months of consenting\n* Known active chronic infections: Active hepatitis B, hepatitis C and tuberculosis. Testing is not required for assessment of eligibility per investigator judgment. Active infection requiring IV antibiotics within 7 days of study treatment initiation.\n\n  * Hepatitis C virus (HCV) infection: Patients with known history of HCV infection are eligible if HCV viral load is below the limit of quantification per local assay per investigator judgment.\n  * Hepatitis B virus (HBV) infection: Patients with known history of HBV infection are eligible if HBV viral load is below the limit of quantification and negative hepatitis B surface antigen (HBsAg) per local assay per investigator judgment\n* Known uncontrolled HIV (human immunodeficiency virus) infection\n\n  * Participants with known HIV infection are allowed if they are receiving anti-retroviral therapy, have CD4+ T-cell count \\> 350 cells\u002FµL within 6 months prior to study treatment initiation and no history of AIDS- defining opportunistic infection\n* Any serious or uncontrolled concomitant disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study\n* Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent\n* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab\n* History of leptomeningeal disease\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment, or 5 half-lives of washout period (whichever is shorter) from last dose of most recent systemic therapy\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* Known allergy or hypersensitivity to any component of the atezolizumab formulation",{"count":51,"type":21},32,[53],"PHASE2","This phase II trial tests how well SX-682 and atezolizumab works for the treatment of non-small cell lung cancer (NSCLC) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic), and has come back after a period of improvement (recurrent). SX-682 blocks proteins that may be able to stimulate the immune system to kill and eliminate tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving SX-682 and atezolizumab may be effective for the treatment of advanced or metastatic, recurrent NSCLC.",[56,57,58,59,60],"Advanced Lung Non-Small Cell Carcinoma","Metastatic Lung Non-Small Cell Carcinoma","Recurrent Lung Non-Small Cell Carcinoma","Stage III Lung Cancer AJCC v8","Stage IV Lung Cancer AJCC v8","NOT_YET_RECRUITING",{"date":63,"type":34},"2026-08-21",{"date":65,"type":21},"2026-09-01",{"date":67,"type":21},"2031-11-01",{"name":40,"class":41},{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100573345","phase-2-personalized-reduction-of-chemotherapy-intensity-through-ctdna-evaluation-for-the-treatment-of-patients-with-advanced-hodgkin-lymphoma-100573345","NCT06745076","Personalized Reduction of Chemotherapy Intensity Through ctDNA Evaluation for the Treatment of Patients With Advanced Hodgkin Lymphoma","A Multicenter Study PRECISE-HL: Personalized Reduction of Chemotherapy Intensity Through ctDNA Evaluation in Advanced Hodgkin Lymphoma","Inclusion Criteria:\n\n* Classical Hodgkin lymphoma without prior systemic therapy, stage 3 or 4. Corticosteroids for symptom relief are allowed\n* Measurable disease per Lugano criteria\n* Patients must be appropriate candidates for 6 cycles of combination chemotherapy including an anthracycline\n* No evidence of active central nervous system lymphoma\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Absolute neutrophil count (ANC) ≥ 500\u002Fmm\\^3. Growth factor and\u002For transfusion support is permissible to stabilize participant prior to study treatment if needed. There is no lower limit to cytopenias if related to bone marrow involvement or underlying Hodgkin lymphoma\n* Platelets ≥ 50,000\u002Fmm\\^3 (without transfusion or growth factor support). Growth factor and\u002For transfusion support is permissible to stabilize participant prior to study treatment if needed. There is no lower limit to cytopenias if related to bone marrow involvement or underlying Hodgkin lymphoma\n* Hemoglobin ≥ 8 g\u002FdL. Growth factor and\u002For transfusion support is permissible to stabilize participant prior to study treatment if needed. There is no lower limit to cytopenias if related to bone marrow involvement or underlying Hodgkin lymphoma\n* Serum creatinine \\\u003C 1.5 x upper limits of normal (ULN) or creatinine clearance greater than 30\u002Fml per minute by Cockcroft Gault formula\n* Total bilirubin ≤ 1.5 times upper limit of normal OR direct bilirubin ≤ ULN for participants with total bilirubin levels \\> 1.5 × ULN). Patients with Gilbert Syndrome and direct bilirubin \\\u003C 1.5 x ULN or confirmatory UGT1A1 testing are allowed to enroll\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal (≤ 5 × ULN for participants with liver involvement)\n* Patients must be age 18 or older\n* All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines\n* Patients must be anticipated to complete all planned study therapy\n* Male patients must agree to use an adequate method of barrier contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\n* Female patients of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Female patients of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year\n\nExclusion Criteria:\n\n* Patients known positive for HIV or infectious hepatitis type B or C with a detectable viral load may not participate. Hepatitis B\u002FC, and HIV testing are not required at screening unless mandated by local health authority.\n\n  * Patients living with HIV, on anti-viral treatment and undetectable viral load are allowed\n  * Patients with positive hepatitis (hep) B core antibody are allowed on study with an undetectable viral load and appropriate prophylaxis\n  * Patients with positive hepatitis C antibody are allowed with undetectable viral load\n* Pregnant or nursing women. Men or women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method\n* Patients with other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, breast or cervical cancer in situ, or other cancer from which the patient has been disease-free for 2 years or greater, unless approved by the principal investigator\n* Patients who have other medical conditions that would contraindicate treatment with aggressive chemotherapy (including active infection, uncontrolled hypertension, congestive heart failure, unstable angina pectoris, or myocardial infarction within the past 6 months, uncontrolled arrhythmia, severe pulmonary disease or requirement of supplemental oxygen)\n* Active ischemic heart disease (eg. myocardial infarction within 6 months) or congestive heart failure (eg. left ventricular ejection fraction \\\u003C 50%)\n* Concurrent use of other anti-cancer agents or experimental treatments\n* Known current or prior autoimmune disease with the exception of vitiligo. Patients with a history of autoimmune thyroid disease on a stable dose of thyroid hormone are also allowed\n* Active or prior history of pneumonitis\u002Finterstitial lung disease that required corticosteroids\n* Current use of supplemental oxygen\n* Is known to have received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of trial treatment. Other non-live or live-attenuated vaccines (eg. COVID, Influenza) are allowed",{"count":77,"type":21},125,[53],"This phase II trial tests how well personalized reduction of chemotherapy (nivolumab, doxorubicin, vinblastine and dacarbazine) based on circulating tumor deoxyribonucleic acid (ctDNA) evaluation works for treating patients with Hodgkin lymphoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Chemotherapy drugs, such as nivolumab, doxorubicin, vinblastine and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Many types of tumors tend to lose cells or release different types of cellular products including their DNA, which is referred to as ctDNA, into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids and, based on the result, assign patients to a reduced number of chemotherapy treatments or the standard number of chemotherapy treatments. Using ctDNA to assign a personalized reduction of chemotherapy may be effective in treating patients with advanced Hodgkin lymphoma.",[81,82,83,84],"Advanced Hodgkin Lymphoma","Classic Hodgkin Lymphoma","Lugano Classification Stage III Hodgkin Lymphoma AJCC v8","Lugano Classification Stage IV Hodgkin Lymphoma AJCC v8",{"date":33,"type":34},{"date":87,"type":34},"2025-03-06",{"date":89,"type":21},"2033-01-03",{"name":40,"class":41},6,{"id":93,"slug":94,"hasResults":12,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":109,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":42},"100519224","a-home-based-prehabilitation-exercise-intervention-for-improving-physical-function-in-patients-with-bladder-cancer-and-upper-tract-urothelial-cancer-get-moving-trial-100519224","NCT06040762","A Home-Based Prehabilitation Exercise Intervention for Improving Physical Function in Patients With Bladder Cancer and Upper Tract Urothelial Cancer, Get Moving Trial","The \"Get Moving Trial\": A Phase I\u002FII RCT of Home-Based (P)Rehabilitation With ExerciseRx in Bladder Cancer and Upper Tract Urothelial Cancer","Inclusion Criteria:\n\n* 18 years of age or older\n* English-speaking\n* Planned treatment with radical cystectomy or radical nephroureterectomy\u002Fureterectomy with or without preceding systemic therapy as indicated by the patient's surgeon with enough time to complete a minimum of 4 weeks of exercises before surgery if enrolled in the (P)REHAB arm\n* Willing and able to participate in trial activities\n\nExclusion Criteria:\n\n* Cognitive\u002Fmental impairment that will preclude ability to participate in routine exercise activities. Significant cognitive or memory impairment or baseline dementia that would preclude a patient's ability to follow instructions or reproduce exercises\n* Immobility, inability\u002Funwillingness to perform personalized exercise program. Inability to perform exercises safely from seated or standing position at home or recent falls or high fall risk. Neurologic or orthopedic condition(s) that restricts participation in unsupervised home exercises, such as prior stroke with neurologic impairment, weight-bearing precautions, or unwillingness to participate in exercises\n* Participants who have nonmuscle-invasive urothelial cancer of the bladder\u002Fupper tract anticipating undergoing organ-preserving treatments, or radiographic evidence of metastatic disease involving other organs including brain metastases.\n* Patients with predominant histology other than urothelial carcinoma of the bladder or upper tracts (e.g. metastasis from another cancer) who would not otherwise be considered candidates for standard definitive or consolidative surgeries (radical cystectomy, ureterectomy, radical nephroureterectomy) with\u002Fwithout treatment with preoperative\u002Fneoadjuvant systemic therapy.\n* Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant women are excluded from this study\n* Inability to understand or read English\n* Lack of access or lack of sufficient facility to use an Android or iOS smart device with the minimum criteria for using ExerciseRx\n* Not receiving surgery at UWMC\n* Participation in a clinical trial that does not permit enrollment in the Get Moving trial",{"count":100,"type":21},128,[102],"NA","Prehabilitation refers to the process of improving a patient's functional capabilities prior to a surgical procedure with the goal of decreasing post-surgical inactivity and physical decline. This clinical trial evaluates the utility of a personalized home-based prehabilitation exercise intervention for the improvement of physical function and surgical outcomes in patients with urothelial carcinoma undergoing definitive or consolidative surgery of the bladder (radical cystectomy) or upper tract (nephroureterectomy, ureterectomy) with or without preceding neoadjuvant\u002Fsystemic therapy. The exercise intervention includes at-home exercise sessions focused on the improvement of core strength and balance as well as personalized step count goals, delivered to patients remotely via a smart-device-based application (ExerciseRx). Encouraging physical activity before surgery may improve physical function and surgical outcomes in patients who are scheduled to undergo surgery for their bladder or urothelial cancer.",[105,106,107,108],"Bladder Cancer","Urothelial Carcinoma","Upper Tract Urothelial Carcinoma","Renal Pelvis and Ureter Urothelial Carcinoma",{"date":33,"type":34},{"date":111,"type":34},"2023-12-19",{"date":113,"type":21},"2027-04-30",{"name":40,"class":41},{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":12,"sex":122,"minAge":18,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":42},"100652406","uterine-lavage-to-detect-ovarian-cancer-risk-100652406","NCT07772869","Uterine Lavage to Detect Ovarian Cancer Risk","Collection of Uterine Lavage in High-Risk Patients as a Potential Biomarker for Ovarian Cancer Risk","Inclusion Criteria:\n\n* \\> 18 years of age\n* Have a pathogenic BRCA1 or BRCA2 germline variant\n* Planned risk-reduction surgery\n* Presence of uterus and at least one fallopian tube\n\nExclusion Criteria:\n\n* Prior tubal ligation\n* Prior history of known ovarian or endometrial cancer","FEMALE",{"count":124,"type":21},75,[102],"This clinical trial develops a non-surgical approach using uterine lavage samples to screen for progression to ovarian cancer in high-risk patients carrying BRCA mutations. Women with inherited mutations in the BRCA1 and BRCA2 genes (BRCA carriers) have a much higher lifetime risk of developing ovarian cancer. Currently there are no effective ovarian cancer screening or early detection tests for BRCA carriers. Uterine lavage is a procedure that uses saline to rinse and collect cells from the fallopian tube. Molecular analysis of these samples may help proactively detect genetic alterations that are indicative of progression to ovarian cancer in women with BRCA mutations.",[128,129,130,131],"BRCA Hereditary Ovarian Carcinoma","Fallopian Tube High Grade Serous Adenocarcinoma","Ovarian High Grade Serous Adenocarcinoma","Primary Peritoneal High Grade Serous Adenocarcinoma","2026-08-18",{"date":33,"type":34},{"date":135,"type":21},"2026-08",{"date":137,"type":21},"2028-06-01",{"name":40,"class":41},{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":122,"minAge":4,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":151,"conditions":152,"keywords":158,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":42},"100625608","phase-2-xylitol-and-the-prevention-of-periodontal-disease-and-preterm-birth-trial-100625608","NCT07424846","Xylitol and the Prevention of Periodontal Disease and Preterm Birth Trial","Xylitol and the Prevention of Periodontal Disease and Preterm Birth (XaPPP) Trial","XaPPP","Inclusion Criteria:\n\n* Able to provide informed consent. For those under 18 years of age, an approval will additionally be sought from the parent or guardian\n* Less than 20 weeks' gestation (by best obstetric estimate)\n* At least 20 natural teeth\n* Planning to deliver at one of the health facilities within the XaPPP trial\n* Receiving antenatal obstetric care at one of the 8 health districts\n* Willing to chew two pieces of gum thrice daily for 5 minutes after the morning, day and evening meals throughout pregnancy\n* Willing to attend all study visits\n* Willing to provide biospecimens (oral, vaginal, placental, breast milk)\n* Willing to undergo at least two dental exams including oral microbiota sampling at study enrolment \\\u003C20 weeks of pregnancy, 28-30 weeks of pregnancy, and 6-8 weeks after giving birth\n* Willing to have their child undergo follow up through at least 12 months after birth including neurodevelopmental examination(s)\n* Speaks Chichewa or English\n\nAll patients who meet inclusion criteria will be approached without regard to sex, race, ethnicity, parents' country of origin, or religious preferences.\n\nExclusion Criteria:\n\n* Those who upon screening and enrolment but dislike the taste of the gum and state they will not chew the gum throughout pregnancy\n* Gravidae with known or suspected non-viable pregnancy (including life threatening congenital anomalies such as cardiac, neurological or others)\n* Pregnant individual has a life-threatening diagnosis such as cancer requiring treatment during pregnancy\n* Pregnant women with a known or suspected morbidly adherent placenta (such as placenta accrete, increta and percreta)\n* Known allergy to xylitol",{"count":148,"type":21},6000,[53,150],"PHASE3","The ground-breaking Prevention of Prematurity and Xylitol (PPaX) cluster randomized controlled clinical trial was conducted in Lilongwe, Malawi and enrolled approximately 10,069 pregnant individuals seeking to evaluate the impact of xylitol-containing chewing gum compared to no chewing gum on reducing the occurrence of maternal periodontal disease, preterm birth, and low birthweight offspring. The premise of this study centers upon the numerous publications supporting a strong association between maternal periodontal disease and preterm birth. Given that xylitol-containing chewing gum is considered a prebiotic and known to reduce cariogenic and periodontopathic bacteria, the study evaluated and discovered a statistically significant reduction in maternal periodontal disease, preterm birth, and low birthweight offspring among pregnant individuals who chewed xylitol-containing chewing gum.\n\nWhile PPaX demonstrated the efficacy of xylitol to reduce preterm birth (PTB), the study had important limitations: (a) PPaX was an unblinded cluster-randomized study with only 8 clusters, 4 with xylitol-containing chewing gum and 4 without any gum (not placebo-controlled); (b) PPaX used a suboptimal dose of 2 grams of xylitol daily which may have reduced the effectiveness of the intervention given that recent literature suggests 5-10 grams\u002Fday more effectively improve oral health; and (c) PPaX did not evaluate infant mortality nor early neurodevelopmental outcomes. Notably, reducing fetal exposure to periodontal disease (PD) as well as PTB may improve neurodevelopmental outcomes for offspring as both prematurity and fetal exposure to inflammation are well-documented risk factors for neurodevelopmental delay (NDD) and infant mortality.\n\nThe investigators will conduct a double-blind, placebo-controlled, individually randomized clinical trial with 3 arms among Malawian pregnant individuals (n=6000) at \\\u003C20 weeks of pregnancy with the co-primary outcomes being the incidence of PTB and low birthweight offspring. The 3 study arms (n=2000 each) will be (a) an optimized dose of xylitol-containing chewing gum (6.4 grams\u002Fday), (b) the PPaX trial xylitol dose (2.1 grams\u002Fday), or (c) flavored sorbitol gum base (placebo control). This trial overcomes the PPaX trial's limitations and will definitively answer whether xylitol prevents PTB in Malawi. The investigators will additionally collect biospecimens from a random sampling of the participants for biobanking for later analysis of inflammatory and microbiome alterations that may occur with xylitol exposure compared with placebo. The investigators hypothesize that pregnant individuals who chew xylitol-containing chewing gum will have a significant reduction in periodontal disease metrics at 28-30 weeks' gestation (e.g. bleeding on probing) as well as offspring with improved neurodevelopmental outcomes as assessed by the Bayley Scales of Infant and Toddler Development 4th edition and reduced risk of adverse pregnancy outcomes including preterm birth.",[153,154,155,156,157],"Preterm Birth","Low Birthweight Neonate","Periodontitis","Gingivitis","Developmental Delay",[159,160,161,162,163,164,165],"xylitol","preterm birth","prematurity","pregnancy","periodontitis","periodontal disease","chewing gum",{"date":33,"type":34},{"date":168,"type":34},"2026-03-26",{"date":170,"type":21},"2030-09-30",{"name":40,"class":41},{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":22,"phases":181,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":42},"100604394","phase-2-pacritinib-with-standard-of-care-azacitidine-or-decitabine-as-a-bridge-to-allogeneic-hematopoietic-stem-cell-transplant-for-patients-with-accelerated-and-blast-phase-myeloproliferative-neoplasms-100604394","NCT07148947","Pacritinib With Standard of Care Azacitidine or Decitabine as a Bridge to Allogeneic Hematopoietic Stem Cell Transplant for Patients With Accelerated and Blast Phase Myeloproliferative Neoplasms","A Phase 2 Trial Investigating the Addition of Pacritinib to a Hypomethylating Agent as a Bridge to Allogeneic Hematopoietic Stem Cell Transplant in Patients With Accelerated and Blast Phase Myeloproliferative Neoplasms","Inclusion Criteria:\n\n* Age ≥ 18 years\n* History of myeloproliferative neoplasms (MPN) as defined by the 2016 and 2022 World Health Organization criteria, with now pathologically confirmed ≥ 5% blasts in the bone marrow or peripheral blood. Prior MPNs could include polycythemia vera, essential thrombocythemia, primary myelofibrosis, secondary myelofibrosis, MPN-unclassifiable, and myelodysplastic syndrome (MDS)\u002FMPN overlap syndromes\n* Outside diagnostic material is acceptable. Internal review at the study institution of outside peripheral blood and\u002For bone marrow slides is recommended. Flow cytometric analysis of peripheral blood and\u002For bone marrow should be performed according to institutional practice guidelines\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 OR Karnofsky ≥ 60%\n* Serum creatinine clearance ≥ 50 ml\u002Fmin calculated by the Cockcroft-Gault Equation (assessed within 14 days of study day 1)\n* Total bilirubin ≤ 3 (total bilirubin \\> 3 is allowable if thought due to Gilbert's disease, hemolysis, or MPN disease) (assessed within 14 days of study day 1)\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) \\\u003C 3 x upper limits of normal (ULN) (total bilirubin \\> 3 is allowable if thought due to Gilbert's disease, hemolysis, or MPN disease) (assessed within 14 days of study day 1)\n* Patient is considered a potential transplant candidate. The attending\u002Ftreating physician will determine transplant candidacy at the time of consent\n* Intention to initiate therapy with an HMA per treating physician's standard institutional practice. Allowable HMAs include:\n\n  * Azacitidine given IV or SC\n  * Decitabine given IV, and\n  * Decitabine given orally (as Inqovi \\[cedazuridine\u002Fdecitabine\\]). If the HMA was already initiated, patients must be registered and start pacritinib within 30 days of initiation\n* Hyperleukocytosis, white blood cell (WBC) \\> 100,000\u002FμL, or with concern for other complications of high tumor burden or leukostasis (e.g. hypoxia, disseminated intravascular coagulation) can be treated with leukapheresis or may receive up to 2 doses of cytarabine (up to 500 mg\u002Fm\\^2\u002Fdose) any time prior to enrollment\n* Women of child-bearing potential and men must be agree to use a highly effective method of contraception, starting at the first dose of study therapy through 90 days after the last dose of study therapy\n* Capable of providing valid informed consent\n\nExclusion Criteria:\n\n* Previous treatment with chemotherapy (e.g. hypomethylating agents or cytarabine-based regimens) for MPN (does not include the first cycle of treatment with an allowable HMA initiated within 30 days prior to start of pacritinib). Prior temporary measures to control blood counts is allowed. Prior treatment with hydroxyurea, interferons or JAK inhibitor therapy (including pacritinib) is allowed\n* Active systemic fungal, bacterial, viral, or other infection, unless disease is under treatment with anti-microbials and\u002For controlled or stable (e.g. if specific, effective therapy is not available\u002Ffeasible or desired \\[e.g. chronic viral hepatitis, HIV\\])\n* Known hypersensitivity to any study drug\n* Females who are pregnant or breastfeeding (Women of childbearing potential \\[WOCBP\\] must have a negative serum pregnancy test within 14 days prior to enrollment)\n* Treatment with any other anti-MDS\u002Fleukemia investigational agent within 2 weeks of start of study drugs\n* Corrected QT interval (QTC) \\> 480 msec as measured by the Fridericia formula (changing of medications\u002Fsupplementing electrolytes is allowed to determine if this helps QTc reduce to \\\u003C 480 msec)\n* Concurrent use of a strong CYP3A4 inhibitor or inducer at enrollment that cannot be discontinued (washout period ≥ 5 half-lives prior to day 1)",{"count":180,"type":21},27,[53],"This phase II trial tests if adding pacritinib to standard of care azacitidine or decitabine increases the number of patients able to proceed to hematopoietic stem cell transplantation (bridging) for patients with accelerated and blast phase myeloproliferative neoplasms. Pacritinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Azacitidine and decitabine are in a class of medications called hypomethylation agents. They work by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Adding pacritinib to standard of care azacitidine or decitabine may increase the number of patients able to proceed to hematopoietic stem cell transplantation for patients with accelerated and blast phase myeloproliferative neoplasms.",[184,185],"Accelerated Phase Myeloproliferative Neoplasm","Blast Phase Myeloproliferative Neoplasm","2026-08-17",{"date":31,"type":34},{"date":189,"type":34},"2026-03-02",{"date":191,"type":21},"2028-12-31",{"name":40,"class":41},{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":201,"sex":17,"minAge":202,"maxAge":203,"enrollmentInfo":204,"targetDuration":4,"studyType":22,"phases":206,"briefSummary":207,"conditions":208,"keywords":211,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":216,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":222},"100580855","a-trial-testing-a-two-way-sms-platform-to-recognize-and-prevent-wasting-among-hiv-infected-and-hiv-exposed-uninfected-children-in-kenya-100580855","NCT06842732","A Trial Testing a Two-way SMS Platform to Recognize and Prevent Wasting Among HIV-infected and HIV-exposed Uninfected Children in Kenya","A Mixed Methods Randomized Controlled Trial Testing a Two-way SMS Platform to Recognize and Prevent Wasting Among HIV-infected and HIV-exposed Uninfected Children in Kenya","MAMMS IYCF R33","Inclusion Criteria (HIV-exposed caregiver-child pairs):\n\n* Children aged 6 to 24 months all-inclusive with a MUAC ≥ 12.5cm at the date of recruitment\n* Children living with HIV or HIV-exposed uninfected children seen as outpatients in early infant detection (EID) or HIV-care clinics at the participating hospitals\n* The child's caregiver is willing and able to provide informed consent\n* The child's caregiver can read or write or has someone to help them read or write\n* The child's caregiver is planning to remain in the catchment area with their child for \\> 6 months and willing to return to the health facility for 6-month follow up visits\n* The child's caregiver has access to a Safaricom phone line and provides a mobile phone number\n\nInclusion Criteria (healthcare workers):\n\n\\- Healthcare workers working in Homa Bay and Migori County Referral Hospitals, who have contact with pediatric inpatients\n\nExclusion Criteria:\n\n* Children with moderate or severe wasting (MUAC \\\u003C12.5cm, weight-for-height z-score \\\u003C-2, or nutritional edema) at the time of eligibility screening\n* Children with a congenital condition that limit feeding or syndromes that prevents age-appropriate feeding\n* Child is enrolled in another study that the PI judges to compromise the aims of this study\n* Child's caregiver does not pass the second training after being unable to satisfactorily complete the first MUAC training.\n* Child's caregiver is under the age of 18 years.",true,"6 Months","24 Months",{"count":205,"type":21},776,[102],"The goal of this study is to test if a two-way text-message (SMS) maternally administered malnutrition monitoring system (MAMMS) that delivers infant and young child feeding (IYCF) education and supports caregivers in monitoring their child's nutritional status at home can improve nutritional outcomes for HIV-exposed children.\n\nThe aims include 1) to determine whether the MAMMS IYCF intervention lowers the incidence of malnutrition, leads to a shorter time to recover for those that become malnourished and results in a lower incidence of hospitalizations, severe malnutrition and death, 2) to determine the cost and cost-effectiveness of the MAMMS IYCF intervention, and 3) to determine the effect of the MAMMS IYCF intervention on the behavior and attitudes of participants through change in age-appropriate feeding, IYCF knowledge, trust in the healthcare system, and intention to seek care if the child becomes wasted.\n\nThe study team will enroll 776 caregiver-child pairs aged between 6 and 24 months in Migori and Homa Bay County, Kenya. Each caregiver-child pair will be randomly assigned to either the MAMMS IYCF intervention or standard of care (SOC) and followed for 180 days (about 6 months).\n\nCaregivers assigned to the intervention arm will be asked to respond to weekly messages with the color of the MUAC tape after measuring their child's arm after being trained on how to use the MUAC measuring tape. Weekly messages will include IYCF education and other age-appropriate child health related information. Caregivers in the SOC arm will receive clinic appointment and study visit reminders only. Caregivers in the intervention arm and the SOC arm will be asked to attend the study clinic for follow-up visits at Day 90 and Day 180. At enrollment and follow-up visits, the study team will administer a survey including a child's medical history, a standardized child clinical examination, and anthropometry.",[209,210],"Malnutrition in Children","Children Exposed to HIV",[212,213,214,215],"maternally administered malnutrition monitoring system (MAMMS)","infant and young child feeding practices","wasting","two-way SMS system",{"date":31,"type":34},{"date":218,"type":34},"2025-06-05",{"date":220,"type":21},"2027-07-15",{"name":40,"class":41},2,{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":232,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":239,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":42},"100570682","evaluating-the-effects-of-hemoglobin-threshold-specific-packed-red-blood-cell-transfusions-on-quality-of-life-and-functional-outcomes-in-patients-with-high-grade-myeloid-neoplasms-acute-myeloid-leukemia-or-b-acute-lymphoblastic-lymphomaleukemia-100570682","NCT06710418","Evaluating the Effects of Hemoglobin Threshold-specific Packed Red Blood Cell Transfusions on Quality of Life and Functional Outcomes in Patients With High-grade Myeloid Neoplasms, Acute Myeloid Leukemia, or B Acute Lymphoblastic Lymphoma\u002FLeukemia","Red Blood Cell Transfusion Threshold-Specific Bleeding, Quality of Life and Functional Outcomes in Acute Leukemia Patients With Thrombocytopenia: a Randomized Feasibility Study","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of \"high-grade\" myeloid neoplasm (≥ 10% blasts in blood or bone marrow) or acute myeloid leukemia (AML) (other than acute promyelocytic leukemia \\[APL\\]) or B-cell acute lymphoblastic lymphoma\u002Fleukemia (ALL) according to the 2022 WHO classification. Outside diagnostic material is acceptable to establish diagnosis\n* Plan to undergo intensive chemotherapy induction or post-remission therapy for their diagnosis (defined as \"7+3,\" hyper-cyclophosphamide, vincristine, doxorubicin, and dexamethasone \\[CVAD\\], or regimen with cytarabine backbone ≥ 1,000mg\u002Fm\\^2), or allogeneic HSCT, expected to induce anemia requiring PRBC transfusion AND platelet counts of ≤ 30,000\u002FuL for ≥ 5 days following the therapy (as determined by principal investigator)\n* Plan to get all post-chemotherapy\u002Fpost-HSCT care at the University of Washington (UW)\u002FFred Hutchinson Cancer Center (FHCC)\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients requiring a prophylactic platelet transfusion at thresholds \\> 10,000\u002FuL\n* Patients requiring systemic anticoagulation, anti-platelet agent, or antifibrinolytic therapy that will not be held once platelets reach a level of \\\u003C 50,000\u002FuL\n* Patients with grade ≥ 2 bleeding (as determined by the WHO Bleeding Criteria) at the time of randomization\n* Arterial or venous thrombotic event, including myocardial infarction within 6 months prior to initiation of the chemotherapy\u002FHSCT\n* Patients requiring renal replacement therapy at the time of randomization\n* Patients who decline transfusion for personal or religious beliefs\n* Pregnancy or lactation",{"count":231,"type":21},50,[102],"This clinical trial evaluates the effects of hemoglobin threshold-specific packed red blood cell (PRBC) transfusions on quality of life and functional outcomes in patients who have undergone chemotherapy or an allogeneic hematopoietic stem cell transplant for a high-grade myeloid neoplasm, acute myeloid leukemia, or B acute lymphoblastic lymphoma\u002Fleukemia. Some types of chemotherapy and stem cell transplants can induce low platelet counts and\u002For anemia that requires PRBC transfusions. Given critical shortages in blood supply, and risks associated with transfusion of PRBC, there has been much investigation into the \"minimum\" hemoglobin level that effectively balances safety and toxicity in patients. This clinical trial evaluates the effects of giving PRBC transfusions based on a more restrictive hemoglobin threshold (\\> 7 gm\u002FdL) compared to a more liberal hemoglobin threshold (\\> 9 gm\u002FdL) on quality of life and functional outcomes. A more restrictive threshold may be just as effective at maintaining patient quality of life and function while decreasing side effects from blood transfusions and helping to conserve blood supply resources.",[235,236,237,238],"Acute Myeloid Leukemia","B Acute Lymphoblastic Leukemia","B Lymphoblastic Lymphoma","Myeloid Neoplasm",{"date":31,"type":34},{"date":241,"type":34},"2025-10-15",{"date":243,"type":21},"2027-12-31",{"name":40,"class":41},{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":12,"sex":17,"minAge":251,"maxAge":252,"enrollmentInfo":253,"targetDuration":4,"studyType":22,"phases":255,"briefSummary":256,"conditions":257,"keywords":260,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":42},"100467005","prevention-of-developmental-delay-and-xylitol-pddax-study-100467005","NCT05361122","Prevention of Developmental Delay and Xylitol (PDDaX) Study","Inclusion Criteria:\n\n* Child born during the PPaX trial\n* Enrollment age between 4-8 years old\n* Parental or legal guardian consent obtained\n* Willing to undergo 3 neurodevelopmental tests\n* Willing to travel to BCMF for neurodevelopmental assessment\n* Assent by the pediatric subject for participation in the study\n\nExclusion Criteria:\n\n* Parent or legal guardian cognitively unable to provide consent\n* Child unwilling to provide assent to participate in the study","4 Years","8 Years",{"count":254,"type":21},1000,[102],"The goals of this study are to: evaluate and validate the low-cost, transportable, easily-administered Malawi Developmental Assessment Tool (MDAT) for neurodevelopmental assessment of children aged 4-8 years old in Malawi, as compared to the gold-standard yet more cumbersome and costly Kaufman Assessment Battery for Children-II (KABC-II) among (1) n=500 formerly preterm children and (2) n=500 formerly term children.\n\nAdditionally, we will evaluate the effects of gestational xylitol exposure compared to a lack of gestational xylitol exposure on neurodevelopmental outcomes of children aged 4-8 years old in Malawi through the following four neurodevelopmental tests: (3) KABC-II (cognitive outcomes), (4) EF Touch (executive functions), (5) Strengths and Difficulties Questionnaire (social-emotional outcomes), and (6) MDAT (motor and cognitive outcomes).\n\nThe researchers will leverage subjects who completed the parent Prevention of Prematurity and Xylitol Trial, which enrolled 10069 pregnant individuals in Malawi and demonstrated a significant 24% reduction in incidence of preterm birth and low birthweight offspring in gravidae who chewed xylitol-containing chewing gum compared to those who did not. By ensuring that these offspring did not have higher rates of neurodevelopmental impairment, the study will promote promising multi-center international and domestic trial evaluating the impact of xylitol-containing chewing gum use and optimal dosage during pregnancy.",[258,259],"Prematurity","Neurodevelopmental Disorders",[261,262,263,258],"Xylitol","Oral Health","Pregnancy","2026-08-15",{"date":31,"type":34},{"date":267,"type":34},"2023-04-04",{"date":269,"type":21},"2027-09-30",{"name":40,"class":41},{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":12,"sex":17,"minAge":277,"maxAge":278,"enrollmentInfo":279,"targetDuration":4,"studyType":22,"phases":281,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":42},"100459848","closed-loop-spinal-stimulation-for-restoration-of-upper-extremity-function-after-spinal-cord-injury-100459848","NCT05267951","Closed-loop Spinal Stimulation for Restoration of Upper Extremity Function After Spinal Cord Injury","Inclusion Criteria:\n\n1. has cervical (C8 or higher), incomplete (American Spinal Cord Injury Impairment Scale - C or D) traumatic spinal cord injury, minimum 1-year post-injury\n2. has difficulty with hand functions in activities of daily living (e.g., dressing, grooming, feeding)\n3. stable medical condition without cardiopulmonary disease or autonomic dysreflexia that would contraindicate participation in upper extremity rehabilitation or testing activities\n4. capable of performing simple cued motor tasks\n5. has ability to attend intervention\u002Ffunctional task training and assessment sessions 3 times\u002Fweek\n6. has adequate social support to participate in all intervention and baseline\u002Ffollow-up assessment sessions throughout 40 weeks.\n7. has ability to read and speak English\n\nExclusion Criteria:\n\n1. dependent on ventilation support\n2. has implanted stimulator (e.g., pacemaker, vagus nerve stimulator, cochlear implant, etc.) or baclofen pump\n3. has metallic devices and implants in the head (e.g., deep brain stimulators, aneurysm clips\u002Fcoils, and stents, vagus nerve stimulators)\n4. has a history or current signs\u002Fsymptoms of syringomyelia (progressive pain, muscle weakness, and\u002For sensory loss; deterioration of bowel\u002Fbladder function)\n5. has autoimmune etiology of spinal cord dysfunction\u002Finjury\n6. has received botulinum toxin injections in upper extremity muscles in the prior 6 months\n7. has tendon transfer or nerve transfer surgery in the upper extremity,\n8. taking tizanidine, dantrolene or diazepam\n9. has history of seizures or increased risk for seizures\n10. has history of chronic headaches or migraines\n11. has history of neurologic diseases, such as stroke, multiple sclerosis, traumatic brain injury, etc.\n12. has peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)\n13. has rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)\n14. has significant medical disease; including uncontrolled systemic hypertension with values above 170\u002F100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation\n15. has cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention\n16. unhealed fracture, contracture, pressure sore, or frequent urinary tract infections or other illnesses that might interfere with upper extremity rehabilitation or testing activities\n17. has a history of severe allergy (i.e., allergic reaction that could not be treated with antihistaminic medication\n18. has alcohol and\u002For drug abuse (subject's verbal statement)\n19. has cancer\n20. pregnant (Childbearing potential will be asked at screening, baseline, and every subsequent visit in which the subject would receive transcutaneous spinal cord stimulation and\u002For Transcranial Magnetic Stimulation whether the participant could be pregnant. Pregnancy will be ruled out by an over-the-counter urine pregnancy test for all females of childbearing potential (1) at the time of enrollment, (2) prior to all sessions that include Transcranial Magnetic Stimulation, and also prior to the intervention phases of (3) closed-loop or (4) open-loop stimulation. Additional pregnancy tests may be performed if there is a concern of pregnancy.)\n21. lack of ability to fully comprehend, cooperate and\u002For safely perform study procedures in the investigator's opinion\u002Fjudgment\n22. unable to read and\u002For comprehend the consent form","21 Years","70 Years",{"count":280,"type":21},9,[102],"The purpose of this study is to assess the efficacy of non-invasive (transcutaneous) closed-loop electrical spinal cord stimulation for recovery of upper limb function (Aim 1) and spasticity (Aim 2) following spinal cord injury.",[284],"Spinal Cord Injuries","2026-08-14",{"date":132,"type":34},{"date":288,"type":34},"2022-10-12",{"date":290,"type":21},"2028-06-30",{"name":40,"class":41},{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":296,"acronym":297,"eligibilityCriteria":298,"healthyVolunteers":201,"sex":17,"minAge":299,"maxAge":300,"enrollmentInfo":301,"targetDuration":4,"studyType":22,"phases":303,"briefSummary":304,"conditions":305,"keywords":310,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":91},"100584790","phase-3-limited-versus-extended-trophic-feeding-let-feed-trial-100584790","NCT06893939","Limited Versus Extended Trophic Feeding (LET-FEED) Trial","LET-FEED","Inclusion Criteria:\n\n* \\\u003C1500 gram birthweight\n* 25w0d-31w6d at birth\n* Consent to feed donor milk when parent's own milk is not available or of insufficient quantity\n\nExclusion Criteria:\n\n* \\\u003C5th percentile for weight at birth (Fenton growth curve)\n* Parent or legal guardian unable to provide consent within 36 hours after birth\n* Congenital anomaly affecting decisions on enteral feedings (e.g. gastroschisis, omphalocele, congenital diaphragmatic hernia, congenital heart disease, etc.)\n* Known genetic condition affecting growth, feeding, or mortality\n* Vasopressor use within first 24 hours after birth (not including hydrocortisone)\n* Considered terminally ill","0 Years","2 Years",{"count":302,"type":21},350,[53,150],"Study Hypothesis\u002FQuestion In infants born very preterm, advancing enteral feeds after 24 hours from birth (limited trophic feeds) versus after 72 hours (extended trophic feeds) reduces the risk of all-cause late onset sepsis (LOS) without increasing the risk of other adverse outcomes.\n\nStudy Design Type This is a multi-center, open-label, parallel-group, individual randomized controlled trial comparing two different trophic feeding regimens in preterm infants born between 25w0d and 31w6d. These infants will be randomly assigned to either the intervention group, receiving limited trophic feeding (20 to 25 mL\u002Fkg\u002Fday for one day) or the control group, receiving extended trophic feeding (20 to 25 mL\u002Fkg\u002Fday for three days) prior to advancing enteral feeds until full feeding volume (140 mL\u002Fkg\u002Fday) is achieved.\n\nEligibility Criteria Preterm infants with gestational ages between 25 0\u002F7 and 31 6\u002F7 weeks and a birthweight of \\\u003C1500 grams who are admitted to six participating neonatal units will be eligible for inclusion. Infants with \\\u003C5th percentile for weight at birth, vasopressor use within first 24 hours of life major congenital\u002Fgenetic anomalies affecting enteral feeding, growth, or mortality, and those with a terminal illness in which decisions to withhold or limit support have been made will be excluded. Infants of parents or legal guardians who are unable to provide consent within 36 hours of birth will also be excluded.\n\nStudy Intervention\u002FMethods Written parental informed consent will be obtained prenatally or within the first 36 hours of birth. Infants will be randomized to receive limited trophic feeds of 24 to 36 hours or extended trophic feeds for 72 hours prior to the advancement of enteral feeds. Infants will be fed parent's own milk (POM) with donor human milk as the alternative if POM is unavailable.\n\nPrimary Outcome Late-onset sepsis, defined as positive blood, urine, and\u002For cerebrospinal fluid (CSF) cultures in the presence of compatible clinical signs of sepsis, occurring after postnatal day 3 and before hospital discharge, and treated with antibiotics for 5 days or more.\n\nSecondary Outcome(s) The trial will assess various secondary outcomes including length of hospital stay, all-cause in-hospital mortality, duration of IV fluids and central line utilization, necrotizing enterocolitis (Bell's stage IIa or higher), severe intraventricular hemorrhage (grade III or IV either unilaterally or bilaterally), bronchopulmonary dysplasia (oxygen requirement or positive pressure ventilation at 36 weeks corrected gestational age), or retinopathy of prematurity requiring intervention. Additionally, growth metrics throughout hospitalization will be evaluated using change in weight, length, and head circumference z-scores from birth to 36 weeks' corrected gestational age between infants in the limited and extended trophic feeding groups.\n\nWe will also evaluate the 2 year developmental outcomes of a subset of participants who consent to follow up. This will include the Bayley Scales of Infant and Toddler Development-4th edition Language, Cognitive, and Motor domain scores at 2 years corrected age.",[306,307,308,309],"Sepsis","Length of Stay","Mortality","Neurodevelopmental Delay",[311,312,258,313,314,315,316,317,318],"Feeding","Nutrition","Very preterm","Trophic","Trophic feeds","Trophic feeding","enteral feeds","sepsis","2026-08-13",{"date":186,"type":34},{"date":322,"type":34},"2025-07-03",{"date":324,"type":21},"2031-02-28",{"name":40,"class":41},{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":22,"phases":335,"briefSummary":336,"conditions":337,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":344,"locationsCount":42},"100644764","phase-2-18fftt-positron-emission-tomographycomputed-tomography-to-predict-treatment-response-in-patients-scheduled-to-receive-gemcitabine-cisplatin-and-durvalumab-for-newly-diagnosed-cholangiocarcinoma-100644764","NCT07673341","[18F]FTT Positron Emission Tomography\u002FComputed Tomography to Predict Treatment Response in Patients Scheduled to Receive Gemcitabine, Cisplatin, and Durvalumab for Newly Diagnosed Cholangiocarcinoma","Imaging PARP Expression in Cholangiocarcinoma","Inclusion Criteria:\n\n* Patient must have histologically confirmed cholangiocarcinoma\n* Patient must be newly diagnosed and have not yet been treated\n* Patient planned to receive GCD per standard-of-care\n* Patient must have evaluable disease or at least one measurable lesion that can be assessed at baseline by CT (or MRI) per RECIST 1.1\n* Age ≥ 18 years\n* For women of childbearing potential, a negative serum pregnancy test is required within 7 days prior to \\[18F\\]FTT PET imaging\n* Men and women of reproductive potential need to agree to employ acceptable forms of contraception throughout their participation in the study that meet requirements for GCD treatment per standard of care\n* Patient is willing and able to comply with the protocol for the duration of the study including undergoing all study procedures\n* Ability to understand and the willingness to sign a written informed consent document. Informed consent must be provided prior to any study specific procedures\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements",{"count":334,"type":21},22,[53],"This phase II trial studies whether \\[18F\\]FTT can be used with positron emission tomography (PET)\u002Fcomputed tomography (CT) imaging to predict treatment response in patients scheduled to receive gemcitabine, cisplatin, and durvalumab (GCD) for newly diagnosed cholangiocarcinoma. PET\u002FCT is an imaging technique that utilizes PET and CT in a single machine. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this trial, \\[18F\\]FTT, to make detailed, computerized pictures of areas inside the body where the tracer is used. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in the patient's body. \\[18F\\]FTT targets and binds to poly (ADP-ribose) polymerase 1 (PARP1). Some cholangiocarcinoma tumor cells may express PARP1 which may make it easier to see them on PET\u002FCT. Research has shown that tumor cells that express PARP1 may not respond well to GCD treatment. Researchers hope that by using \\[18F\\]FTT with PET\u002FCT imaging they will be able to detect which patients have tumor cells that express PARP1, which may help predict treatment response in patients scheduled to receive GCD for newly diagnosed cholangiocarcinoma.",[338],"Cholangiocarcinoma","2026-08-12",{"date":285,"type":34},{"date":342,"type":21},"2026-11-01",{"date":191,"type":21},{"name":40,"class":41},{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":22,"phases":353,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":359,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":365},"100555897","phase-2-hippocampal-avoidance-in-craniospinal-irradiation-for-the-treatment-of-leptomeningeal-metastases-from-breast-cancer-or-non-small-cell-lung-cancer-100555897","NCT06518057","Hippocampal Avoidance in Craniospinal Irradiation for the Treatment of Leptomeningeal Metastases From Breast Cancer or Non-small Cell Lung Cancer","A Multi-Center Phase 2 Study of Hippocampal Avoidance in Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumors","Inclusion Criteria:\n\n* Patients with breast cancer or NSCLC malignancies with leptomeningeal metastases established radiographically and\u002For through CSF cytology\n* Patients who are candidates for radiation therapy for the treatment of leptomeningeal metastases\n* Patients ≥ 18 years old\n* Karnofsky performance status (KPS) ≥ 60 or Eastern Cooperative Oncology Group (ECOG) ≥ 2\n* The patient is able to provide informed consent\n* Hemoglobin \\> 8 g\u002FdL\n* Absolute neutrophil count \\> 1,000\u002Fmm\n* Platelet count \\> 100,000\u002Fmm\n* Participants born female at birth must either be of non-reproductive potential (i.e. post-menopausal by history \\[≥ 60 years old, or with no menses for \\> 1 year without an alternative medical cause\\], OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum \u002Furine pregnancy test within 3 weeks prior to starting radiation therapy (RT)\n* Patients with reproductive potential must agree to practice two highly effective contraceptive methods\n\nExclusion Criteria:\n\n* Patients with multiple, serious major neurologic deficits per physician\u002Finvestigator assessment including encephalopathy\n* Patients with extensive systemic disease and without reasonable systemic treatment options\n* Patients who are unable to undergo MRI brain and spine with gadolinium contrast\n* Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances\n* Gross ventricular disease\n* Brain metastases within 5 mm of the hippocampal contours not previously treated\n* Pregnant or lactating women",{"count":334,"type":21},[53],"This phase II clinical trial studies how well craniospinal irradiation (CSI) with hippocampal avoidance, using proton therapy or volumetric modulated arc therapy (VMAT), works in treating patients with breast cancer or non-small cell lung cancer (NSCLC) that has spread from the original (primary) tumor to the cerebrospinal fluid (CSF) and meninges (thin layers of tissue that cover and protect the brain and spinal cord) (leptomeningeal metastases). Radiation therapy is an effective treatment in relieving localized symptoms caused by leptomeningeal metastases. However, the type of radiation therapy typically used does not prevent the spread of leptomeningeal disease. CSI (radiation therapy directed at the brain and spinal cord to kill tumor cells) may be able to target all of the areas of possible leptomeningeal tumor spread. CSI may however result in significant neurological side effects due to radiation damage to a part of the brain called the hippocampus. Hippocampal avoidance (HA) reduces the amount of radiation to the hippocampus. Proton or VMAT CSI with HA may be an effective treatment while reducing neurological side effects for patients with leptomeningeal metastases from breast cancer and NSCLC.",[356,357,57,358,60],"Anatomic Stage IV Breast Cancer AJCC v8","Metastatic Breast Carcinoma","Metastatic Malignant Neoplasm in the Leptomeninges",{"date":285,"type":34},{"date":361,"type":34},"2025-03-03",{"date":363,"type":21},"2028-07-01",{"name":40,"class":41},3,{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":22,"phases":375,"briefSummary":376,"conditions":377,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":42},"100610170","phase-2-dose-adjusted-epoch-with-or-without-rituximab-plus-ponatinib-for-the-treatment-of-newly-diagnosed-philadelphia-chromosome-positive-acute-lymphoblastic-leukemialymphoma-100610170","NCT07224100","Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib for the Treatment of Newly-Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia\u002FLymphoma","Phase II Study of Dose-Adjusted EPOCH ± Rituximab + Ponatinib for Adults With Newly-Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia\u002FLymphoma","Inclusion Criteria:\n\n* Adults (age 18 years and older) with newly-diagnosed Ph+ B-ALL. Ph status will be determined by routine cytogenetics, fluorescence in situ hybridization (FISH), and\u002For reverse transcriptase-polymerase chain reaction (RT-PCR) for the BCR::ABL1 translocation\n* Marrow or blood involvement by abnormal lymphoblasts detectable by multiparameter flow cytometry (MFC)\n* Total bilirubin (TBili) ≤ 1.5 x upper limit of normal (ULN) (unless attributed to Gilbert's disease or other causes of inherited indirect hyperbilirubinemia, at which point TBili must be ≤ 4 x ULN)\n\n  * (Note: Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the TBili is ≤ 5 x ULN)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 2.5 x institutional ULN\n\n  * (Note: Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the ALT\u002FAST are ≤ 8 x ULN)\n* Calculated creatinine clearance of \\> 30 ml\u002Fmin\u002F1.73m\\^2, as measured by the Modification of Diet in Renal Disease (MDRD) equation, will be eligible\n* As patients with ALL frequently have cytopenias, no hematologic parameters will be required for enrollment or to receive the first cycle of treatment. However, adequate recovery of blood counts will be required to receive subsequent cycles\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. (Performance status of 3 will be allowed if poor performance status is thought to be directly secondary to ALL)\n* Ability to give informed consent and comply with the protocol\n* Anticipated survival of at least 3 months, independent of ALL\n* Female subjects of reproductive potential must agree to use an effective method of birth control from the time of signing the consent form until one of the following:\n\n  * For subjects not expected to receive rituximab (i.e., CD20-negative): at least 3 weeks after the last dose of ponatinib, or\n  * For subjects expected to receive rituximab (i.e., CD20-positive): at least 12 months after the last dose of rituximab\n  * A subject does not have reproductive potential if they are (1) surgically sterilized, or (2) postmenopausal (i.e., a female who is \\> 50 years old or who has not had menses for ≥ 1 year), or (3) not heterosexually active\n* Male subjects must agree to use an effective method of birth control and to not donate sperm from the time of signing the consent form until at least 3 weeks after the last dose of ponatinib\n\nExclusion Criteria:\n\n* Burkitt lymphoma\u002Fleukemia\n* No prior systemic therapy for ALL except to control acute symptoms and\u002For hyperleukocytosis (e.g., corticosteroids, cytarabine, etc.)\n* No isolated extramedullary or known parenchymal central nervous system (CNS) disease\n* History of acute pancreatitis within 1 year of enrollment or known chronic pancreatitis\n* Symptomatic atherosclerotic cardiovascular disease (e.g., myocardial infarction, cerebrovascular accident, peripheral arterial disease, etc.) within 1 year of enrollment\n* Active resistant hypertension, defined as having an ambulatory blood pressure above goal despite use of 3 antihypertensive medications from different classes\n* Venous thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months of enrollment\n* Known hypersensitivity or intolerance to any of the agents under investigation\n* Other medical or psychiatric conditions that in the opinion of the investigator would preclude safe participation in the protocol\n* May not be pregnant or nursing. Pregnancy test is only required in females, unless they do not have reproductive potential. For subjects not expected to receive rituximab (i.e., CD20-negative), nursing can occur 1 week after the last dose of ponatinib. For subjects expected to receive rituximab (i.e., CD20-positive), nursing can occur 6 months after the last dose of rituximab",{"count":374,"type":21},33,[53],"This phase II trial tests the effect of dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (DA-EPOCH) with or without rituximab plus ponatinib in treating patients newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia or lymphoma (ALL). Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill cancer cells. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Doxorubicin is a drug that is used to treat many types of cancer and is being studied in the treatment of other types of cancer. Doxorubicin comes from the bacterium Streptomyces peucetius. It damages DNA and may kill cancer cells. It is a type of anthracycline antitumor antibiotic. DA-EPOCH involves a longer exposure time to doxorubicin, vincristine and etoposide compared to a higher concentration over a shorter time which may provide better tumor response. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Ponatinib blocks BCR::ABL1 and other proteins, which may help keep cancer cells from growing and may kill them. It may also prevent the growth of new blood vessels that tumors need to grow. Ponatinib is a type of tyrosine kinase inhibitor and a type of antiangiogenesis agent. Giving DA-EPOCH with or without rituximab plus ponatinib may be safe, tolerable, and\u002For effective in treating patients with newly diagnosed Ph+ ALL.",[378,379,380],"B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1","B Lymphoblastic Leukemia\u002FLymphoma With t(9;22)(q34.1;q11.2); BCR-ABL1","Lymphoblastic Lymphoma","2026-08-11",{"date":319,"type":34},{"date":384,"type":34},"2026-03-30",{"date":386,"type":21},"2028-07-31",{"name":40,"class":41},{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":22,"phases":398,"briefSummary":399,"conditions":400,"keywords":404,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":410,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":222},"100571630","stroke-and-cpap-outcome-study-3-randomized-controlled-trial-100571630","NCT06722755","Stroke and CPAP Outcome Study 3 Randomized Controlled Trial","Optimizing Adherence to the Treatment of Sleep Apnea Among Patients With Stroke Undergoing Inpatient Rehabilitation","SCOUTS3","Inclusion criteria include:\n\n1. Age 18 years or older\n2. Head CT or brain MRI demonstrating an acute ischemic infarction or intraparenchymal hemorrhage within past 30 days\n3. Person providing consent (patient or legally authorized representative (LAR)) able to be consented in English or Spanish.\n\nExclusion criteria include:\n\n1. Unable to obtain informed consent from participant or LAR in English or Spanish\n2. Incarcerated\n3. Known pregnancy-determined by reviewing clinical data\n4. Current mechanical ventilation, tracheostomy, or supplemental oxygen use \\> 4L\u002Fmin\n5. Use of positive airway pressure within 14 days prior to stroke\n6. History of pneumothorax, bullous emphysema or other serious co-morbid conditions which limit CPAP use\n7. Stroke related to tumors, vascular malformations or subarachnoid hemorrhage\n8. Active use of sedative drugs that can interfere with testing for obstructive sleep apnea (OSA) including any benzodiazepine, barbiturate, general anesthesia, or conscious sedation within the prior 48 hours of the planned portable sleep apnea study\n9. Anticipated inpatient rehabilitation length of stay \\\u003C 5 nights\n10. Co-morbid conditions that limit OSA testing or CPAP use in the judgement of the study team\n11. Recent cranial or spinal surgery with known or possible CSF leak or pneumocephalus within past 3 months\n12. Patients at significant risk of aspiration that could render the patient at risk of harm from use of CPAP, in the opinion of the site PI.",{"count":397,"type":21},250,[102],"The SCOUTS 3 study aims to test the effectiveness of an intensive CPAP (Continuous Positive Airway Pressure) therapy support program compared to usual care in stroke patients with obstructive sleep apnea (OSA) during inpatient rehabilitation (IPR).\n\nThe study is a multicenter randomized controlled trial (RCT) involving recruitment of about 250 participants across two institutions and randomization of about 200 participants. It compares an intensive support (IS) program for CPAP use with standard support (SS) to evaluate the effectiveness of the IS intervention in increasing CPAP usage during and after stroke rehabilitation. The Intensive Support (IS) group will receive a multicomponent intensive behavioral adherence program, which includes a CPAP technical support intervention, Motivational Enhancement Therapy (MET), and a Mobile Health intervention. Outcomes measured include CPAP adherence as measured by average nightly use in minutes between randomization and 3 months and the modified Rankin Scale (mRS-9Q) to evaluate stroke recovery.",[401,402,403],"Stroke Patients","CPAP","OSA - Obstructive Sleep Apnea",[405,406,407,408,409],"behavioral therapy","continuous positive airway pressure","stroke recovery","self determination","sleep apnea",{"date":319,"type":34},{"date":412,"type":34},"2025-01-15",{"date":414,"type":21},"2028-05",{"name":40,"class":41},{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":22,"phases":425,"briefSummary":426,"conditions":427,"keywords":428,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":430,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":42},"100342387","phase-2-fractionated-gemtuzumab-ozogamicin-in-treating-measurable-residual-disease-in-patients-with-acute-myeloid-leukemia-100342387","NCT03737955","Fractionated Gemtuzumab Ozogamicin in Treating Measurable Residual Disease in Patients With Acute Myeloid Leukemia","A Phase 2 Trial of Fractionated Gemtuzumab Ozogamicin to Eradicate Measurable Residual Disease in Acute Myeloid Leukemia Patients (GO for MRD)","Inclusion Criteria:\n\n* Prior diagnosis AML based on 2016 World Health Organization criteria. Acute promyelocytic leukemia (APL) and biphenotypic AML are not eligible\n* Patients must have MRD-level disease only and otherwise meet criteria for complete response (CR) or complete remission with incomplete hematologic recovery (CRi) per the 2017 European Leukemia Net response criteria (\\\u003C 5% blasts in the marrow without a requirement for peripheral blood count recovery). MRD must be measurable by multiparameter flow cytometry (MPFC) and\u002For polymerase chain reaction (PCR)-based molecular markers and\u002For karyotypic markers (e.g., classical cytogenetics or fluorescence in situ hybridization). MRD status will be centrally confirmed by the UW\u002FFHCRC clinical laboratory in order to standardize response assessment following administration of study therapy.\n* Patients must have received at least 1 cycle of standard induction chemotherapy prior to enrollment on the study. However, adult patients (\\>= 18 years of age) are eligible for participation at any time point in treatment (after induction, during or after consolidation, pre-transplant, or post-transplant).\n* Age \\>= 18 years of age\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 3\n* Patient's AML blasts must have CD33 expression.\n* For adults (\\>= 18 years of age): Serum creatinine =\\\u003C 2.0 mg\u002FdL.\n* For adults (\\>= 18 years of age): Total bilirubin =\\\u003C 2 x institutional upper limit of normal for age (unless known history of Gilbert's disease).\n* For adults (\\>= 18 years of age): Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 2.5 x institutional upper limit of normal for age (unless thought to be related to resolving infectious complications).\n* Ability of patient to provide written informed consent.\n* Females of childbearing potential must have a negative pregnancy test prior to receiving GO.\n* Patients who re-enroll must have achieved an MRD-negative CR during their prior enrollment\n\nExclusion Criteria:\n\n* Subjects who have had chemotherapy or radiation therapy within 14 days prior to entering the study.\n* Subjects may not be receiving other investigational agents.\n* Uncontrolled or concurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.",{"count":424,"type":21},36,[53],"This phase II trial studies the how well fractionated gemtuzumab ozogamicin works in treating measurable residual disease in patients with acute myeloid leukemia. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to a chemotherapy drug, called ozogamicin. Gemtuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD33 receptors, and delivers a chemotherapy known as calicheamicin to kill them.",[235],[429],"Myeloid and Monocytic Leukemia",{"date":319,"type":34},{"date":432,"type":34},"2018-11-30",{"date":434,"type":21},"2026-12-31",{"name":40,"class":41},{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":201,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":22,"phases":444,"briefSummary":445,"conditions":446,"keywords":451,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":222},"100630667","nuestro-valor-increasing-healthier-food-access-for-rural-latino-communities-through-a-food-retail-intervention-100630667","NCT07490652","Nuestro Valor: Increasing Healthier Food Access for Rural Latino Communities Through a Food Retail Intervention","Inclusion criteria:\n\nIn order for an individual to participate in this study, the individual must meet all of the following criteria:\n\n* Identify as Latino or Hispanic\n* Be at least 18 years or older\n* Live in Benton, Franklin, or Yakima county for at least 6 months and plan to remain there for the next 12 months\n* Visit this store at least once per week\n* Be primary household shopper (conducting 50% of shopping duties)\n* Eat 4 or less servings of fruits and vegetables per week Only one participant per household will be recruited to ensure the independence of observations.\n\nExclusion criteria:\n\nSubjects who do not meet the inclusion criteria above will be excluded from the study. If any subject shows 3 or more visual signs of intoxication or impairment, they will be excluded from the study. The study team member will assess visual signs of intoxication during recruitment using the Oregon Liquor \\& Cannabis Commission 50 Signs of Visual Intoxication assessment. A link to these signs can be found here: https:\u002F\u002Fwww.oregon.gov\u002Folcc\u002Fdocs\u002Fpublications\u002F50\\_signs\\_visible\\_intoxication.pdf",{"count":443,"type":21},400,[102],"The goal of this clinical trial is to adapt and implement The Value of Our Health (Our Value), a program to promote eating fruit and vegetables, for people living in rural areas. The program will be offered in small, independent grocery stores and delivered by community health workers. The main question this study will answer is: Do customers who shop at stores receiving Our Value eat more fruits and vegetables than customers of other stores?",[447,448,449,450],"Hispanic Americans","Chronic Disease Prevention","Cancer Prevention","Fruit and Vegetable Consumption",[447,452,450,449,448,453],"Rural Population","Latino Health","2026-08-10",{"date":339,"type":34},{"date":457,"type":34},"2026-04-17",{"date":459,"type":21},"2029-05",{"name":40,"class":41},{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":468,"minAge":18,"maxAge":4,"enrollmentInfo":469,"targetDuration":4,"studyType":22,"phases":471,"briefSummary":472,"conditions":473,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":477,"startDateStruct":478,"completionDateStruct":479,"leadSponsor":481,"locationsCount":42},"100628811","phase-2-estrogen-to-improve-quality-of-life-for-men-with-newly-diagnosed-or-recurrent-metastatic-hormone-sensitive-prostate-cancer-equip-trial-100628811","NCT07466498","Estrogen to Improve Quality of Life for Men With Newly Diagnosed or Recurrent Metastatic Hormone Sensitive Prostate Cancer, EQUIP Trial","Estrogen for Quality-of-Life and Immune Modulation in Prostate Cancer (EQUIP)","Inclusion Criteria:\n\n* Must be willing to provide informed consent prior to any study specific procedures\n* Age ≥ 18 years\n* Documented histologically confirmed adenocarcinoma of the prostate\n* Patients must have evidence of newly diagnosed or relapsed metastatic hormone sensitive prostate cancer on CT, positron emission tomography (PET), MRI or bone scan\n* No prior chemotherapy for the treatment of hormone sensitive prostate cancer\n* No prior therapy with an LHRH analogue or next-generation androgen receptor-signaling inhibitor (e.g. abiraterone, enzalutamide, etc.). Participants may have initiated on a first-generation androgen receptor (AR) antagonist (e.g. bicalutamide) prior to enrollment\n* Hemoglobin ≥ 9 g\u002FdL with no blood transfusion in the past 28 days (measured within 30 days prior to administration of study treatment)\n* Platelet count ≥ 100 x 10\\^9\u002FL (measured within 30 days prior to administration of study treatment)\n* Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL (measured within 30 days prior to administration of study treatment)\n* Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT)\u002Falanine aminotransferase (ALT) or serum glutamic pyruvate transaminase (SGPT) ≤ 2.5 x institutional upper limit of normal (measured within 30 days prior to administration of study treatment)\n* Patient must have creatinine clearance estimated using the Cockcroft-Gault equation (measured within 30 days prior to administration of study treatment)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) with exception for Gilbert's syndrome (measured within 30 days prior to administration of study treatment)\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Patients must have a life expectancy ≥ 16 weeks\n* Patients must be willing and able to comply with protocol for the duration of the study including undergoing treatment and scheduled visits and examinations\n* At least one lesion (measurable and\u002For non-measurable) that can be accurately assessed at baseline by CT, MRI and\u002For bone scan and is suitable for repeated assessment. Subjects without bone metastases must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1\n* Male patients and their partners, who are sexually active and of childbearing potential, must agree to the use of two highly effective forms of contraception in combination, throughout the period of taking study treatment and for 6 months after last dose of study drug(s) to prevent pregnancy in a partner\n\nExclusion Criteria:\n\n* Involvement in the planning and\u002For conduct of the study\n* Other malignancy unless curatively treated with no evidence of disease for ≥ 2 years. Exceptions include adequately treated non-melanoma skin cancer or non-muscle invasive bladder cancer\n* Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. Patient with spinal cord compression unless considered to have received definitive therapy for this and evidence of clinically stable disease for 28 days\n* Patients considered inappropriate to receive docetaxel chemotherapy by their treating provider\n* Use of corticosteroids at a dose equivalent to \\> 10 mg of prednisone daily\n* Planning to receive concurrent treatment with another systemic cancer therapy, aside from an LHRH analogue\n* Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery\n* Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, uncontrolled major seizure disorder, uncontrolled hypertension (blood pressure \\[BP\\] ≥ 165\u002F100), unstable spinal cord compression, superior vena cava syndrome or extensive interstitial lung disease\n* Patients with a known hypersensitivity to transdermal estradiol, LHRH analogue, ARSIs or any of the excipients of these products\n* Patients with known active hepatitis (i.e., hepatitis B or C) due to risk of transmitting the infection through body or other body fluids\n* Evidence of serious and\u002For unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study\n* Any psychological, familial, sociological or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule\n* Evidence of a pre-existing condition that, in the opinion of the investigator, would put the patient at risk from estradiol therapy.\n\n  * Some examples include: history of blood clotting disorder, migraines with aura or other focal neurological symptom, angina (New York Heart Association grade III or higher)\n* Prior history of deep venous thrombosis or pulmonary embolism within 5 years prior to enrollment in the study and not currently on systemic anticoagulation\n\n  * Excluded due to risk of venous thromboembolism from hormone supplementation\n* Patients with New York Heart Association (NYHA) class III or IV heart failure or history of a prior myocardial infarction (MI) or cerebrovascular accident (stroke or transient ischemic attack) within 5 years of enrollment to the study\n\n  * Excluded due to increased risk of cardiovascular events with estradiol supplementation","MALE",{"count":470,"type":21},60,[53],"This phase II trial compares giving estrogen with an androgen receptor signaling inhibitor to standard of care luteinizing hormone-releasing hormone (LHRH) analogues with an androgen receptor signaling inhibitor for improving quality of life for patients with hormone sensitive prostate cancer that is newly diagnosed or that has come back after a period of improvement (recurrent) and has spread from where it first started (primary site) to other places in the body (metastatic). Standard prostate cancer treatment decreases hormone levels, specifically estrogen, in the body which can lead to hot flashes, fatigue, decreased bone health, and cardiovascular and metabolic dysfunction. Transdermal estrogen may help to alleviate these symptoms. Androgen receptor signaling inhibitors work by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. LHRH analogues are a type of androgen deprivation therapy that blocks the use of androgen by the tumor cells. Giving estrogen with androgen receptor signaling inhibitor may improve quality of life in men with newly diagnosed or recurrent metastatic hormone sensitive prostate cancer.",[474,475,476],"Castration-Sensitive Prostate Adenocarcinoma","Metastatic Castration-Sensitive Prostate Adenocarcinoma","Stage IVB Prostate Cancer AJCC v8",{"date":339,"type":34},{"date":342,"type":21},{"date":480,"type":21},"2029-06-01",{"name":40,"class":41},{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":468,"minAge":18,"maxAge":4,"enrollmentInfo":489,"targetDuration":4,"studyType":491,"phases":4,"briefSummary":492,"conditions":493,"keywords":497,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":499,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":505},"100400091","impact-of-dna-repair-pathway-alterations-on-sensitivity-to-radium-223-in-bone-metastatic-castration-resistant-prostate-cancer-100400091","NCT04489719","Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer","The Impact of DNA Repair Pathway Alterations Identified by Circulating Tumor DNA on Sensitivity to Radium-223 in Bone Metastatic Castration-Resistant Prostate Cancer","Inclusion Criteria:\n\n* Patient must be \\>= 18 years of age\n* Patient must have histopathologic diagnosis of prostate cancer\n* Patient must have castration-resistant prostate cancer\n* Patient must have radiographic evidence of bone metastasis\n* Patients must be symptomatic from prostate cancer\n* Patient must have plans to undergo treatment with radium-223\n* Patient must have a PSA level \\>= 10 ng\u002FmL\n* Patient must have castrate testosterone levels demonstrated within the last 3 months prior to screening\n* Patient must have anticipated survival \\> 3 months\n* Patient must be willing and able to authorize consent\n* Patient must be willing and able to comply with the protocol, including follow-up visits\n\nExclusion Criteria:\n\n* Patient must not have visceral metastasis\n* Patients on regimens of radium-223 in combination with other antineoplastic agents are excluded\n\n  \\* Bone-targeted only therapy (e.g. denosumab or zoledronic acid) will be allowed\n* Patients who have received prior radium-223\n* Patients who have received prior platinum containing chemotherapy\n* Absolute neutrophil count (ANC) \\\u003C 1.5 x 10\\^9\u002FL\n* Hemoglobin (HB) \\\u003C 9 g\u002FdL\n* Platelets (PLT) \\\u003C 100 x 10\\^9\u002FL\n* Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation",{"count":490,"type":21},48,"OBSERVATIONAL","This study investigates how well radium-223 works in treating patients with castration-resistant prostate cancer than has spread to the bones (bone metastases). Prostate cancer is the most common cancer in men and the second leading cause of cancer death. Furthermore, many men with notably advanced disease have been found to have abnormalities in DNA repair. The purpose of this research is to study the role of a DNA repair pathway in prostate cancer, specifically in response to administration of radium-223, an FDA-approved drug known to cause DNA damage to cancerous cells. Understanding how defects in the DNA repair pathway affects radium-223 treatment of prostate, may help doctors help plan effective treatment in future patients.",[494,495,496,476],"Castration-Resistant Prostate Carcinoma","Metastatic Malignant Neoplasm in the Bone","Metastatic Prostate Carcinoma",[498],"Prostate",{"date":339,"type":34},{"date":501,"type":34},"2021-04-16",{"date":503,"type":21},"2030-08-01",{"name":40,"class":41},4,{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":22,"phases":515,"briefSummary":516,"conditions":517,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":525,"leadSponsor":527,"locationsCount":42},"100641890","phase-1-consolidative-therapy-after-ev--pembrolizumab-in-muscle-invasive-bladder-cancer-reinforce-trial-100641890","NCT07579195","Consolidative Therapy After EV + Pembrolizumab in Muscle Invasive Bladder Cancer, REINFORCE Trial","Consolidative Radiation Therapy or Cystectomy After Initial Favorable Response Succeeding Enfortumab Vedotin Plus Pembrolizumab (REINFORCE)--- A Pilot Feasibility Trial","Inclusion Criteria:\n\n* Age \\>= 18 at the time of screening\n* Ability to understand and willingness to sign a written informed consent document\n* Histopathologically confirmed cTxN1-3M0, cTxNxM1 or cT4bNxM0 muscle invasive bladder cancer at initial diagnosis\n* Achieved a radiographic complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria and at the determination of treating physicians) after 3-9 cycles of induction EV + pembro\n* If M1 after completion of EV + pembro, patients need to have =\\\u003C 5 sites of metastasis and all sites of metastasis should be extracranial\n\n  * Note: when counting the number of oligometastatic lesions, each lymph node lesion, whether pelvic or extrapelvic, is counted (for example, 2 distinct lymph nodes in the right external iliac basin count as 2 oligometastatic lesions; one extrapelvic and one pelvic node count as 2 oligometastatic lesions, etc). Five or fewer sites of metastasis applies after the completion of EV + pembro, not at initial diagnosis\n* Be a candidate for consolidative radiation therapy (RT) to the pelvis (if indicated) or cystectomy (if indicated), and all sites of metastasis are amenable to RT\n* Life expectancy \\> 6 months\n* Eastern Cooperative Oncology Group (ECOG) performance 0-2\n* Absolute neutrophil count (ANC) \\>= 1500 \u002FmcL (within 180 days of trial registration)\n* Platelets \\>= 100,000\u002FmcL (within 180 days of trial registration)\n* Hemoglobin \\> 9 g\u002FdL (within 180 days of trial registration)\n* Creatinine =\\\u003C 1.5 x upper limit of normal (ULN) OR \\>= 60 mL\u002Fmin (within 180 days of trial registration)\n* Total bilirubin =\\\u003C 1.5 ULN OR direct bilirubin =\\\u003C ULN if total bilirubin \\> 1.5 x ULN (within 180 days of trial registration)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN OR \\\u003C 5 x ULN if patient has live metastasis (within 180 days of trial registration)\n* Albumin \\>= 2.5 g\u002FdL (within 180 days of trial registration)\n* International normalized ratio (INR) or prothrombin time (PT) =\\\u003C 1.5 x ULN unless on anticoagulation therapy, in which case PT or partial thromboplastin time (PTT) should be in the therapeutic range (within 180 days of trial registration)\n* PTT =\\\u003C 1.5 x ULN unless on anticoagulation therapy, in which case PT or PTT should be in the therapeutic range (within 180 days of trial registration)\n* Participants of child-bearing potential must be willing to employ two highly effective and acceptable forms of contraception during, and for at least 90 days after the end of radiation therapy. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours of treatment initiation\n* HIV-infected patients who are healthy and have a low risk of AIDS-related outcomes are included in this trial\n\nExclusion Criteria:\n\n* Prior radiation therapy with field overlapping with current proposed radiation field, precluding delivery of meaningful dose of radiation\n* Intracranial metastasis\n* Any small cell component, or predominant (\\> 50%) sarcomatoid or plasmacytoid histology\n* Other active malignancy or clinically relevant malignancy within past 2 years, per discussion with the principal investigator\n* Genetic conditions that increase sensitivity to radiation, such as Fanconi syndrome, ataxia telangiectasia, and Nijmegen breakage syndrome\n* Active human immunodeficiency virus (HIV) not adequately controlled, active hepatitis B (e.g., hepatitis B virus surface antigen \\[HBsAg\\] reactive) or hepatitis C (e.g., hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] \\[qualitative\\] is detected), as determined by standard of care testing\n* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Any other medical condition that may interfere with trial therapy delivery\n* Adults with impaired decision-making capacity, as determined by the treating physician",{"count":514,"type":21},12,[24,53],"This pilot feasibility clinical trial is evaluating a novel treatment strategy for patients with advanced bladder cancer that is unresectable, has spread to nearby lymph nodes or a limited number of distant sites (oligometastatic disease), and has responded to initial treatment with enfortumab vedotin and pembrolizumab. Although this combination has significantly improved outcomes compared to traditional chemotherapy, many patients are left with residual cancer in the bladder or other sites, and there is currently no established standard approach for managing this remaining disease or determining the optimal duration of systemic therapy. Prolonged treatment can lead to cumulative side effects and negatively impact quality of life.\n\nThis study investigates whether adding consolidative treatment-such as radiation therapy to the bladder and metastatic sites or surgical removal of the bladder (radical cystectomy)-can safely eliminate residual disease and delay cancer progression. Radiation therapy uses high-energy x-rays to precisely target and destroy cancer cells while minimizing exposure to surrounding normal tissues. In selected patients, surgery may be used to remove remaining tumor in the bladder. Targeted radiation techniques, such as stereotactic body radiation therapy (SBRT), may also be used to treat small metastatic sites. This approach may allow for safe discontinuation of systemic therapy, potentially reducing long-term treatment-related side effects.\n\nA key component of this trial is the integration of biomarker testing using circulating tumor DNA (ctDNA) from blood and urine tumor DNA (utDNA). These tests detect small amounts of tumor-derived genetic material and may help identify patients most likely to benefit from consolidative treatment, as well as guide decisions about ongoing therapy. By combining response to systemic therapy with personalized local treatment and biomarker-driven monitoring, this study aims to improve cancer control, reduce complications from untreated local disease, and inform future treatment strategies for patients with advanced bladder cancer.",[518,519,520],"Muscle Invasive Bladder Carcinoma","Stage III Bladder Cancer AJCC v8","Stage IV Bladder Cancer AJCC v8","2026-08-05",{"date":523,"type":34},"2026-08-06",{"date":65,"type":21},{"date":526,"type":21},"2030-02-01",{"name":40,"class":41},{"id":529,"slug":530,"hasResults":12,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":4,"eligibilityCriteria":534,"healthyVolunteers":12,"sex":122,"minAge":18,"maxAge":4,"enrollmentInfo":535,"targetDuration":4,"studyType":22,"phases":537,"briefSummary":538,"conditions":539,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":545,"leadSponsor":547,"locationsCount":42},"100631011","phase-2-igfbp-2-vaccine-to-prevent-ovarian-cancer-progression-in-patients-with-serologic-detection-of-recurrence-100631011","NCT07495124","IGFBP-2 Vaccine to Prevent Ovarian Cancer Progression in Patients With Serologic Detection of Recurrence","A Phase II Study of (IGFBP-2) Vaccine to Prevent Progression After Serologic Detection of Recurrent Ovarian Cancer","Inclusion Criteria:\n\n* Have a diagnosis of ovarian, fallopian tube, or primary peritoneal cancer who have received systemic chemotherapy including platinum-based chemotherapy\n* Have a cancer antigen 125 (CA-125) that normalized after first-line therapy\n* CA-125 increased to more than twice the upper limit of normal or two times the nadir value after most recent second or later line of treatment\n* Have no measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Ascites and pleural effusions are not measurable disease, if asymptomatic\n* All patients who are having sex that can lead to pregnancy must agree to contraception for the duration of the study (end of one year follow up). Note: Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or postmenopausal\n* Have estimated life expectancy of at least 3 months\n* Be willing and able to provide written informed consent\u002Fassent for the trial\n* Be ≥ 18 years of age on day of signing informed consent\n* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale\n* White blood cell (WBC) ≥ 3000\u002Fmm\\^3 (performed within 14 days of treatment initiation)\n* Hemoglobin (Hgb) ≥ 10 g\u002Fdl (performed within 14 days of treatment initiation)\n* Hematocrit (Hct) ≥ 28% (performed within 14 days of treatment initiation)\n* Serum creatinine ≤ 2.0 mg\u002Fdl or creatinine clearance \\> 60 mL\u002Fmin (performed within 14 days of treatment initiation)\n* Total bilirubin ≤ 2.5 mg\u002Fdl (performed within 14 days of treatment initiation)\n* Aspartate aminotransferase (AST) ≤ 3 times upper limit of normal (ULN) (performed within 14 days of treatment initiation)\n* Blood glucose \\\u003C 1.5 ULN (performed within 14 days of treatment initiation)\n\nExclusion Criteria:\n\n* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of treatment (i.e., day 1)\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (if dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment\n\n  * Short-term administration of systemic steroids (i.e., for allergic reactions or the management of immune-related adverse events \\[irAEs\\]) is allowed\n* Has symptomatic ascites or pleural effusions\n* History of borderline or low malignant potential ovarian cancer\n* Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier\n* Has had prior chemotherapy, biologic therapy, targeted small molecule therapy, hormonal therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to a previously administered agent\n\n  * Note: Patients with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study\n  * Note: If a patient received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 14 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability\n* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* Has an active infection requiring systemic therapy\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator\n* Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment\n* Clinically significant cardiovascular disease\n* Known severe hypersensitivity reactions to carboplatin ≥ grade 3, any history of anaphylaxis, or uncontrolled asthma\n* Patients with any contraindication to receiving recombinant human granulocyte macrophage-colony stimulating factor (rhuGM-CSF) based products\n* Has a known history of human immunodeficiency virus (HIV) (HIV 1\u002F2 antibodies)\n* Has known active hepatitis B (e.g., hepatitis B virus surface antigen \\[HBsAg\\] reactive) or hepatitis C (e.g., hepatitis c virus \\[HCV\\] ribonucleic acid \\[RNA\\] \\[qualitative\\] is detected)\n* Has received a live vaccine or live-attenuated vaccine within 30 days of planned start of study therapy. Administration of killed vaccines is allowed\n\n  * Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed",{"count":536,"type":21},26,[53],"This phase II trial studies how well giving the insulin-like growth factor binding protein 2 \\[pUMVC3-hIGFBP-2 multi-epitope plasmid deoxyribonucleic acid (DNA) (IGFBP-2)\\] vaccine after one dose of carboplatin works to stop ovarian cancer from growing, spreading, or getting worse (progressing) in patients whose cancer recurrence is detected only in the blood (serologic detection) following treatment with platinum chemotherapy. IGFBP-2 is a protein found in ovarian cancer cells. The IGFBP-2 vaccine may help the body build an effective immune response to kill tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It has been shown to activate parts of the immune system that may act against tumors. Giving the IGFBP-2 vaccine after a single dose of carboplatin may be an effective way to stop ovarian cancer from progressing in patients with serologic detection following treatment with platinum chemotherapy.",[540,541,542],"Fallopian Tube Carcinoma","Ovarian Carcinoma","Primary Peritoneal Carcinoma",{"date":523,"type":34},{"date":65,"type":21},{"date":546,"type":21},"2028-09-30",{"name":40,"class":41},{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":4,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":555,"targetDuration":4,"studyType":22,"phases":557,"briefSummary":558,"conditions":559,"keywords":560,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":42},"100374167","petct-changes-during-chemoimmunotherapy-and-radiation-therapy-in-patients-with-stage-iv-non-small-cell-lung-cancer-100374167","NCT04151940","PET\u002FCT Changes During Chemoimmunotherapy and Radiation Therapy in Patients With Stage IV Non-small Cell Lung Cancer","An Interventional Study of PET\u002FCT Changes During Chemoimmunotherapy and Radiation Therapy for Patients With Metastatic NSCLC (PET Bright)","Inclusion Criteria:\n\n* Histologically-confirmed or cytologically-confirmed metastatic NSCLC in patients who have not received chemotherapy or immunotherapy for their advanced disease (stage IV or recurrent, using the American Joint Committee on Cancer \\[AJCC\\]\u002FUnion for International Cancer Control \\[UICC\\] 8th edition for staging)\n* Evidence of stage IV disease on imaging by CT, PET\u002FCT, or magnetic resonance imaging (MRI)\n* Plan to treat with a platinum doublet with a PD1 or PDL1 inhibitor\n* Adjuvant chemotherapy or concurrent chemoradiation for early stage disease does not count as prior therapy unless subject progressed within 6 months of completion of regimen.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1, at treating physician's discretion\n* Subjects must be ≥ 18 years of age\n* Patients with known activating mutations in EGFR, BRAF or known translocation in ALK or ROS-1 are eligible provided they have progressed on or were intolerant to Food and Drug Administration (FDA) approved targeted therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2\n* Creatinine =\\\u003C 2 mg\u002FdL or creatinine clearance \\> 50 mL\u002Fmin\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 5x institutional upper limit of normal\n* Total bilirubin =\\\u003C 1.5 mg\u002FdL\n* Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL (\\>= 1500 per mm\\^3)\n* Platelet count \\>= 100 x 10\\^9\u002FL (\\>=100,000 per mm\\^3)\n* Capability to understand and comply with the protocol requirements and signed informed consent documents\n\nExclusion Criteria:\n\n* Any known additional malignancy (with exception of non-melanoma skin cancer, in-situ breast cancer, low risk prostate cancer, or a malignancy diagnosed \\>= 3 years prior to the current NSCLC diagnosis and with no evidence of requiring active treatment)\n* Had prior treatment with an anti-PD-1, or PD-L1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms\n* Has any serious or uncontrolled active infection that could create false positives on a PET\u002FCT scan, in the opinion of the treating investigator\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator\n* Has an active autoimmune disease currently requiring systemic treatment (e.g. disease modifying agents, corticosteroids or immunosuppressive drugs)\n\n  \\*\\*Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* Has known, active, and symptomatic central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n\n  * Patients with stable or previously treated brain metastases are eligible as long as they are not receiving more than 10 mg of prednisone, or equivalent, per day",{"count":556,"type":21},80,[102],"This study investigates the changes in positron emission tomography (PET)\u002Fcomputed tomography (CT) imaging scans during chemoimmunotherapy and radiation therapy treatment in patients with stage IV non-small cell lung cancer. Analyzing changes in PET\u002FCT imaging scans may help doctors assess and predict patterns of cancer response to chemoimmunotherapy and radiation therapy.",[57,58,60],[561],"Lung","2026-08-04",{"date":523,"type":34},{"date":565,"type":34},"2019-09-26",{"date":567,"type":21},"2027-11-30",{"name":40,"class":41},{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":4,"eligibilityCriteria":575,"healthyVolunteers":201,"sex":468,"minAge":18,"maxAge":4,"enrollmentInfo":576,"targetDuration":4,"studyType":491,"phases":4,"briefSummary":578,"conditions":579,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":590,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":595,"locationsCount":42},"100136749","collecting-and-studying-blood-and-tissue-samples-from-patients-with-locally-recurrent-or-metastatic-prostate-or-bladderurothelial-cancer-100136749","NCT01050504","Collecting and Studying Blood and Tissue Samples From Patients With Locally Recurrent or Metastatic Prostate or Bladder\u002FUrothelial Cancer","Molecular Correlates of Sensitivity and Resistance to Therapy in Genitourinary Malignancy","Inclusion Criteria:\n\n* Patients with localized and\u002For metastatic bladder\u002Furothelial or prostate cancer who have disease in the primary organ, biopsy accessible bone metastases (collaborating radiologists will determine if bone metastasis is appropriate for biopsy) or soft tissue metastases are eligible; men and women without cancer are eligible to have blood or normal tissue collected if acquired as part of non-research procedures (e.g. transurethral resection of the prostate or bladder); in patients without malignancy, no additional tissue beyond that necessary for care will be procured\n* Ability to adequately understand and give informed consent\n* Local or metastatic disease to soft tissue or bone at sites accessible to biopsy with minimal risk of complications Or the ability to obtain tissue with minimal risk of complication from a surgical procedure being conducted as a part of another research study Or for standard of care purposes or patients who have archival tissue collected for research or standard of care who are willing to donate archival tissue for this study\n* Alternatively, men and women without cancer or who are at risk of developing cancer are eligible to have blood or normal tissue collected if acquired; tissue will only be acquired as part of non-research procedures (e.g. transurethral resection of the prostate or bladder; in patients without malignancy, no additional tissue beyond that necessary for care will be procured\n* Platelet count \\> 50,000\n* White blood cell (WBC) \\> 1,500\n* Hemoglobin (Hgb) \\> 8.0\n* International normalized ratio (INR) \\\u003C 1.5\n* Partial thromboplastin time (PTT) \\\u003C 45\n* No history of excessive unexplained bleeding from previous surgery\n\nExclusion Criteria:\n\n* Patients unable to stop chronic anticoagulation with warfarin or Lovenox for less than 3 days\n* Serious or uncontrolled infection\n* Treatment with a vascular endothelial growth factor (VEGF) inhibitor (such as Avastin) within the past 28 days",{"count":577,"type":21},1500,"This study collects and studies tissue and blood samples from patients with prostate or bladder\u002Furothelial cancer that has recurred (come back) at or near the same place as the original (primary) tumor or has spread to other parts of the body. Studying samples of blood and tissue samples from patients with prostate or bladder\u002Furothelial cancer in the laboratory may help doctors learn more about new biomarkers, potential drug targets, and resistance developing in response to treatment. It may also help doctors find better ways to treat the cancer.",[580,581,495,582,583,584,585,586,587,588,589],"Localized Renal Pelvis and Ureter Urothelial Carcinoma","Malignant Solid Neoplasm","Metastatic Malignant Neoplasm in the Soft Tissues","Metastatic Renal Pelvis and Ureter Urothelial Carcinoma","Recurrent Bladder Carcinoma","Recurrent Prostate Carcinoma","Recurrent Renal Pelvis and Ureter Urothelial Carcinoma","Stage IV Bladder Cancer AJCC v7","Stage IV Bladder Urothelial Carcinoma AJCC v7","Stage IV Prostate Cancer AJCC v7",{"date":523,"type":34},{"date":592,"type":4},"2009-08",{"date":594,"type":21},"2029-01-31",{"name":40,"class":41},{"id":597,"slug":598,"hasResults":12,"nctId":599,"briefTitle":600,"officialTitle":601,"acronym":4,"eligibilityCriteria":602,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":603,"targetDuration":4,"studyType":22,"phases":605,"briefSummary":606,"conditions":607,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":610,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":614,"locationsCount":42},"100598985","phase-2-a-cancer-vaccine-stemvac-in-combination-with-chemotherapy-for-the-treatment-of-pd-l1-negative-metastatic-triple-negative-breast-cancer-100598985","NCT07078604","A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negative Breast Cancer","A Phase II Trial of the Immunogenicity of a DNA Plasmid-Based Vaccine (STEMVAC) Encoding Th1 Selective Epitopes From Five Antigens Associated With Breast Cancer Stem Cells (MDM2, YB1, SOX2, CDH3, CD105) in Patients With Metastatic Triple-Negative Breast Cancer","Inclusion Criteria:\n\n* Patients must be at least ≥ 18 years of age\n\n  * Note: Because no dosing or adverse event (AE) data are currently available on the use of STEMVAC in patients \\\u003C 18 years of age, children and adolescents are excluded from this study, but will be eligible for future pediatric trials, if applicable\n* Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status Score of ≤ 2\n* Histologically confirmed triple-negative breast cancer\n\n  * Tumors with estrogen receptor (ER)-low (≤ 5%) or negative and progesterone receptor (PR)-low (≤ 5%) or negative will be included\n  * HER2-negative or HER2-low will be defined by the American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) 2023 \"Human Epidermal Growth Factor Receptor 2 (HER2) Breast Testing Guideline Update\" which reaffirms the 2018 \"HER2 Breast Testing Guideline Focused Update\"\n* Tumor is negative for PD-L1 marker testing per standard of care immunohistochemistry 22C3 pharmDx assay\n* Metastatic disease that is measurable based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions\n* Have at least 1 site of disease confirmed by the treating oncologist that could be biopsied during treatment. Lesions that will be biopsied should not be in a previously irradiated area unless progression has been demonstrated in such lesions\n* Patients can not have received any prior cancer immunotherapy in the metastatic setting\n* Prior Food and Drug Administration (FDA)-approved antibody drug conjugates are allowed\n* Patients are appropriate candidates to receive standard of care chemotherapy as per treating oncologist's clinical judgement\n* Patients who have received prior neoadjuvant or adjuvant chemotherapy are allowed\n* A minimum of 14 days washout since last systemic therapy or any palliative radiotherapy is required\n* Treatment with a bisphosphate or denosumab concurrently with protocol-specific therapy is allowed while on study (it is not exclusionary)\n* Patients must be at least 28 days post systemic steroids prior to enrollment, unless this is a steroid administered concurrently with chemotherapy or used as part of prophylaxis to prevent intravenous (IV) contrast reactions\n* Must have recovered from major infections and\u002For surgical procedures; and in the opinion of the investigator, not have any significant active concurrent medical illnesses or condition precluding protocol treatment\n* Willing to undergo up to two serial biopsies while on study\n* White blood cell (WBC) ≥ 2.5 THOU\u002FuL (Within 28 days of receiving first study vaccine)\n* Lymphocyte count ≥ 0.5 THOU\u002FuL (Within 28 days of receiving first study vaccine)\n* Absolute neutrophil count (ANC) ≥ 1.0 THOU\u002FuL (Within 28 days of receiving first study vaccine)\n* Hemoglobin (Hgb) ≥ 9 g\u002FdL (Within 28 days of receiving first study vaccine)\n* Platelets ≥ 75 THOU\u002FuL (Within 28 days of receiving first study vaccine)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert's syndrome in whom total bilirubin must be \\\u003C 3.0 mg\u002Fd (Within 28 days of receiving first study vaccine)\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 1.5 x institutional ULN (Within 28 days of receiving first study vaccine)\n* Creatinine ≤ 1.5 x ULN mg\u002FdL or creatinine clearance \\> 60 mL\u002Fmin (Within 28 days of receiving first study vaccine)\n* Patients of child-bearing potential must agree to use dual methods of contraception and have a negative urine pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a person of child-bearing potential. Acceptable methods of contraception are abstinence, condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal. Effective methods of contraception must be used throughout the study until the end of treatment on study\n\nExclusion Criteria:\n\n* Patient has received more than one line of prior therapy in metastatic setting\n* Patients with tumors that are PD-L1-positive per standard of care immunohistochemistry 22C3 pharmDx assay\n* Enrollment in a concurrent interventional clinical trial. Biomarker or tissue collection or any other non-interventional clinical trial enrollment is allowed. Participation in a trial for chimeric antigen receptor (CAR)-T cell therapy may be permitted if the CAR-T cell therapy is not planned to occur until after the currently proposed treatment (i.e. no longer participating in STEMVAC and chemotherapy trial)\n* Patients with any of the following cardiac conditions:\n\n  * Symptomatic restrictive cardiomyopathy\n  * Dilated cardiomyopathy\n  * Unstable angina within 4 months prior to enrollment\n  * New York Heart Association functional class III-IV heart failure on active treatment\n  * Symptomatic pericardial effusion\n* Patients with any autoimmune disease or comorbidities that require chronic systemic steroids or immunosuppressants. Patients with conditions requiring inhaled, intranasal or topical steroids are permitted\n* Known hypersensitivity reaction to the granulocyte-macrophage colony stimulating factor (GM-CSF) adjuvant; any known contra-indication to GM-CSF\n* A non-breast malignancy requiring radiation or systemic therapy within last 5 years or any B-cell malignancy (e.g., chronic lymphocytic leukemia or follicular lymphoma) under active surveillance\n* Pregnant and breastfeeding individuals\n* Known history of human immunodeficiency virus (HIV) infection, hepatitis B (e.g., hepatitis B virus surface antigen \\[HBsAg\\] reactive), or hepatitis C (e.g., hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] \\[qualitative\\] is detected)\n* Major surgery within the 4 weeks prior to initiation of study vaccine\n* Must be 14 days between a non-study vaccine, including live attenuated and non-live vaccines and any STEMVAC vaccination\n\n  * Note: The minimum of 14 days does not apply to the tetanus and diphtheria (Td) vaccine\n* Any condition that may interfere with the patient's participation in the study per treating physician",{"count":604,"type":21},20,[53],"This phase II trial studies how well a cancer vaccine called STEMVAC works in combination with chemotherapy in treating patients with PD-L1 negative, triple-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). STEMVAC is designed to target proteins that are expressed on breast cancer stem cells, and it is believed to work by boosting the immune system to recognize and destroy the invader tumor cells that are causing the disease. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving STEMVAC in combination with chemotherapy may be an effective treatment for PD-L1 negative metastatic triple-negative breast cancer.",[356,608],"Metastatic Triple-Negative Breast Carcinoma","2026-07-31",{"date":562,"type":34},{"date":612,"type":34},"2026-03-24",{"date":290,"type":21},{"name":40,"class":41},""]