[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cml\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cml":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,59,91,125,150],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":43,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":5},"100526212","pharmacokinetic-study-of-venetoclax-tablets-crushed-and-dissolved-into-a-solution-100526212",false,"NCT06131801","Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution","A Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution in Children and Young Adults With Hematologic Malignancies","Inclusion Criteria:\n\n* Age: Patients must be \\\u003C39 years of age at time of study enrollment\n* Diagnosis: Patients may have a diagnosis of any hematologic malignancy\n* Central access: Patients must have an existing venous or arterial access line for PK blood draws\n* Weight requirement: Patients must weigh at least 5.5 kg at the time of enrollment\n* Venetoclax: Patients must be receiving any dose of venetoclax given as a solution made from crushed tablets by mouth (PO) or via nasogastric (NG), or G-tube as prescribed by their treating oncologist.\n* Concurrent chemotherapy medications: Patients may receive venetoclax as a single agent or in combination with any other chemotherapeutic agents.\n\nExclusion Criteria:\n\n* Pregnant women are excluded from this study because venetoclax has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, breastfeeding should be discontinued if the mother is treated with venetoclax.\n* Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on study treatment and for six months following completion.","ALL","0 Years","38 Years",{"count":20,"type":21},30,"ESTIMATED","OBSERVATIONAL","The use of venetoclax-based therapies for pediatric patients with relapsed or refractory malignancies is increasingly common outside of the clinical trial setting. For patients who cannot swallow tablets, it is common to crush the tablets and dissolve them in liquid to create a solution. However, no PK data exists in adults or children using crushed tablets dissolved in liquid in this manner, and as a result, the venetoclax exposure with this solution is unknown.\n\nPrimary Objectives\n\n• To determine the pharmacokinetics of venetoclax when commercially available tablets are crushed and dissolved into a solution\n\nSecondary Objectives\n\n* To evaluate the safety of crushed venetoclax tablets administered as an oral solution\n* To determine the pharmacokinetics of venetoclax solution in patients receiving concomitant strong and moderate CYP3A inhibitors\n* To determine potential pharmacokinetic differences based on route of venetoclax solution administration (ie. PO vs NG tube vs G-tube)\n* To determine the concentration of venetoclax in cerebral spinal fluid when administered as an oral solution",[25,26,27,28,16,29,30,31,32,33,34,35,36,37,38,39,40,41,42],"Hematologic Malignancy","Leukemia","Lymphoma","Acute Lymphocytic Leukemia","Acute Myelogenous Leukemia","AML","Chronic Myelogenous Leukemia","CML","Myeloproliferative Neoplasm","Non Hodgkin Lymphoma","Hodgkin Lymphoma","Diffuse Large B Cell Lymphoma","Follicular Lymphoma","Burkitt Lymphoma","T-cell Lymphoma","B Cell Lymphoma","Peripheral T Cell Lymphoma","Cutaneous B-Cell Lymphoma",[44,45,46],"Venetoclax","Pediatric AML","Pediatric Relapsed\u002FRefractory AML","RECRUITING","2026-06-02",{"date":50,"type":51},"2026-06-04","ACTUAL",{"date":53,"type":51},"2023-11-15",{"date":55,"type":21},"2027-12-01",{"name":57,"class":58},"Children's Hospital Medical Center, Cincinnati","OTHER",{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":16,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":90},"100519771","phase-1-uab-2419-cd34-selection-using-the-automated-clinimacs-prodigy-100519771","NCT06047886","UAB 2419-CD34 Selection Using the Automated CliniMACS Prodigy","Feasibility Study of CD34 Selection for GVHD Prophylaxis Using the Automated CliniMACS","Inclusion Criteria:\n\n1. AML in morphologic remission with intermediate\u002Fhigh-risk features or relapsed disease 1 or 2\n2. ALL in morphologic remission with high-risk features or relapsed disease 1 or 2\n3. Lymphoid malignancies in CR or PR (e.g. non-Hodgkin's lymphoma, prolymphocytic leukemia, CLL)\n4. Myelodysplastic syndromes with \\\u003C=10% blasts\n5. CML in morphologic remission after blast phase or accelerated phase\n6. Primary myelofibrosis with \\\u003C=10% blasts \\^morphologic remission is defined as \\\u003C5% blasts on the bone marrow biopsy. Negative test for donor-specific antibody within 28 days of starting conditioning regimen, or adequate for standard desensitization protocol.\n\nExclusion Criteria:\n\n1. Non-compliant patients.\n2. No appropriate caregivers identified.\n3. Uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (Discretion of the attending physician).\n4. Patients with known allergy to DMSO.\n5. Pregnant or breastfeeding women","4 Weeks","75 Years",{"count":69,"type":21},50,"INTERVENTIONAL",[72],"PHASE1","Patients with graft failure or delayed engraftment may benefit from a hematopoietic stem cell boost or an additional hematopoietic stem cell transplantation procedure. In such settings standard immune suppression strategies are avoided due to their myelosuppressive nature. Therefore those patients are at increased risk of graft versus host disease, and the infusion of a CD34 selected graft would reduce such a risk. The infusion of CD34 selected graft using CliniMACS plus is currently FDA FDA-approved indication for acute myeloid leukemia. However, the use of the Prodigy would streamline the processing, in terms of hands-off procedure, allowing to provision of this product to the patients without strains on the cell therapy lab team. This procedure has been demonstrated safe and effective in several single-center studies and is currently in advanced phase investigation in several studies for malignant and non-malignant conditions.",[30,16,75,76,32,77],"Lymphoid Malignancies","Myelodysplastic Syndromes","Primary Myelofibrosis",[79,80],"hematologic malignancies","graft failure","2026-04-08",{"date":83,"type":51},"2026-04-13",{"date":85,"type":51},"2025-04-22",{"date":87,"type":21},"2029-12",{"name":89,"class":58},"University of Alabama at Birmingham",1,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":32,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":98,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":70,"phases":101,"briefSummary":102,"conditions":103,"keywords":107,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":124},"100462646","phase-1-a-phase-1a1b-study-of-elvn-001-for-the-treatment-chronic-myeloid-leukemia-100462646","NCT05304377","A Phase 1a\u002F1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia","A Phase 1a\u002F1b Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia","Inclusion Criteria:\n\n* BCR-ABL1 positive CML in chronic phase, with or without T315I mutation.\n* US: The patient has failed or is intolerant to at least one prior second-generation tyrosine kinase inhibitor (TKI) or asciminib. Rest of World: The patient has failed, is intolerant to, or not a candidate for, available therapies known to be active for treatment of their CML (country-specific criteria may vary).\n* ECOG performance status of 0 to 2.\n* Adequate hematologic, hepatic and renal function.\n* Prior bone marrow transplant allowed if ≥ 6 months prior to the first dose of ELVN-001.\n\nExclusion Criteria:\n\n* Treatment with anti-cancer or anti-CML therapy within 7 days or 5 half-lives, whichever is longer.\n* History of acute tyrosine kinase inhibitor (TKI)-related pancreatitis within 6 months of study entry. Active chronic pancreatitis, or pancreatic disease due to any cause.\n* QTc \\>470 ms.","18 Years",{"count":100,"type":21},250,[72],"The purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in patients with chronic myeloid leukemia with and without T315I mutations in patients who are relapsed, refractory or intolerant to TKIs.",[104,105,106],"Chronic Myeloid Leukemia","Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Cml",[32,108,109,110,111,112,113],"Tyrosine kinase inhibitor","T315I","T315I mutant","BCR-ABL","ENABLE","active site inhibitor of BCR-ABL","2026-03-31",{"date":116,"type":51},"2026-04-01",{"date":118,"type":51},"2022-05-22",{"date":120,"type":21},"2027-12",{"name":122,"class":123},"Enliven Therapeutics","INDUSTRY",45,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":98,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":70,"phases":136,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":90},"100548662","phase-3-study-of-olverembatinib-hqp1351-in-patients-with-cp-cml-100548662","NCT06423911","Study of Olverembatinib (HQP1351) in Patients With CP-CML","This is a Global, Multi-center, Open-label Randomized and Registrational Phase 3 Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia","POLARIS-2","Inclusion Criteria:\n\nPatients eligible for inclusion in this study must meet all of the following criteria.\n\n1. Age ≥ 18 years old.\n2. Diagnosis of CML-CP\n3. Part A: Previously treated with at least two approved TKIs Part B: T315I mutation at screening.\n4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.\n5. Written informed consent obtained prior to any screening procedures.\n6. Patients with adequate organ functions\n\nExclusion Criteria:\n\nPatients eligible for this study must not meet any of the following criteria.\n\n1. For Part A only: T315I mutation at any time prior to starting study treatment.\n2. Active infection that requires systemic drug therapy\n3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs\n4. Previous treatment with or known \u002F suspected hypersensitivity to olverembatinib or any of its excipients.\n5. Previous treatment with or known \u002F suspected hypersensitivity to bosutinib or any of its excipients.\n6. Pregnant or nursing (lactating) women.","99 Years",{"count":135,"type":21},285,[137],"PHASE3","A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)",[104,32,140],"CML, Chronic Phase","2025-05-29",{"date":143,"type":51},"2025-06-03",{"date":145,"type":51},"2024-02-05",{"date":147,"type":21},"2026-02",{"name":149,"class":123},"Ascentage Pharma Group Inc.",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":159,"conditions":160,"keywords":164,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":173,"leadSponsor":175,"locationsCount":90},"100532312","assessment-of-measurable-residual-disease-in-allo-hsct-using-digital-polymerase-chain-reaction-100532312","NCT06211166","Assessment of Measurable Residual Disease in Allo-HSCT Using Digital Polymerase Chain Reaction","Predicting Patient Relapse After Allogeneic Hematopoietic Stem Cell Transplantation: A Comparison of Measurable Residual Disease (MRD) Assessment by Digital Polymerase Chain Reaction and Conventional MRD","Inclusion Criteria:\n\n* The presence of at least one fusion gene or hematological tumor-associated mutation detected at diagnosis by NGS or real-time PCR provided for posttransplant MRD monitoring.\n* Neutrophil engraftment\n* Received at least one MRD monitoring by digital PCR after HSCT\n\nExclusion Criteria:\n\n* Patients who relapsed or died before the first digital PCR monitoring\n* Patients only with mutations in DNMT3A, TET2, and ASXL1 (\"DTA mutations\") or only germline mutations",{"count":158,"type":21},300,"A research investigation into the efficacy of digital Polymerase Chain Reaction (dPCR) for monitoring measurable residual disease (MRD) during allogeneic hematopoietic stem cell transplantation, with a focus on predicting relapse in patients diagnosed with leukemia, myelodysplastic syndromes (MDS), and related hematological conditions.",[161,162,163,32],"Acute Leukemia","MDS","MDS\u002FMPN",[165,166,167,168],"dPCR","MRD","allo-HSCT","leukemia","2024-01-08",{"date":171,"type":51},"2024-01-18",{"date":169,"type":51},{"date":174,"type":21},"2027-12-31",{"name":176,"class":58},"Peking University People's Hospital"]