[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-myeloid-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-myeloid-leukemia":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,38,0,25,[9,55,141,172,193,219,237,267,295,312,361,385,398,428,456,492,513,532,560,586,619,651,687,709,734],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100054010","phase-1-prophylactic-and-therapeutic-dli-x-for-leukemia-relapse-after-hct-100054010",false,"NCT07254793","Prophylactic and Therapeutic DLI-X for Leukemia Relapse After HCT","A Feasibility\u002FPilot First-in-human Study of Exercise-mobilized NK-enriched Donor Lymphocyte Infusions (DLI-X) to Prevent or Treat Leukemia Relapse After Allogeneic Hematopoietic Cell Transplantation","DLI Recipient Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged 0-65 years\n* Diagnosis of acute leukemia (lymphoid, myeloid or undifferentiated) myelodysplastic syndrome (MDS), chronic myeloid leukemia (CML) or non-Hodgkin's lymphoma (NHL)\n* Undergoing myeloablative or reduced intensity matched sibling donor (MSD) HCT or haploidentical HCT\n* Have a locally available healthy matched or haploidentical (≥5\u002F10 HLA antigen matched) related donor between 12 and 50 years of age, consented and able to perform the exercise sessions. (see donor inclusion criteria)\n* The familial donors will first complete the fitness evaluation to determine VO2max and peak cycling power and following successful completion of the donor evaluation, the patients willing to participate in the randomized trial will be enrolled.\n\nDLI Donor Inclusion Criteria:\n\n* Matched sibling donor or HLA-haploidentical relatives of the patient, including biological parents, siblings, or children, half-siblings, cousins or aunts and uncles\n* Weight is greater than 30 kg\n* Age 12 and 50 years\n* Ability to undergo phlebotomy\n* Cardiac, renal, pulmonary, and hepatic function within normal limits\n* Complete blood count (CBC) with differential and platelet count within normal limits, and CMP within normal limits as deemed acceptable by the Principal Investigator and provider evaluating donor.\n* The familial donors should be able complete the fitness evaluation to determine VO2max and peak cycling power and following successful completion of the donor evaluation, the patients willing to participate in the randomized trial will be enrolled.\n\nDLI Recipient Exclusion Criteria:\n\n* Acute grade III-IV aGvHD or moderate\u002Fsevere chronic GvHD.\n* Requiring immunosuppression therapy for treatment of GvHD.\n* Co-morbidities: AST\u002FALT greater than 5 x ULN; Bilirubin greater than 2 x ULN; Creatinine greater than 2 x ULN for age or creatinine clearance\u002FGFR \\\u003C40 ml\u002Fmin\u002F1.73m2; Pulmonary function: DLCO less than 40% of normal or O2 Sat less than 92%; Cardiac: left ventricular ejection fraction less than 35%; active infection; HIV positive; Karnofsky score (adults) less than 60% or Lansky score less than 50% (pediatrics)\n* Uncontrolled or severe bacterial, fungal or viral infection.\n* Positive serum or urine pregnancy test for girls post menarche or women of childbearing age.\n* Severe psychiatric illness or mental deficiency making compliance to treatment unlikely and\u002For informed consent impossible.\n* Any reason, at the investigator's discretion, that the participation of the patient in this protocol would not be in patient's best interest, or where the patient would be unable to adhere to the study requirements.\n\nDLI Donor Exclusion Criteria:\n\n* Unable to perform graded exercise test\n* Cardiac or pulmonary disease restricting exercise\n* Positive anti-donor HLA antibody\n* Pregnant or lactating\n* Active infection\n* Positivity for HIV, hepatitis B (HBV), hepatitis C (HCV), human T-cell lymphotropic virus (HTLV-I\u002FII)\n* Severe psychiatric illness or mental deficiency making compliance with donation unlikely and\u002For informed consent impossible.","ALL","65 Years",{"count":20,"type":21},94,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The primary objective of this proposal is to conduct the first-in-human randomized clinical trial evaluating prophylactic DLI-X (pro-DLI-X) for relapse prevention following matched sibling donor (MSD) or haploidentical (haplo) hematopoietic cell transplantation (HCT) in patients with hematologic malignancies. Additionally, the study aims to assess the safety and efficacy of therapeutic DLI-X (t-DLI-X) compared to t-DLI alone in patients with minimal residual disease (MRD+) or overt relapse post-alloHCT. For patients with CD19-positive lymphoid malignancies, the study will incorporate blinatumomab, while those with myeloid or CD19-negative lymphoid malignancies will receive t-DLI-X or t-DLI alone.\n\nWe hypothesize that both pro-DLI-X and t-DLI-X, with or without blinatumomab, will demonstrate safety and superior efficacy by enhancing graft-versus-leukemia (GvL) effects mediated by natural killer (NK) cells, γδ T cells, and CD8+ T cells, while maintaining manageable and treatment-responsive graft-versus-host disease (GvHD).",[27,28,29,30,31,32],"Acute Lymphoid Leukemia","Acute Myeloid Leukemia","Acute Undifferentiated Leukemia (AUL)","Myelodysplastic Syndrome","Chronic Myeloid Leukemia","Non-Hodgkin Lymphoma",[34,35,36,37,38,39,40,41],"Exercise","Donor Lymphocyte Infusion","Allogeneic Hematopoietic Stem Cell Transplantation","Hematologic Malignancies","Matched Sibling Donor","Haploidentical","Hematopoietic Cell Transplantation","DLI-X","NOT_YET_RECRUITING","2026-07-10",{"date":45,"type":46},"2026-07-13","ACTUAL",{"date":48,"type":21},"2026-10-31",{"date":50,"type":21},"2030-06-01",{"name":52,"class":53},"University of Arizona","OTHER",1,{"id":56,"slug":57,"hasResults":12,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":17,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":67,"phases":4,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100464928","collecting-blood-samples-from-patients-with-and-without-cancer-to-evaluate-tests-for-early-cancer-detection-100464928","NCT05334069","Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection","Blinded Reference Set for Multicancer Early Detection Blood Tests","Inclusion Criteria:\n\n* Participants with a cancer diagnosis: Documentation of disease:\n\n  * Histologic documentation: Histologically confirmed diagnosis of invasive cancer\n  * Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with the exception of patients with leukemia, lymphoma, and multiple myeloma\n\n    * For leukemia: Type (chronic lymphocytic leukemia \\[CLL\\], chronic myeloid leukemia \\[CML\\], acute lymphoblastic lymphoma \\[ALL\\], acute myeloid leukemia \\[AML\\])\n    * For lymphoma: Stage I-IV based on Ann Arbor staging\n    * For multiple myeloma: Stage I, II, III based on Revised International Staging System (RISS)\n  * One of the following tumor types:\n\n    * Colorectal\n    * Bladder\n    * Head and neck\n    * Hepatobiliary\n    * Lung\n    * Lymphoma\n    * Leukemia\n    * Ovary \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Pancreas \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Multiple myeloma\n    * Gastric, esophageal or gastroesophageal\n    * Breast\n    * Thyroid\n    * Kidney\n\n      * For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Endometrium\n    * Prostate\n    * Melanoma\n\n      \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Sarcoma\n* Participants with a cancer diagnosis: No prior definitive systemic or local anti-cancer intervention\n* Participants with a cancer diagnosis: Age \\>= 40 and =\\\u003C 75\n* Participants with a cancer diagnosis: No known current pregnancy by self-report\n* Participants with a cancer diagnosis: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis\n* Participants with a cancer diagnosis: Willingness to provide blood samples for research use\n* Participants with a cancer diagnosis: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a cancer diagnosis: No history of organ transplantation\n* Participants with a cancer diagnosis: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants without a cancer diagnosis and without suspicion of cancer: Age \\>= 40 and =\\\u003C 75\n* Participants without a cancer diagnosis and without suspicion of cancer: No known current pregnancy by self-report\n* Participants without a cancer diagnosis and without suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers)\n* Participants without a cancer diagnosis and without suspicion of cancer: Willingness to provide blood samples for research use\n* Participants without a cancer diagnosis and without suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants without a cancer diagnosis and without suspicion of cancer: No history of organ transplantation\n* Participants without a cancer diagnosis and without suspicion of cancer: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants with a high suspicion of cancer: High suspicion of ovarian cancer, pancreatic cancer, kidney cancer, or melanoma by clinical and\u002For radiological assessment, with plans for histologic or cytologic confirmation within 28 days after study blood draw\n\n  \\* Examples of highly suspicious cases include: elevated CA125 and abnormal transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious cutaneous lesion concerning for melanoma\n* Participants with a high suspicion of cancer: Central review of radiology reports and\u002For clinical documentation conducted by study chairs\n* Participants with a high suspicion of cancer: Age \\>= 40 and =\\\u003C 75\n* Participants with a high suspicion of cancer: No known current pregnancy by self-report\n* Participants with a high suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis\n* Participants with a high suspicion of cancer: Willingness to provide blood samples for research use\n* Participants with a high suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a high suspicion of cancer: No history or organ transplantation\n* Participants with a high suspicion of cancer: Ability to read and comprehend English or Spanish \\* Eligibility is restricted to individuals who can comprehend and read English and Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages",true,"40 Years","75 Years",{"count":66,"type":21},2000,"OBSERVATIONAL","This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.",[70,28,71,72,73,74,75,31,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129],"Acute Lymphoblastic Leukemia","Ann Arbor Stage I Lymphoma","Ann Arbor Stage II Lymphoma","Ann Arbor Stage III Lymphoma","Ann Arbor Stage IV Lymphoma","Chronic Lymphocytic Leukemia","Gastroesophageal Junction Adenocarcinoma","Head and Neck Carcinoma","Hematopoietic and Lymphoid Cell Neoplasm","Invasive Breast Carcinoma","Kidney Carcinoma","Malignant Hepatobiliary Neoplasm","Malignant Solid Neoplasm","Melanoma","Muscle-Invasive Bladder Carcinoma","RISS Stage I Plasma Cell Myeloma","RISS Stage II Plasma Cell Myeloma","RISS Stage III Plasma Cell Myeloma","Sarcoma","Stage I Bladder Cancer AJCC v6 and v7","Stage I Breast Cancer AJCC v7","Stage I Colorectal Cancer AJCC v6 and v7","Stage I Esophageal Cancer AJCC V7","Stage I Gastric Cancer AJCC V7","Stage I Lung Cancer AJCC v7","Stage I Ovarian Cancer AJCC v6 and v7","Stage I Pancreatic Cancer AJCC v6 and v7","Stage I Prostate Cancer AJCC v7","Stage I Uterine Corpus Cancer AJCC v7","Stage II Bladder Cancer AJCC v6 and v7","Stage II Breast Cancer AJCC v6 and v7","Stage II Colorectal Cancer AJCC v7","Stage II Esophageal Cancer AJCC v7","Stage II Gastric Cancer AJCC v7","Stage II Lung Cancer AJCC v7","Stage II Ovarian Cancer AJCC v6 and v7","Stage II Pancreatic Cancer AJCC v6 and v7","Stage II Prostate Cancer AJCC v7","Stage II Uterine Corpus Cancer AJCC v7","Stage III Bladder Cancer AJCC v6 and v7","Stage III Breast Cancer AJCC v7","Stage III Colorectal Cancer AJCC v7","Stage III Esophageal Cancer AJCC v7","Stage III Gastric Cancer AJCC v7","Stage III Lung Cancer AJCC v7","Stage III Ovarian Cancer AJCC v6 and v7","Stage III Pancreatic Cancer AJCC v6 and v7","Stage III Prostate Cancer AJCC v7","Stage III Uterine Corpus Cancer AJCC v7","Stage IV Bladder Cancer AJCC v7","Stage IV Breast Cancer AJCC v6 and v7","Stage IV Colorectal Cancer AJCC v7","Stage IV Esophageal Cancer AJCC v7","Stage IV Gastric Cancer AJCC v7","Stage IV Lung Cancer AJCC v7","Stage IV Ovarian Cancer AJCC v6 and v7","Stage IV Pancreatic Cancer AJCC v6 and v7","Stage IV Prostate Cancer AJCC v7","Stage IV Uterine Corpus Cancer AJCC v7","Thyroid Gland Carcinoma","RECRUITING","2026-07-01",{"date":133,"type":46},"2026-07-02",{"date":135,"type":46},"2022-08-18",{"date":137,"type":21},"2027-02-28",{"name":139,"class":53},"Alliance for Clinical Trials in Oncology",745,{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":12,"sex":17,"minAge":149,"maxAge":150,"enrollmentInfo":151,"targetDuration":4,"studyType":67,"phases":4,"briefSummary":153,"conditions":154,"keywords":155,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":4},"100645359","a-study-of-asciminib-safety-and-efficacy-in-young-adults-with-chronic-myeloid-leukemia-in-the-gulf-region-100645359","NCT07681258","A Study of Asciminib Safety and Efficacy in Young Adults With Chronic Myeloid Leukemia in the Gulf Region","ASC4Young: Real-World Study of Asciminib Safety and Efficacy in Young Adults With Chronic Myeloid Leukemia in the Gulf Region","ASC4Young","Inclusion Criteria\n\n* Confirmed diagnosis of Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP)\n* Adult patients aged ≥ 18 years at the index date (or adult as defined by applicable national regulations)\n* Documented exposure to asciminib during the identification period (May 2023 to May 2026)\n* Provision of signed informed consent for secondary use of data, or an ethics committee-approved waiver of consent, where applicable (including for deceased patients or where data were previously collected within the EHR system)\n\nExclusion Criteria\n\n* Patients who do not meet the eligibility criteria specified above\n* Patients with insufficient medical record documentation to determine asciminib exposure or key study outcomes","18 Years","99 Years",{"count":152,"type":21},80,"The aim of this study is to evaluate the real-world effectiveness and safety of asciminib among young adults with chronic myeloid leukemia (CML) across the Gulf region. The data source for this study will consist of routinely collected clinical information documented within the electronic health records (EHR) of participating centers.",[31],[156,31,157,158,159,160,161,162],"Asciminib","Young Adults","Real-world Evidence","Efficacy and Safety","Major Molecular Response","Unmet Medical Need","Gulf Region","2026-06-26",{"date":133,"type":46},{"date":166,"type":21},"2026-06-30",{"date":168,"type":21},"2027-06-30",{"name":170,"class":171},"Novartis Pharmaceuticals","INDUSTRY",{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":17,"minAge":149,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":54},"100613659","phase-2-phase-ii-study-assessing-the-safety-and-efficacy-of-dasatinib-in-combination-with-ropeginterferon-in-patients-with-newly-diagnosed-chronic-myeloid-leukemia-in-chronic-phase-100613659","NCT07269470","Phase II Study Assessing the Safety and Efficacy of Dasatinib in Combination With Ropeginterferon in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase","Inclusion Criteria:\n\nAdult patients age ≥18 years.\n\nPatients must have a diagnosis of Ph-positive or BCR::ABL1 positive CML in chronic phase.\n\nPatients who received prior hydroxyurea, 1 to 2 doses of cytarabine, and\u002For an FDA approved TKI for \\\u003C30 days are eligible.\n\nPatients with additional chromosomal abnormalities at diagnosis (early disease) and no other criteria for accelerated phase will be eligible for this study.\n\nECOG performance status ≤2.\n\nPatients must have adequate end organ function, defined as the following: total bilirubin\n\n≤1.5x ULN (unless secondary to Gilbert's disease, in which case should be ≤2.5x ULN), SGPT or SGOT ≤3x ULN, creatinine clearance ≥30mL\u002Fmin calculated using modified Cockcroft-Gault.\n\nAbility to understand and the willingness to sign a written informed consent document.\n\nDasatinib is known to be teratogenic. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n* Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n* History of hysterectomy or bilateral salpingo-oophorectomy.\n* Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n* History of bilateral tubal ligation or another surgical sterilization procedure.\n\nApproved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n\nFor patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n\nPatients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n\nHuman immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n\nPatients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\nPatients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better.\n\nExclusion Criteria:\n\nPatients who have received more than 30 days of prior FDA approved TKI or more than 2 doses of cytarabine.\n\nPatients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia.\n\nPatients who are receiving any other investigational agents.\n\nHistory of allergic reactions attributed to compounds of similar chemical or biologic composition to dasatinib, ropeginterferon, or other agents used in study.\n\nNYHA cardiac class III-IV heart disease.\n\nActive autoimmune disease at screening.\n\nHistory or presence of clinically relevant depression\n\nPatients with active, uncontrolled psychiatric disorders including psychosis, major depression, and bipolar disorders.\n\nPatients with cognitive impairment or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n\nEvidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n1. Uncontrolled and\u002For active systemic infection (viral, bacterial or fungal)\n2. Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment and having detectable virus load. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface antigen negative, anti-HBs antibody positive and antihepatitis B core antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins may participate.\n\nAny contraindications or hypersensitivity to dasatinib or IFN-α and\u002For its excipients\n\nPatients in accelerated (except as noted in inclusion criteria 4.1) or blast phase are excluded.\n\nPregnant women are excluded from this study because dasatinib is an agent with 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 dasatinib, breastfeeding should be discontinued if the mother is treated with dasatinib. These potential risks may also apply to other agents used in this study.",{"count":179,"type":21},40,[181],"PHASE2","The goal of this clinical research study is to find out if treatment with a combination of dasatinib plus ropeginterferon can help to control CML-CP. The safety of this combination will also be studied.",[31],"2026-06-09",{"date":186,"type":46},"2026-06-11",{"date":188,"type":21},"2026-11-01",{"date":190,"type":21},"2029-11-01",{"name":192,"class":53},"M.D. Anderson Cancer Center",{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":17,"minAge":149,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":67,"phases":4,"briefSummary":203,"conditions":204,"keywords":206,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":4},"100642928","efficacy-of-asciminib-in-real-world-in-patients-with-chronic-myeloid-leukemia-in-second-or-subsequent-lines-100642928","NCT07640750","Efficacy of Asciminib in Real-world in Patients With Chronic Myeloid Leukemia in Second or Subsequent Lines","Retrospective and Prospective Observational Study on the Efficacy and Tolerability of Asciminib in Real-world Clinical Practice in Patients With Chronic Myeloid Leukemia Treated in Second or Subsequent Lines: ASCIRLI (ASCIminib in Real-Life Italy)","ASCIRLI","Inclusion Criteria:\n\n1. Patients aged ≥ 18 years and no upper age limit;\n2. Patients with a diagnosis of CML-CP who started treatment with asciminib according to clinical practice - from the date of commercial availability of asciminib - until the end of recruitment period (two years after the first patient included);\n3. Patients treated with asciminib in second or subsequent lines of therapy (≥2L)\n4. Patients who provide written informed consent to participate in the study (if applicable).\n\nExclusion Criteria:\n\n* None",{"count":202,"type":21},98,"The goal of this observational study is to evaluate the efficacy and tolerability of asciminib in real-life in patients with chronic myeloid leukemia treated in second or subsequent lines. The main object of the study is to assess the achievement of Major Molecular Response.",[31,205],"Chronic Myeloid Leukemia - Chronic Phase",[207,208,209,210],"chronic myeloid leukemia","asciminib","real-life","second line","2026-06-08",{"date":186,"type":46},{"date":214,"type":21},"2026-09-01",{"date":216,"type":21},"2031-12-01",{"name":218,"class":53},"Gruppo Italiano Malattie EMatologiche dell'Adulto",{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":17,"minAge":149,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":22,"phases":227,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":54},"100534276","phase-2-phase-ii-study-assessing-efficacy-and-safety-of-asciminib-in-patients-with-newly-diagnosed-chronic-myeloid-leukemia-in-chronic-phase-100534276","NCT06236724","Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.","Inclusion Criteria:\n\n* Adult participants age ≥18 years.\n* Participants must have a diagnosis of Ph-positive or BCR::ABL1 positive CML in early chronic phase (i.e., time from diagnosis ≤12 months).\n* Participants who received prior hydroxyurea, 1 to 2 doses of cytarabine, and\u002For an FDA approved TKI for \\\u003C30 days are eligible.\n* Participants with additional chromosomal abnormalities at diagnosis (early disease) and no other criteria for accelerated phase will be eligible for this study.\n* ECOG performance status ≤2.\n* Participants must have adequate end organ function, defined as the following: total bilirubin ≤1.5x ULN (unless secondary to Gilbert's disease, in which case should be ≤2.5x ULN), SGPT or SGOT ≤3x ULN, creatinine clearance ≥30mL\u002Fmin calculated using modified Cockcroft-Gault.\n* Ability to understand and the willingness to sign a written informed consent document.\n* The effects of asciminib on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n\n  * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n  * History of hysterectomy or bilateral salpingo-oophorectomy.\n  * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n  * History of bilateral tubal ligation or another surgical sterilization procedure.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Participants\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of asciminib administration.\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n\nExclusion Criteria:\n\n* Participants who have received more than 30 days of prior FDA approved TKI or more than 2 doses of cytarabine.\n* Had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia.\n* Participants who are receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to asciminib or other agents used in study.\n* NYHA cardiac class 3-4 heart disease\n* Cardiac Symptoms: Participants meeting the following criteria are not eligible unless cleared by Cardiology:\n\n  * Uncontrolled angina within 3 months\n  * Diagnosed or suspected congenital long QT syndrome\n  * Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes).\n  * Prolonged QTc interval on pre-entry electrocardiogram (\\> 460 msec)\n* History of significant bleeding disorder unrelated to cancer, including unless cleared by hematologist or hemato-oncologist:\n\n  * Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)\n  * Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)\n* Participants with active, uncontrolled psychiatric disorders including psychosis, major depression, and bipolar disorders.\n* Participants with cognitive impairment or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n  * Uncontrolled and\u002For active systemic infection (viral, bacterial or fungal)\n  * Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment and having detectable virus load. Note: participants with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface antigen negative, anti-HBs antibody positive and anti-hepatitis B core antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins may participate.\n* Pregnant women are excluded from this study because asciminib is a BCR::ABL1 TKI with 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 asciminib, breastfeeding should be discontinued if the mother is treated with asciminib. These potential risks may also apply to other agents used in this study.\n* Participants in late chronic phase (i.e., time from diagnosis to treatment \\>12 months), accelerated (except as noted in inclusion criteria 4.1) or blast phase are excluded. The definitions of CML phases are as follows:\n\n  * Early chronic phase: time from diagnosis to therapy ≤12 months Late chronic phase: time from diagnosis to therapy \\>12 months\n  * Blastic phase: presence of 30% blasts or more in the peripheral blood or bone marrow\n  * Accelerated phase CML: presence of any of the following features:\n\n    i. Peripheral or marrow blasts 15% or more ii. Peripheral or marrow basophils 20% or more iii. Thrombocytopenia \\\u003C100 x 109\u002FL unrelated to therapy iv. Documented extramedullary blastic disease outside liver or spleen.",{"count":226,"type":21},50,[181],"To learn if asciminib can help to control CML. The safety and effects of this drug will also be studied.",[31],"2026-06-04",{"date":211,"type":46},{"date":233,"type":46},"2024-01-31",{"date":235,"type":21},"2035-07-01",{"name":192,"class":53},{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":17,"minAge":243,"maxAge":244,"enrollmentInfo":245,"targetDuration":4,"studyType":22,"phases":247,"briefSummary":248,"conditions":249,"keywords":254,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":54},"100500742","phase-2-alphabeta-t-cell-and-cd19-b-cell-depletion-in-allogeneic-stem-cell-transplantation-in-patients-with-malignant-diseases-100500742","NCT05800210","Alpha\u002FBeta T Cell and CD19+ B Cell Depletion in Allogeneic Stem Cell Transplantation in Patients With Malignant Diseases","Inclusion Criteria:\n\nA. Children, Adolescents, Young adults (ages 6 months to ≤39 years) with the following diseases may be eligible:\n\ni. ALL\n\n1. ALL high risk including one or more of the following: (t(9;22) or 11q23 chromosomal abnormality, primary induction failure (≤15% blasts at time of registration), mixed phenotype acute leukemia (MPAL), persistent MRD (≥0.01% by flow or persistent abnormal karyotype detected by cytogenetics) or hypodiploidy (≤44 chromosomes)) in first remission\n2. ALL in second remission and beyond\n\nii. AML\n\n1. History of AML induction\u002Freinduction Failure (≤15% blasts at time of registration)\n2. AML in CR1 with poor cytogenetics (i.e., 12p, 5a, -7, FLT3 mutation\u002Fduplication, t(9;11) and others)\n3. AML with persistent minimal residual disease (MRD) in CR1(≥0.01% on flow or persistent abnormal karyotype detected by cytogenetics)\n4. AML CR2 or beyond\n5. AML in refractory relapse but ≤15% bone marrow leukemia blasts\n6. Therapy-related AML\n\niii. Juvenile MyeloMonocytic Leukemia (JMML)\n\n1. JMML in CR1 without CBL mutation\n2. JMML with recurrence of disease with or without CBL mutation\n3. JMML CR2 or beyond\n\niv. Chronic Myeloid Leukemia (CML)\n\n1\\. CML in CR with regard to blast crisis\n\nv. High Risk Myelodysplastic syndrome (MDS)\n\nvi. Lymphoma: Hodgkin (HL) or Non-Hodgkin (NHL)\n\n1. HL or NHL with a history of induction failure\n2. HL or NHL in PR1 or PR2\n3. HL or NHL in CR2 or subsequent remission\n\nB. Subjects must not have more than one active malignancy at the time of enrollment (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \\[as determined by the treating physician and approved by the PI\\] may be included).\n\nC. HLA-matched (5-6\u002F6) sibling donor, matched (8-10\u002F10) unrelated donor available for stem cell donation, haplo-identical related donor (at least one full haplotype must be matched).\n\nD. Karnofsky or Lansky score ≥60% at the time of enrollment. Karnofsky scores must be used for patients \\>16 years of age and Lansky scores for patients ≤16 years of age.\n\nE. Adequate organ function (within 4 weeks of initiation of preparative regimen), defined as:\n\ni. Pulmonary: FEV1, FVC, and corrected DLCO must all be ≥ 60% of predicted by pulmonary function tests (PFTs). For children who are unable to perform for PFTs due to age, the criteria are: no evidence of dyspnea at rest and no need for supplemental oxygen.\n\nii. Renal: Creatinine clearance or radioisotope GFR ≥60 mL\u002Fmin\u002F1.73 m2 or a serum creatinine based on age\u002Fgender\n\niii. Cardiac: Shortening fraction of ≥ 27% by echocardiogram) or ejection fraction of ≥ 50% by echocardiogram or radionuclide scan (MUGA).\n\niv. Hepatic: SGOT (AST) or SGPT (ALT) \\\u003C 5 x upper limit of normal (ULN) for age. Conjugated bilirubin \\\u003C 2.5 mg\u002FdL, unless attributable to Gilbert's Syndrome.\n\nF. Written informed consent obtained from the subject or guardian and the subject agrees to comply with all the study-related procedures.\n\nG. Subjects of childbearing potential (SOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 8 weeks after the last dose of study drug to minimize the risk of pregnancy.\n\nH. Subjects with partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 8 weeks following the last dose of study drug.\n\nExclusion Criteria:\n\nA. Patients with documented uncontrolled infection\n\nB. Patients who have received allogeneic hematopoietic stem cell transplantation within 6 months, unless being done as a boost.\n\nC. Patients with active ≥Grade 2 aGVHD.\n\nD. Demonstrated lack of compliance with medical care.\n\nE. Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 8 weeks after the last dose of study drug.\n\nF. Females who are known to be pregnant or breastfeeding.\n\nG. History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.\n\nH. Prisoners or subjects who are incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.","6 Months","39 Years",{"count":246,"type":21},20,[181],"This study will assess the safety, efficacy, and feasibility of ⍺\u002Fβ CD3+ T-cell and CD19+ B-cell depletion in allogeneic stem cell transplantation in patients with acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), juvenile myelomonocytic leukemia (JMML), high risk myelodysplastic syndrome (MDS), chronic myeloid leukemia (CML) and lymphoma. Subjects will receive an allogeneic stem cell transplant that has been depleted of ⍺\u002Fβ CD3+ T-cells and CD19+ B-cells using the Miltenyi CliniMACS Prodigy® system.",[70,28,250,251,31,252,253],"Juvenile Myelomonocytic Leukemia","Myelodysplastic Syndromes","Lymphoma, Non-Hodgkin","Lymphoma, Hodgkin",[255,256,257,258],"hematologic malignancy","GVHD","stem cell transplantation","graft manipulation","2026-06-02",{"date":230,"type":46},{"date":262,"type":46},"2024-05-03",{"date":264,"type":21},"2028-05",{"name":266,"class":53},"University of Florida",{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":17,"minAge":149,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":22,"phases":276,"briefSummary":277,"conditions":278,"keywords":4,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":294},"100467132","phase-1-a-study-of-mgd024-in-patients-with-relapsed-or-refractory-hematologic-malignancies-100467132","NCT05362773","A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies","A Phase 1, First-in-Human, Dose Escalation Study of MGD024, a CD123 x CD3 Bispecific DART Molecule, in Patients With Select Relapsed or Refractory Hematologic Malignancies","Inclusion Criteria:\n\n* Adult patients at least 18 years of age, able to provide informed consent and willing to comply with all study procedures.\n* Participants with\n\n  * primary or secondary acute myeloid leukemia (AML) except acute promyelocytic leukemia,\n  * primary or secondary myelodysplastic syndrome (MDS) with prognostic score of \\>3 and \\\u003C20% bone marrow blasts,\n  * classical Hodgkin lymphoma (cHL),\n  * chronic myelogenous leukemia (CML),\n  * b-cell acute lymphocytic leukemia (B-ALL),\n  * hariy cell leukemia (HCL),\n  * advanced systemic mastocytosis (ASM), or\n  * blastic plasmacytoid dendritic cell neoplasm (BPDCM)\n* Relapsed after or refractory to at least one prior line of therapy and with no available potentially curative treatment option.\n* Evidence of at least 20% of malignant cells with CD123 expression.\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.\n* Life expectancy of at least 12 weeks.\n* Acceptable laboratory values, and heart function.\n* Continuing side effects of prior treatment are mild\n* Women and men of childbearing potential must agree to use highly effective forms of contraception throughout the study through 4 months after the last dose of MGD024.\n\nExclusion Criteria:\n\n* Prior treatment with an anti-CD123-directed agent (except patients with BPDCN, who are allowed to have received prior tagraxofusp).\n* Known involvement of central nervous system (CNS) by the disease under investigation.\n* 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.\n* Systemic anti-cancer therapy, investigational therapy, corticosteroids or other immune suppressive drugs within 14 days of first dose\n* Vaccination with any live virus vaccine within 4 weeks prior to first dose. Inactivated annual influenza and SARS-CoV-2 vaccination are allowed.",{"count":275,"type":21},130,[24],"CP-MGD024-01 is a Phase 1, open-label, multi-center study of MGD024 as a single agent in participants with select blood cancers that have not responded to treatment with standard therapies or who have relapsed after treatment. The study is designed to determine the safety, tolerability, pharmacokinetics (affect of the body on the drug), pharmacodynamic (affect of the drug on the body), immunogenicity (development of antibodies against the drug), and preliminary anti-cancer effect of MGD024.\n\nParticipants will receive treatment with MGD024 in consecutive 28-day cycles for a study treatment period of up to 12 cycles (approximately 1 year) or until treatment or study discontinuation criteria are met. Response assessments will be performed after Cycle 1 and then after every even numbered cycle starting with Cycle 2 until progression or study treatment discontinuation. Participants will be checked for side effects throughout the study.",[279,251,280,281,282,283,284,31],"Leukemia, Acute Myeloid","Classical Hodgkin Lymphoma","Leukemia, B-cell","Leukemia, Hairy Cell","Mastocytosis, Aggressive Systemic","Blastic Plasmacytoid Dendritic Cell Neoplasm","2026-05-20",{"date":287,"type":46},"2026-05-22",{"date":289,"type":46},"2022-07-13",{"date":291,"type":21},"2027-05",{"name":293,"class":171},"MacroGenics",7,{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":17,"minAge":149,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":22,"phases":302,"briefSummary":303,"conditions":304,"keywords":4,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":54},"100578932","phase-2-phase-ii-study-assessing-the-efficacy-and-toxicity-of-olverembatinib-monotherapy-in-patients-with-newly-diagnosed-chronic-myeloid-leukemia-in-chronic-phase-100578932","NCT06817720","Phase II Study Assessing the Efficacy and Toxicity of Olverembatinib Monotherapy in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase","Eligibility Criteria:\n\n* Adult participants age ≥18 years.\n* Participants must have a diagnosis of Ph-positive or BCR::ABL1 positive CML in early chronic phase.\n* Participants who received prior hydroxyurea, 1 to 2 doses of cytarabine, and\u002For an FDA approved TKI for ≤ 30 days are eligible.\n* Participants with additional chromosomal abnormalities at diagnosis (early disease) and no other criteria for accelerated phase will be eligible for this study.\n* ECOG performance status ≤ 2.\n* Participants must have adequate end organ function, defined as the following: total bilirubin ≤1.5x ULN (unless secondary to Gilbert's disease, in which case should be ≤ 2.5x ULN), SGPT or SGOT ≤ 3x ULN, creatinine clearance ≥ 30mL\u002Fmin calculated using modified Cockcroft-Gault.\n* Ability to understand and the willingness to sign a written informed consent document.\n* The effects of olverembatinib on the developing human fetus are unknown. For this reason,women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 4 months after completion of olverembatinib administration. This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participants presents with an applicable exclusionary factor which may be one of the following:\n\n  * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n  * History of hysterectomy or bilateral salpingo-oophorectomy.\n  * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n  * History of bilateral tubal ligation or another surgical sterilization procedure.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Participant post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n\n  * Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of olverembatinib administration.\n  * For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n  * Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured.\n\nFor participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n\n* Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2 or better.\n\nExclusion Criteria:\n\n* Participants who have received more than 30 days of prior FDA approved TKI or more than 2 doses of cytarabine.\n* Had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy with the exception of alopecia.\n* Participants who are receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to olverembatinib or other agents used in study.\n* NYHA cardiac class 3-4 heart disease\n* Cardiac Symptoms: Participants meeting the following criteria are not eligible unless cleared by cardiologist\n\n  * Uncontrolled angina within 3 months\n  * Diagnosed or suspected congenital long QT syndrome\n  * Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes).\n  * Prolonged QTc interval on pre-entry electrocardiogram (\\> 460 msec)\n* History of significant bleeding disorder unrelated to cancer, including unless cleared by hematologist or hemato-oncologist:\n\n  * Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)\n  * Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)\n\n    * Participants with active, uncontrolled psychiatric disorders including psychosis, major depression, and bipolar disorders.\n    * Participants with cognitive impairment or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n    * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n    * Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n  * Uncontrolled and\u002For active systemic infection (viral, bacterial or fungal)\n  * Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment and having detectable virus load. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface antigen negative, anti-HBs antibody positive and antihepatitis B core antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins may participate.\n\n    * Pregnant women are excluded from this study because olverembatinib is a BCR::ABL1 TKI with 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 olverembatinib, breastfeeding should be discontinued if the mother is treated with olverembatinib. These potential risks may also apply to other agents used in this study.\n    * Participants in late chronic phase (i.e., time from diagnosis to treatment \\> 12 months), accelerated (except as noted in inclusion criteria 4.1) or blast phase are excluded. The definitions of CML phases are as follows:\n  * Early chronic phase: time from diagnosis to therapy ≤ 12 months.\n  * Late chronic phase: time from diagnosis to therapy \\> 12 months.\n  * Blastic phase: presence of 30% blasts or more in the peripheral blood or bone marrow.\n  * Accelerated phase CML: presence of any of the following features:\n\n    i. Peripheral or marrow blasts 15% or more. ii. Peripheral or marrow basophils 20% or more. iii. Thrombocytopenia \\\u003C 100 x 109\u002FL unrelated to therapy. iv. Documented extramedullary blastic disease outside liver or spleen.",{"count":226,"type":21},[181],"To learn if olverembatinib can help to control newly diagnosed CML in the chronic phase.",[31],"2026-05-18",{"date":285,"type":46},{"date":308,"type":46},"2025-10-13",{"date":310,"type":21},"2027-03-07",{"name":192,"class":53},{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":319,"enrollmentInfo":320,"targetDuration":4,"studyType":22,"phases":322,"briefSummary":323,"conditions":324,"keywords":349,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":54},"100310864","phase-1-ha-1-t-tcr-t-cell-immunotherapy-for-the-treatment-of-patients-with-relapsed-or-refractory-acute-leukemia-after-donor-stem-cell-transplant-100310864","NCT03326921","HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant","Phase I Study of Adoptive Immunotherapy With CD8+ and CD4+ Memory T Cells Transduced to Express an HA-1-Specific T Cell Receptor (TCR) for Children and Adults With Recurrent Acute Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation (HCT)","Inclusion Criteria:\n\n* Subject age 0-80 years at the time of enrollment.\n* Subject must express HLA-A\\*0201\n* Subject must have the HA-1(H) genotype (RS\\_1801284: A\u002FG, A\u002FA)\n* Subject must have an adult donor for HCT who is adequately HLA matched by institutional standards (includes HLA-matched related or unrelated donors, and HLA-mismatched family donors, including haploidentical donors) and is either:\n\n  * HLA-A\\*0201 positive and HA-1(H) negative (RS\\_1801284: G\u002FG) or\n  * HLA-A\\*0201 negative\n* Subjects who are currently undergoing or who previously underwent allogeneic HCT for\n\n  * Acute myeloid leukemia (AML) of any subtype\n  * Acute lymphoid leukemia (ALL) of any subtype\n  * Mixed phenotype\u002Fundifferentiated\u002Fany other type of acute leukemia, including blastic plasmacytoid dendritic cell neoplasm\n  * Chronic myeloid leukemia with a history of blast crisis and:\n\n    * With relapse or refractory disease (\\>= 5% marrow blasts, or circulating blasts) at any time after HCT\n    * With persistent rising minimal residual disease (defined as detectable disease by morphology, flow cytometry, molecular or cytogenetic testing but \\\u003C 5% marrow blasts by morphology, no circulating blasts on \\>= 2 of two consecutive tests), refractory or ineligible for treatment with tyrosine kinase inhibitors at any time after HCT\n  * Myelodysplastic syndrome (MDS) of any subtype\n  * Chronic myelomonocytic leukemia (CMML)\n  * Juvenile myelomonocytic leukemia (JMML)\n* Subjects must be able to understand and be willing to give informed consent; decision-impaired adults may consent with their legally authorized representative; parent or legal representative will be asked to consent for subjects younger than 18 years old\n* Subjects must agree to participate in long-term follow-up for up to 15 years if they are enrolled in the study and receive T cell infusion\n* Subjects who have relapsed or have MRD after HCT may receive other agents for treatment of disease and remain eligible for the protocol\n* A specific performance status score is not required for enrolling on the protocol; a delay in infusion of the HA-1 TCR T cells may be required for subjects with low performance status\n\nDONOR SELECTION INCLUSION\n\n* Donor age \\>= 18 years\n* Donors must be able to give informed consent\n\nExclusion Criteria:\n\n* Medical or psychological conditions that would make the subject unsuitable candidate for cell therapy at the discretion of the principal investigator (PI)\n* Fertile subjects unwilling to use contraception during and for 12 months after treatment\n* Subjects with a life expectancy of \\\u003C 3 months of enrollment from coexisting disease other than leukemia\n* Subjects who have ongoing grade IV acute GVHD or severe chronic GVHD following most recent transplant. Exception: the principal investigator (PI) may make an exception on a case-by-case basis to include such a subject if there is doubt surrounding the GVHD diagnosis and\u002For sustained significant improvement in GVHD severity\n* The presence of organ toxicities will not necessarily exclude subjects from enrolling on the protocol at the discretion of the PI; however, a delay in the infusion of HA-1 TCR T cells may be required\n\nDONOR SELECTION EXCLUSION\n\n* Donors who are human immunodeficiency virus (HIV)-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2 seropositive or with active hepatitis B or hepatitis C virus infection\n* Unrelated donor residing outside of the United States of America (USA) unless the donor screening, testing and leukapheresis occur at an National Marrow Donor Program (NMDP)-affiliated and qualified donor center and are facilitated by the NMDP","80 Years",{"count":321,"type":21},24,[24],"This phase I trial studies the side effects and best dose of CD4+ and CD8+ HA-1 T cell receptor (TCR) (HA-1 T TCR) T cells in treating patients with acute leukemia that persists, has come back (recurrent) or does not respond to treatment (refractory) following donor stem cell transplant. T cell receptor is a special protein on T cells that helps them recognize proteins on other cells including leukemia. HA-1 is a protein that is present on the surface of some peoples' blood cells, including leukemia. HA-1 T cell immunotherapy enables genes to be added to the donor cells to make them recognize HA-1 markers on leukemia cells.",[250,325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340,341,30,28,70,342,31,343,344,345,346,347,348],"Recurrent Acute Biphenotypic Leukemia","Recurrent Acute Undifferentiated Leukemia","Recurrent Childhood Acute Lymphoblastic Leukemia","Recurrent Childhood Acute Myeloid Leukemia","Refractory Acute Lymphoblastic Leukemia","Refractory Adult Acute Lymphoblastic Leukemia","Blast Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm","Recurrent Myelodysplastic Syndrome","Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm","Refractory Myelodysplastic Syndrome","Acute Undifferentiated Leukemia","Mixed Phenotype Acute Leukemia","Recurrent Chronic Myeloid Leukemia, BCR-ABL1 Positive","Refractory Chronic Myeloid Leukemia, BCR-ABL1 Positive","Recurrent Acute Lymphoblastic Leukemia","Recurrent Acute Myeloid Leukemia","Acute Biphenotypic Leukemia","Chronic Myelomonocytic Leukemia","Minimal Residual Disease","Recurrent Chronic Myelomonocytic Leukemia","Recurrent Mixed Phenotype Acute Leukemia","Leukemia","Chronic Myeloid Leukemia, BCR-ABL1 Positive",[350,351,352,347],"HA-1","TCR","Immunotherapy","2026-05-15",{"date":305,"type":46},{"date":356,"type":46},"2018-02-23",{"date":358,"type":21},"2028-07-16",{"name":360,"class":53},"Fred Hutchinson Cancer Center",{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":17,"minAge":149,"maxAge":368,"enrollmentInfo":369,"targetDuration":4,"studyType":67,"phases":4,"briefSummary":371,"conditions":372,"keywords":373,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":384},"100511752","asciminib-rmp-study-100511752","NCT05943522","Asciminib RMP Study","A Post Approval Surveillance of Scemblix® (Asciminib) in Patients With Chronic Myeloid Leukemia (CML) in Korea","Inclusion criteria\n\n1. Adult patients diagnosed with Ph+ CP-CML and currently receiving or going to receive Scemblix® treatment according to locally approval label\n2. Patients who are willing to provide written informed consent prior to study enrollment\n\nExclusion criteria\n\n1. Patients with contraindication according to locally approved label of Scemblix®\n2. Patients who receive or are going to receive any investigational medicine during the observation period","100 Years",{"count":370,"type":21},600,"This study is a prospective, open-label, multi-center, non-comparative, observational study to assess safety and effectiveness of Asciminib in the real-world clinical setting in Korean Chronic myeloid leukemia (CML) patients.",[31],[374,156,375,31],"Scemblix","CML","2026-04-17",{"date":378,"type":46},"2026-04-20",{"date":380,"type":46},"2023-07-19",{"date":382,"type":21},"2030-06-07",{"name":170,"class":171},17,{"id":386,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":387,"targetDuration":4,"studyType":22,"phases":388,"briefSummary":25,"conditions":389,"keywords":390,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":397,"locationsCount":54},"100612531",{"count":20,"type":21},[24],[27,28,29,30,31,32],[34,35,36,37,38,39,40,41],"2026-04-01",{"date":393,"type":46},"2026-04-07",{"date":395,"type":21},"2026-05-31",{"date":50,"type":21},{"name":52,"class":53},{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":375,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":17,"minAge":149,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":22,"phases":407,"briefSummary":408,"conditions":409,"keywords":412,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":427},"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.",{"count":406,"type":21},250,[24],"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.",[31,410,411],"Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Cml",[375,413,414,415,416,417,418],"Tyrosine kinase inhibitor","T315I","T315I mutant","BCR-ABL","ENABLE","active site inhibitor of BCR-ABL","2026-03-31",{"date":391,"type":46},{"date":422,"type":46},"2022-05-22",{"date":424,"type":21},"2027-12",{"name":426,"class":171},"Enliven Therapeutics",45,{"id":429,"slug":430,"hasResults":12,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":4,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":17,"minAge":149,"maxAge":18,"enrollmentInfo":435,"targetDuration":4,"studyType":22,"phases":436,"briefSummary":437,"conditions":438,"keywords":439,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":455},"100326728","phase-1-expandedactivated-gamma-delta-t-cell-infusion-following-hematopoietic-stem-cell-transplantation-and-post-transplant-cyclophosphamide-100326728","NCT03533816","Expanded\u002FActivated Gamma Delta T-cell Infusion Following Hematopoietic Stem Cell Transplantation and Post-transplant Cyclophosphamide","Phase I Study of Ex Vivo Expanded\u002FActivated Gamma Delta T-cell Infusion Following Haploidentical Hematopoietic Stem Cell Transplantation and Post-transplant Cyclophosphamide","Inclusion Criteria:\n\nThe following criteria are used to enroll patients in the study before transplant.\n\n* Patients with neoplastic hematological disorders with indication of allogeneic transplant according to the National Comprehensive Cancer Network (NCCN) or other standard guidelines as follows:\n\n  * Acute myeloid leukemia \\[AML\\] in morphologic complete remission with intermediate\u002Fhigh-risk features (per NCCN criteria) or relapsed disease\n  * Chronic myeloid leukemia \\[CML\\] in any chronic phase.\n  * Myelodysplastic syndrome \\[MDS\\] with intermediate\u002Fhigh risk features or refractory disease (with bone marrow blast count \\\u003C10%).\n  * Acute lymphoblastic leukemia \\[ALL\\] in morphologic complete remission with high-risk features or relapsed disease.\n* Negative test for donor-specific antibody within 28 days of starting conditioning regimen.\n* Age Criteria: 19-65 years.\n* Organ Function Criteria: The following organ function testing should be done within 35 days before study registration.\n\n  * Cardiac: Normal left ventricular ejection fraction (LVEF) (50% or above) as measured by MUGA or Echocardiogram.\n  * Pulmonary: FVC, FEV1 and DLCO (corrected) should be 50% or above of expected.\n  * Renal: serum creatinine level to be \\\u003C2 mg\u002Fdl AND estimated (Cockcroft-Gault formula) or measured (takes priority if done) creatinine clearance (CrCl) must be equal or greater than 70 mL\u002Fmin\u002F1.73 m2.\n  * Hepatic: serum bilirubin 1.5 upper limit of normal (ULN), Aspartate transaminase (AST)\u002Falanine transaminase (ALT) 2.5 ULN, and alkaline phosphatase 2.5 ULN.\n* Performance status: Karnofsky performance score (KPS) or Lansky score: ≥80.\n* Hematopoietic cell transplant comorbidity index (HCT-CI) \\\u003C3. Exception may be made on individual cases after discussion with the primary investigator.\n* Consent: All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.\n\nThe following criteria are required within 48 hours prior to infusion of the EAGD T cell product.\n\n* Absence of uncontrolled infection with sepsis syndrome (e.g persistent positive blood culture).\n* NO hemodynamic instability (due to sepsis or organ dysfunction) or circulatory volume overload.\n* NO clinically significant organ toxicity that are defined as follows:\n\n  * Heart failure with subnormal LVEF or clinical fluid overload.\n  * Elevated serum creatinine or subnormal creatinine clearance (either estimated or measured).\n  * Elevated total bilirubin ≥1.5 upper normal level (unless indirect hyperbilirubinemia attributed to non-hepatic pathology), or elevated liver enzymes (ALT, AST, ALP) \\>5 x ULN.\n  * Hypoxemia requiring oxygen therapy\n* NO acute graft versus host disease (any grade).\n* Neutrophil engraftment.\n\nExclusion Criteria:\n\n* Non-compliant patients.\n* No appropriate caregivers identified.\n* Uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (Discretion of the attending physician).\n* Active central nervous system (CNS) neoplastic involvement.\n* Morbid obesity with body mass index \\>35 (borderline cases may be considered on case-by-case basis after discussion with the primary investigator).\n* Patients with known allergy to DMSO.\n* HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive.\n* Pregnant or breastfeeding women.",{"count":5,"type":21},[24],"Gamma delta T-cells are part of the innate immune system with the ability to recognize malignant cells and kill them. This study uses gamma delta T-cells to maximize the anti-tumor response and minimize graft versus host disease (GVHD) in leukemic and myelodysplastic patients who have had a partially mismatched bone marrow transplant (haploidentical).",[28,31,70,251],[440,441,442,443,444,445],"Gamma delta T-cells","Hematopoietic Stem Cell Transplantation (HCT)","Post-transplant Cyclophosphamide (PTCy)","Expanded\u002FActivated gamma delta (EAGD)","Graft versus host disease (GVHD)","haploidentical","2026-03-20",{"date":448,"type":46},"2026-03-25",{"date":450,"type":46},"2020-01-31",{"date":452,"type":21},"2028-01",{"name":454,"class":53},"University of Kansas Medical Center",2,{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":17,"minAge":464,"maxAge":4,"enrollmentInfo":465,"targetDuration":4,"studyType":22,"phases":467,"briefSummary":468,"conditions":469,"keywords":473,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":491},"100592534","phase-1-a-study-of-cbx-250-in-participants-with-relapsed-or-refractory-myeloid-leukemias-100592534","NCT06994676","A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias","CROSSCHECK-001: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate Safety, Tolerability, and Clinical Activity of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias","CROSSCHECK-001","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\nAge\n\n1. Dose Escalation: Male or female participants aged ≥18 years.\n2. Backfill Cohorts: Male or female participants aged ≥12 years for whom no curative treatment options, including transplantation, are available.\n\n   Diagnosis \\& Disease Characteristics\n3. Participants with histological confirmation of advanced hematologic malignancy including:\n\n   1. R\u002FR AML, as defined by standardized criteria (e.g., European LeukemiaNet criteria \\[Dohner 2022\\]; after standard of care therapy. Participants with persistent leukemia after initial therapy or with recurrence of leukemia at any time after achieving a response during or after the course of treatment (including HSCT) are eligible.\n   2. R\u002FR HR-MDS or very high risk MDS as per the Revised International Prognostic Scoring System (IPSS-R; Greenberg 2012) or Molecular International Prognostic Scoring System (IPPS-M, Bernard 2022) who are resistant or refractory to 4-6 cycles of hypomethylating agents (HMA; decitabine or azacitidine).\n   3. R\u002FR CMML who are resistant or refractory to 4-6 cycles of hypomethylating agents (HMA; decitabine or azacitidine).\n4. White blood cells must be below 25,000\u002FµL at time of enrollment. Participants may receive cytoreduction prior to enrollment.\n5. Historical documented evidence of HLA-A\\*02:01 allele positivity.\n\n   Performance Level\n6. ECOG PS score 0-1 (if aged ≥18 years); Karnofsky Performance Scale of ≥70 (if aged ≥16 years and \\\u003C18 years); Lansky PS of ≥70 (if aged \\\u003C16 years).\n\n   Prior Therapy\n7. Any prior treatment-related toxicities resolved to ≤Grade 1 prior to enrollment, with the exception of ≤Grade 2 alopecia.\n8. Radiation Therapy: At least 60 days from prior total body irradiation, craniospinal radiation and\u002For ≥50% radiation of the pelvis, or at least 14 days from local palliative radiation therapy (small port).\n9. Stem Cell Infusion: At least 60 days must have elapsed from HSCT and at least 4 weeks (from first dose) must have elapsed from donor lymphocyte infusion without conditioning.\n10. Immunotherapy: At least 42 days since prior immunotherapy, including tumor vaccines and checkpoint inhibitors, and at least 21 days since receipt of chimeric antigen receptor therapy.\n11. Anti-Leukemia Therapy: At least 14 days since the completion of anti-leukemic therapy (for example, but not limited to, small molecule or cytotoxic\u002Fmyelosuppressive therapy), with the following exceptions:\n\n    * Hydroxyurea for cytoreduction can be initiated without restriction related to timing of study entry. Hydroxyurea for cytoreduction can be continued concomitantly with CBX-250, with Study Responsible Physician approval.\n    * Intrathecal chemotherapy at the time of diagnostic lumbar puncture at least 24 hours prior to the start of CBX-250 and may continue prophylactic intrathecal chemotherapy beginning in Cycle 2, at the treating physician's discretion.\n12. Hematopoietic Growth Factors: At least 7 days since the completion of therapy with short-acting hematopoietic growth factors and 14 days with long-acting growth factors.\n13. Biologics (e.g. monoclonal antibody therapy): At least 28 days or 5 half-lives, whichever is shorter, have elapsed since the completion of therapy with a biologic agent. Any AE related to prior biologic treatment must be resolved to baseline severity or ≤Grade 1.\n14. Steroids: At least 7 days since systemic glucocorticoid therapy, unless receiving physiologic dosing (equivalent to ≤10 mg prednisone daily) or cytoreductive therapy. Cytoreductive therapy must have approval of the Study Responsible Physician.\n\n    Adequate Organ Function Requirements within 10 Days of Treatment Initiation\n15. Estimated glomerular filtration rate ≥ 45 mL\u002Fmin\u002F1.73 m2 based on local institutional practice for age-appropriate determination (eg, Schwartz formula for pediatric participants or Cockcroft-Gault formula for adults).\n\n    1. Participants ≥18 years: glomerular filtration rate ≥45 mL\u002Fmin\n    2. Participants \\\u003C18 years: ≥45 mL\u002Fmin x (participant's body surface area m2\u002F1.73) • Adequate liver function defined as:\n\n       * Total bilirubin \\\u003C1.5 × the upper limit of normal (ULN) for age or normal conjugated bilirubin, or total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range in participants with well documented Gilbert's syndrome or hemolysis or who require regular blood transfusions.\n       * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C3 × ULN (unless attributed to leukemic involvement with discussion with the Study Responsible Physician).\n\n    Sex and Contraceptive\u002FBarrier Requirements\n16. If a female of childbearing potential, willing to use a highly effective method of contraception or double barrier method from the time of enrollment through 120 days following the last study drug dose.\n17. If male of childbearing potential, agrees to use barrier contraception from the time of enrollment through 120 days following the last study drug dose.\n\n    Informed Consent\n18. Participant or participant's health care proxy is able and willing to provide written informed consent and able to follow study instructions.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nDiagnosis\n\n1. Previous CTSG targeted therapy or treatment with any pMHC T-cell engager.\n2. Isolated extramedullary relapse.\n3. Active central nervous system (CNS) disease. Participants with prior CNS history can be enrolled if the participant has a negative lumbar puncture following completion of intrathecal chemotherapy).\n\n   Infection\n4. Known HIV infection.\n5. Active hepatitis B infection (participants with documented clearance following treatment are allowed).\n6. Active hepatitis C infection (participants with documented clearance following treatment are allowed).\n\n   Pregnancy and Breastfeeding\n7. Pregnant or nursing women: Negative serum pregnancy tests are required during Screening and a negative serum or urine pregnancy test is required within 72 hours prior to receiving the first study drug administration, in females of childbearing potential. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\n   Concurrent Conditions\n8. Cardiac Disease:\n\n   * Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled\u002Funstable angina, congestive heart failure (New York Heart Association Classification Class \\>II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack.\n   * QTc using Fridericia's correction (QTcF) \\>480 msec\n9. Graft-Versus-Host Disease (GVHD): Active acute or chronic GVHD requiring systemic treatment with immunosuppressive medication. Participants may be on physiological doses of steroids.\n10. Concurrent malignancy in the previous 2 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ, melanoma in situ) treated with potentially curative therapy. Concurrent malignancy must be in CR or no evidence of disease (NED) during this timeframe.\n11. History of or any concurrent condition, therapy, or laboratory abnormality that in the Investigator's opinion might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate.\n\n    Concomitant Medications and Interventions\n12. Any commercially available or investigational anti-leukemic therapy other than CBX-250, with the following exceptions:\n\n    • Intrathecal chemotherapy for CNS prophylaxis is permitted after C1 is complete, at the treating physician's discretion.\n13. Participation in another therapeutic interventional clinical study in which an investigational agent was administered within 14 days or 5-halflives, whichever is shorter, of starting CBX-250. Participants may continue with non-interventional follow-up from previous clinical studies.\n14. Any concurrent systemic treatment to prevent GVHD. Topical treatments for GVHD are permitted.\n15. Known allergy or sensitivity to study drug, including excipients.","12 Years",{"count":466,"type":21},72,[24],"Study CBX-250-001 is a Phase 1, open-label, dose-escalation study of CBX-250 in participants with relapsed\u002Frefractory AML, HR-MDS, CMML, and CML. Participants aged ≥ 12 years are planned to be enrolled. CBX-250 will initially be investigated on a fixed step-up dosing schedule. CBX-250 will be administered subcutaneously in 28-day cycles, with the first study drug dose administered on Cycle 1, Day 1. Cycle 1 will consist of a priming phase over 7 days, and a target phase over 28 days. Participants will continue CBX-250 until progressive disease (PD) or unacceptable toxicity. All subsequent treatment cycles will be 28 days.",[470,471,472,31],"High-risk Myelodysplastic Syndrome","Chronic Myelomonocytic Leukemia (CMML)","AML - Acute Myeloid Leukemia",[474,475,476,477,478,479,480,462,481,375],"AML","HR-MDS","CMML","acute leukemia","CBX-250","CBX-250-001","CROSSCHECK","Crossbow","2026-03-12",{"date":484,"type":46},"2026-03-16",{"date":486,"type":46},"2025-07-16",{"date":488,"type":21},"2027-06",{"name":490,"class":171},"Crossbow Therapeutics, Inc.",11,{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":4,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":17,"minAge":149,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":67,"phases":4,"briefSummary":501,"conditions":502,"keywords":4,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":54},"100533749","impact-of-personality-on-adherence-to-tyrosine-kinase-inhibitor-therapy-in-pts-wchronic-myeloid-leukemia-100533749","NCT06229860","Impact of Personality on Adherence to Tyrosine Kinase Inhibitor Therapy in Pts w\u002FChronic Myeloid Leukemia","Impact of Personality on Adherence to Tyrosine Kinase Inhibitor Therapy in Patients With Chronic Myeloid Leukemia","Inclusion Criteria:\n\n* 18 years of age or older\n* Diagnosed with chronic myeloid leukemia (CML) and in the chronic phase (CML-CP)\n* Currently being treated with one of four cancer medications - imatinib, dasatinib, bosutinib, or nilotinib\n* A patient at the UCI Chao Family Comprehensive Cancer Center (CFCCC), or\n* A member of a patient support group organized by the CML Buster Foundation\n* Do not meet any of the criteria listed under \"Exclusion Requirements\"\n\nExclusion Criteria:\n\n* Unable to read and speak English\n* Impaired decisional capacity to consent",{"count":500,"type":21},75,"This is an observational pilot study to examine the association between a patient's personality and adherence to tyrosine kinase inhibitor therapy in patients with chronic myeloid leukemia.",[31,503],"Chronic Phase Chronic Myelogenous Leukemia","2026-03-06",{"date":506,"type":46},"2026-03-10",{"date":508,"type":46},"2024-01-25",{"date":510,"type":21},"2026-12",{"name":512,"class":53},"University of California, Irvine",{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":4,"eligibilityCriteria":519,"healthyVolunteers":62,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":520,"targetDuration":4,"studyType":67,"phases":4,"briefSummary":521,"conditions":522,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":4},"100624717","impact-of-tyrosine-kinase-inhibitors-on-glucose-level-and-lipid-metabolism-in-chronic-myeloid-leukemia-patients-100624717","NCT07413263","Impact of Tyrosine Kinase Inhibitors on Glucose Level and Lipid Metabolism in Chronic Myeloid Leukemia Patients","Impact of Tyrosine Kinase Inhibitors on Glucose and Lipid Metabolism in Chronic Myeloid Leukemia","Inclusion Criteria:\n\n* CML patients free medical history\n\nExclusion Criteria:\n\n* diabetic",{"count":500,"type":21},"to known the impact of drugs that used in CML pt as TKIs on glucose and lipid metabolism",[31],"2026-02-14",{"date":525,"type":46},"2026-02-18",{"date":527,"type":21},"2026-05-01",{"date":529,"type":21},"2028-12-30",{"name":531,"class":53},"Assiut University",{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":538,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":17,"minAge":149,"maxAge":4,"enrollmentInfo":540,"targetDuration":4,"studyType":22,"phases":542,"briefSummary":543,"conditions":544,"keywords":546,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":559},"100528642","phase-1-a-phase-12-clinical-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-efficacy-of-tern-701-in-participants-with-chronic-myeloid-leukemia-cardinal-100528642","NCT06163430","A Phase 1\u002F2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia (CARDINAL)","A Phase 1\u002F2 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia","CARDINAL","Key Inclusion Criteria:\n\n* Male or female participants ≥ 18 years of age at the time of signing the informed consent\n* Have an ECOG performance status score of 0 to 2\n* Have an established cytopathologically confirmed diagnosis of BCR-ABL1 positive CML in Chronic Phase\n* Have received treatment with at least one prior TKI and have treatment failure, suboptimal response, or treatment intolerance\n* Prior treatment with asciminib is allowed\n* Adequate organ function, as assessed by local laboratory\n\nKey Exclusion Criteria:\n\n* Systemic antineoplastic therapy (including prior TKIs, interferon-alfa, therapeutic antibodies, chemotherapy) or other experimental therapy 7 days before the first dose of TERN-701\n* Have completed previous anticancer therapy without resolution of all associated clinically significant toxicity (to ≤ Grade 2 or baseline)",{"count":541,"type":21},180,[24,181],"The goal of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of TERN-701, a highly selective allosteric inhibitor of BCR-ABL1, in participants with previously treated chronic phase - chronic myeloid leukemia (CP-CML).\n\nThe study has two parts: Part 1 of the trial (Dose Escalation) will evaluate sequential dose escalation cohorts of TERN-701 administered once daily.\n\nPart 2 (Dose Expansion) consists of randomized, parallel dose expansion cohorts of TERN-701 that will further evaluate the efficacy and safety of 2 recommended dose levels for expansion selected from Part 1. Part 2m (mutation cohort) will further evaluate the efficacy and safety of 500mg of TERN-701 in previously treated CP-CML participants with certain resistance mutations.\n\nIn both Part 1 and Part 2, participants will receive continuous once daily dosing of TERN-701 divided into 28-day cycles. During the treatment period, participants will have scheduled visits to the trial center at Cycle 1 day 1(C1D1), C1D2 (Part 1 only), C1D8, C1D15, and C1D16 (Part 1 only), followed by Day 1 of Cycles 2 through 7, and Day 1 of every 3 cycles thereafter.\n\nApproximately 180 participants could be enrolled in this trial, up to 80 participants in Part 1 (dose escalation), including optional backfill cohorts, approximately 80 participants in Part 2 (randomized dose expansion), and approximately 20 participants in Part 2m (mutation cohort).\n\nAll participants will receive active trial intervention.\n\nFour dose-level cohorts have been evaluated in Part 1; two dose levels will be evaluated in Part 2 (Randomized Dose Expansion), and one dose level will be evaluated in Part 2m (mutation cohort).",[545,31],"Chronic Myeloid Leukemia, Chronic Phase",[547,375,548,207,414,415,538,549],"allosteric inhibitor of BCR-ABL1","TERN-701","HS-10382","2026-01-08",{"date":552,"type":46},"2026-01-12",{"date":554,"type":46},"2024-03-26",{"date":556,"type":21},"2030-05-31",{"name":558,"class":171},"Terns, Inc.",54,{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":4,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":17,"minAge":149,"maxAge":4,"enrollmentInfo":567,"targetDuration":4,"studyType":22,"phases":569,"briefSummary":570,"conditions":571,"keywords":573,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":54},"100310817","phase-1-selumetinib-and-azacitidine-in-high-risk-chronic-blood-cancers-100310817","NCT03326310","Selumetinib and Azacitidine in High Risk Chronic Blood Cancers","Phase I Study of MEK Inhibitor Selumetinib in Combination With Azacitidine in Patients With Higher Risk Chronic Myeloid Neoplasia: MDS, MDS\u002FMPNs, and Myelofibrosis","Inclusion Criteria:\n\nAll of the following criteria must be met:\n\n* Age greater than or equal to 18 years of age\n* Histologic confirmation of one of the following:\n\n  a. MDS fulfilling all the criteria below: i. International Prognostic Scoring System (IPSS) intermediate-2 or high risk MDS; or Revised International Prognostic Scoring System (IPSS-R) intermediate, high, or very high risk MDS ii. - relapsed\u002Frefractory disease iii. Requiring therapy based on the presence of one or more cytopenias (Hb \\\u003C10 g\u002FdL and\u002For red cell transfusion dependence, platelets- \\\u003C50,000\u002FμL, or ANC \\\u003C1,000\u002F μL) or excess blasts (≥5% in the peripheral blood or bone marrow).\n\n  b. MDS\u002FMPN as defined by the WHO criteria, including CMML, atypical CML, and MDS\u002FMPN-Unclassifiable fulfilling the criteria listed below i. relapsed\u002Frefractory disease ii. Requiring therapy based on the presence of one or more cytopenias (Hb \\\u003C10 g\u002FdL and\u002For red cell transfusion dependence, platelets \\\u003C50,000\u002FμL, or ANC \\\u003C1,000\u002F μL), excess blasts (≥5% in the peripheral blood or bone marrow), or palpable splenomegaly iii. or previously untreated subsets (e.g atypical CML, MDS\u002FMPN unclassifiable) requiring therapy as defined above and in whom no approved therapies exist.\n\n  c. Myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis fulfilling the criteria listed below: i. Intermediate-2 or high risk disease according to the Dynamic International Prognostic Scoring System (DIPSS) classification ii. refractory or intolerant to JAK inhibitor therapy, or deemed - ineligible for ruxolitinib therapy due to pre- existing cytopenias (thrombocytopenia \\\u003C50,000\u002FuL, anemia hemoglobin \\\u003C9g\u002FdL or red cell transfusion dependence).Requiring further therapy based on the presence of one or more cytopenias (Hb \\\u003C10 g\u002FdL and\u002For red cell transfusion dependence, platelets \\\u003C50,000\u002FμL, or ANC \\\u003C1,000\u002FμL), excess blasts (≥5% in the peripheral blood or bone marrow), or palpable splenomegaly\n* No history of prior exposure to a MEK inhibitor\n* ECOG performance status of ≤ 2\n* Adequate renal function, defined as serum creatinine ≤ 1.5 x ULN or creatinine clearance \\>30 mL\u002Fmin based on the Cockroft-Gault equation: (140 - Age) x (weight in kg) x (0.85 if female) \u002F 72 x serum creatinine\n* Adequate liver function, defined as conjugated bilirubin ≤ 2 x ULN as well as aspartate transaminase (AST) and alanine aminotransaminase (ALT) ≤ 3 x ULN\n* Patients must be at least 2 weeks from major surgery, radiation therapy, participation in other investigational trials and must have recovered from clinically significant toxicities of these prior treatments\n* Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment\n* Female and male patients must use an effective contraceptive method during the study and for at least 6 months thereafter\n* Ability to understand and willingness to sign a written informed consent document\n\nExclusion Criteria:\n\nPatients are excluded if any one of the following is present:\n\n* Receipt of any anti-cancer therapy within 14 days prior to study entry, with the exception of hydroxyurea. If clinically indicated in order to keep WBC \\\u003C30,000\u002FuL, hydroxyurea may be continued through the first cycle.\n* Concurrent active malignancy, with the exception of early stage basal cell or squamous cell skin cancer\n* Active cardiac conditions, including any of the following:\n\n  1. Uncontrolled hypertension (BP \\>150\u002F95 mmHg despite medical therapy)\n  2. Acute coronary syndrome within 6 months prior to starting treatment\n  3. Uncontrolled angina despite medical therapy\n  4. Symptomatic heart failure (NYHA class II-IV despite medical therapy)\n  5. Baseline LV EF \\\u003C50% measured by either echocardiography or MUGA scan\n  6. Severe valvular heart disease\n  7. Atrial fibrillation with ventricular rate \\>100 bpm on EKG at rest.\n* Ophthalmologic conditions, including any of the following:\n\n  1. Current or past history of central serous retinopathy\n  2. Current or past history of retinal vein occlusion\n  3. Intraocular pressure (IOP) \\>21 mmHg or uncontrolled glaucoma\n* Any uncontrolled concurrent illness that, in the judgment of the investigators or treating physician, may put the patient at undo risk including but not limited to active infection, symptomatic cardiac or pulmonary disease, ventricular arrhythmia, or psychiatric illness.\n* Pregnant or lactating patients",{"count":568,"type":21},18,[24],"This is a phase I, open-label, dose-escalation study to determine the MTD of selumetinib when combined with the standard dose of azacitidine. Treatment will begin within 28 days of screening procedures. Treatment will continue indefinitely, provided that the patient continues to derive benefit. A patient will be taken off study for reasons described in detail in section 3.12 including disease progression, unacceptable toxicity, inter-current illness, withdrawal of consent, or at the discretion of the investigator. Patients will be followed for 12 weeks after the last dose of study drug, until any study treatment related toxicities have stabilized, or until death. The total duration of the study is expected to be approximately 24 months.",[31,572],"Myelofibroses",[31,574,575,576],"Myelofibrosis","selumetinib","azacitidine","2025-12-19",{"date":579,"type":46},"2025-12-29",{"date":581,"type":46},"2018-09-04",{"date":583,"type":21},"2027-09-04",{"name":585,"class":53},"University of Chicago",{"id":587,"slug":588,"hasResults":12,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":592,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":17,"minAge":149,"maxAge":594,"enrollmentInfo":595,"targetDuration":4,"studyType":22,"phases":597,"briefSummary":598,"conditions":599,"keywords":604,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":613,"completionDateStruct":615,"leadSponsor":617,"locationsCount":54},"100611294","phase-2-optimization-of-post-transplantation-benadamustine-and-cyclophosphamide-in-patients-with-high-risk-myeloid-malignancies-and-a-partially-mismatched-donor-100611294","NCT07238712","Optimization of Post-transplantation Benadamustine and Cyclophosphamide in Patients With High-risk Myeloid Malignancies and a Partially Mismatched Donor","Optimization of Post-transplantation Benadamustine and Cyclophosphamide in Patients With High-risk Myeloid Malignancies and a Partially Mismatched Donor (APTBCy)","APTBCy","Inclusion Criteria:\n\n* Patients with indication for allogeneic hematopoietic stem cell transplantation\n* Patients with \\\u003C10\u002F10 HLA-matched related or unrelated donor available. The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1.\n* Peripheral blood stem cells or bone marrow as a graft source\n* Diagnosis:\n\nAcute myeloid leukemia Chronic myeloid leukemia, Ph+ Myelodysplastic Syndromes Myeloprolipherative neoplasms - High-risk disease defined as: Acute myeloid leukemia: \\>5% of clonal blasts in bone marrow despite adequate previous induction therapy or allogeneic stem cell transplantation Myelodysplastic Syndrome: \\>5% of blasts despite previous therapy Myeloid malignancy with with -7 or complex karyotype, or p53 mutation regardless of blast count in bone marrow Treatment-related myelodysplastic syndrome Second or subsequent allogeneic HCT after relapse of a myeloid malignancy Chronic myelomonocytic leukemia Myeloprolipherative neoplasms, unclassifiable\n\n\\- No severe concurrent illness\n\nExclusion Criteria:\n\n* Patients with indication for allogeneic hematopoietic stem cell transplantation\n* Patients with \\\u003C10\u002F10 HLA-matched related or unrelated donor available. The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1.\n* Peripheral blood stem cells or bone marrow as a graft source\n* Diagnosis:\n\nAcute myeloid leukemia Chronic myeloid leukemia, Ph+ Myelodysplastic Syndromes Myeloprolipherative neoplasms - High-risk disease defined as: Acute myeloid leukemia: \\>5% of clonal blasts in bone marrow despite adequate previous induction therapy or allogeneic stem cell transplantation Myelodysplastic Syndrome: \\>5% of blasts despite previous therapy Myeloid malignancy with with -7 or complex karyotype, or p53 mutation regardless of blast count in bone marrow Treatment-related myelodysplastic syndrome Second or subsequent allogeneic HCT after relapse of a myeloid malignancy Chronic myelomonocytic leukemia Myeloprolipherative neoplasms, unclassifiable\n\n\\- No severe concurrent illness","70 Years",{"count":596,"type":21},60,[181],"Optimization of bendamustine-containg graft-versus-host disease (GVHD) prophylaxis to reduce the incidence of secondary haemophagocytic lymphohistiocytosis and GVHD",[600,31,601,602,603],"Acute Myeloid Leukemia (AML)","Myelodysplastic Syndromes (MDS)","Myeloprolipherative Neoplsm","Atypical Chronic Myeloid Leukemia",[605,606,607,608,609],"Post-transplantation cyclophosphamide","Post-transplantation bendamustine","graft-versus-host disease","abatacept","ruxolitinib","2025-11-16",{"date":612,"type":46},"2025-11-20",{"date":614,"type":46},"2025-05-10",{"date":616,"type":21},"2026-12-10",{"name":618,"class":53},"St. Petersburg State Pavlov Medical University",{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":4,"eligibilityCriteria":625,"healthyVolunteers":12,"sex":17,"minAge":149,"maxAge":4,"enrollmentInfo":626,"targetDuration":4,"studyType":22,"phases":628,"briefSummary":629,"conditions":630,"keywords":635,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":641,"lastUpdatePostDateStruct":642,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":648,"locationsCount":650},"100382468","phase-1-study-of-hqp1351-in-subjects-with-refractory-cml-and-ph-all-100382468","NCT04260022","Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL","A Phase Ib Study of the Pharmacokinetics, Safety and Efficacy of Orally Administered HQP1351 in Subjects With Refractory Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)","Inclusion Criteria:\n\n* For HQP1351 monotherapy, patients must have CML in any phase (CP, AP, or BP of any phenotype) or Ph+ ALL, with or without T315I mutation\n* For Cohort D, patients with Ph+ BCP ALL or CML LBP must be resistant or intolerant to at least one second or later generation TKI, such as dasatinib, nilotinib, bosutinib and ponatinib, despite optimal supportive care\n* For HQP1351 monotherapy only: Be previously treated with and developed resistance or intolerance to at least two TKIs including ponatinib, imatinib, dasatinib, nilotinib, bosutinib, and asciminib. For patients with a T315I mutation, number of pretreated TKIs is not restricted.\n\n  1. The definition of resistance to first-line TKI treatment refers to European Leukemia Net (ELN) recommendations. The definitions are the same for patients in CP, AP, BP, and Ph+ ALL, and apply also to second-line treatment, when first-line treatment was changed for intolerance. The patients must meet at least one criterion:\n\n     1. Three months after the initiation of therapy: non-complete hematologic response (CHR) and\u002For Ph+ \\>95%\n     2. Six months after the initiation of therapy: BCR-ABL1\\>10% and\u002For Ph+ \\>35%\n     3. Twelve months after the initiation of therapy: BCR-ABL1\\>1% and\u002For Ph+ \\>0%\n     4. Then, and at any time after the initiation of therapy: Loss of CHR, or loss of complete cytogenetic response (CCyR), or confirmed loss of major molecular response (MMR) (In 2 consecutive tests, of which one with a BCR-ABL1 transcripts level ≥1%), mutations, clonal chromosome abnormalities in Ph+ cells (CCA\u002FPh+)\n  2. The definition of resistance to second-line TKI treatment\n\n     a) For CML CP patients: the patients must meet at least one criterion as follows:\n\n     i.) Three months after the initiation of therapy: No CHR or Ph+ \\>95% or new mutations\n\n     ii.) Six months after the initiation of therapy: BCR-ABL1\\>10% and\u002For Ph+ \\>65% and\u002For new mutations\n\n     iii.) Twelve months after the initiation of therapy: BCR-ABL1\\>1% and\u002For Ph+ \\>35% and\u002For new mutations\n\n     iv.) Then, and at any time after the initiation of therapy: Loss of CHR or loss of CCyR, new mutations, confirmed loss of MMR (In 2 consecutive tests, of which one with a BCR-ABL1 transcripts level ≥1%), clonal chromosome abnormalities in Ph+ cells (CCA\u002FPh+)\n\n     b) For CML AP patients: the patients must meet at least one criterion as follows:\n\n     i.) Three months after the initiation of therapy: failure to achieve a major hematologic response (MaHR)\n\n     ii.) At any time after the initiation of therapy, the loss of a MaHR, confirmed in at least 2 consecutive analyses separated by at least 4 weeks\n\n     iii.) At any time after the initiation of therapy, the development of new BCR-ABL kinase domain mutations in the absence of a MaHR\n\n     c) For CML BP and Ph+ ALL patients: the patients must meet at least one criterion as follows:\n\n     i) One month after the initiation of therapy: failure to achieve a MaHR\n\n     ii) At any time after the initiation of therapy, the loss of a MaHR, confirmed in at least 2 consecutive analyses separated by at least 1 week\n\n     iii) At any time after the initiation of therapy, the development of new BCR-ABL kinase domain mutations in the absence of a MaHR\n  3. Intolerance to TKIs is defined as:\n\n     1. Non-hematological AEs: patients with grade 3 or 4 toxicity during TKIs treatment, or with persistent grade 2 toxicity, unresponsive to optimal management, including dose adjustments in the absence of a CCyR for CP patients or MaHR for AP\u002FBP or Ph+ ALL patients\n     2. Hematological AEs: patients with grade 3 or 4 toxicity during TKIs treatment, that is recurrent after unresponsive after optimal management, including dose adjustments in the absence of a CCyR for CP patients or MaHR for AP\u002FBP or Ph+ ALL patients\n* Patients providing written informed consent before initiation of any study-related activities\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2\n* Minimum life expectancy of 3 months or more\n* Patients with adequate organ function as defined below:\n\n  1. Creatinine \\\u003C 2 × upper limit of normal (ULN); or, creatinine \\> 2 × ULN, with 24h glomerular filtration rate (GFR) ≥ 30 mL\u002Fmin (Cockcroft-Gault)\n  2. Serum albumin ≥ 3.0 g\u002FdL\n  3. Total bilirubin \\\u003C 1.5 × ULN\n  4. Aspartate aminotransferase (AST \\[Serum glutamic oxaloacetic transaminase (SGOT)\\]) and alanine aminotransferase (ALT \\[serum glutamate-pyruvate transaminase (SGPT)\\]) \\\u003C 3 × ULN for institution (\\\u003C5×ULN if liver involvement with leukemia)\n  5. Serum amylase and lipase ≤ 1.5 × ULN\n  6. Prothrombin time (PT) ≤ 1.5 × ULN\n* Heart function: Left ventricular ejection fraction (LVEF) \\> 50%\n* Normal QT interval corrected Fridericia (QTcF) interval on screening electrocardiogram (ECG) evaluation: male ≤450ms, female ≤470ms\n* For females of childbearing potential, a negative pregnancy test must be established before enrollment. And the eligible female and male patients with childbearing potential must agree to use an effective form of contraception with their sexual partners throughout participation in this study\n* Ability to comply with study procedures, in the Investigator's opinion\n\nExclusion Criteria:\n\n* Received TKI therapy within 5 half-lives or 7 days prior to first dose of HQP1351, whichever is shorter, or any adverse events (AEs) (except alopecia and pigmentation) not recovered to CTCAE v5.0 grade 0-1 due to any other treatments\n* Received other therapies as follows:\n\n  1. For CP and AP patients, received hydroxyurea or anagrelide within 24 hours prior to the first dose of HQP1351; or, interferon, immunotherapy or cytarabine within 14 days prior to the first dose of HQP1351; or, any other radiotherapy, cytotoxic chemotherapy or investigational therapy within 28 days prior to receiving the first dose of HQP1351\n  2. For BP patients, received chemotherapy within 7 days prior to the first dose of HQP1351\n  3. For Ph+ ALL patients, received corticosteroids within 24 hours before the first dose of HQP1351, or received chemotherapy within 7 days prior to the first dose of HQP1351\n  4. Patients who are currently receiving treatment with a medication that has the potential to interact with HQP1351\n  5. Patients who had been treated with HQP1351\n  6. Patients requiring immunosuppressive therapy other than short time of steroid\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs\n* Patients with cardiovascular diseases, including uncontrolled high blood pressure (HBP) (that is blood pressure \\>140\u002F90mmHg.); or, receiving drugs that can cause prolonged QT interval. Patients with well controlled HBP can be considered to be included. (\"well controlled HBP\" is defined as: HBP can be ≤ 140\u002F90mmHg with antihypertensive treatment). Those requiring 3 or more antihypertensive medications should be discussed with the medical monitor.\n* Have clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:\n\n  1. Any history of myocardial infarction (MI) within 6 months or unstable angina within 3 months\n  2. Any history of cerebrovascular accident within 1 year, or transient ischemic attack (TIA) within 3 months\n  3. Any history of peripheral vascular infarction, including visceral infarction within 6 months\n  4. Congestive heart failure (CHF) (New York Heart Association \\[NYHA\\] class III or IV) within 6 months prior to enrollment, or left ventricular ejection fraction (LVEF) less than lower limit of normal, per local institutional standards, within 6 months prior to enrollment\n  5. History of clinically significant (as determined by the treating physician) atrial arrhythmia or any history of ventricular arrhythmia\n  6. Venous thromboembolism, including deep venous thrombosis or pulmonary embolism, within 3 months prior to enrollment. Patients who have experienced a venous thromboembolic event should only be eligible if the condition is well controlled with optimal intervention (as determined by the treating physician). Continued prophylactic anticoagulation is acceptable.\n  7. Patients with revascularization procedures including cardiac bypass within the 6 months and stenting within the past 3 months should be excluded.\n* Have history of autologous or allogeneic stem cell transplant, or with active graft-versus-host disease (GVHD), or active immune suppression in recent 6 months prior to informed consent date or active immune suppression in recent 6 months prior to informed consent date\n* CML CP patients with CCyR\n* Patients who have a significant bleeding disorder unrelated to CML or Ph+ ALL\n* Patients who had a major surgery within 4 weeks prior to study entry or have not recovered from side effects of such surgery which the Investigator considers not appropriate for enrollment\n* Cytologically confirmed central nervous system (CNS) involvement (if asymptomatic, spinal fluid examination is not necessary prior to first treatment)\n* Patients with another primary malignancy within 1 year of study entry. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection and are considered disease-free at the time of study entry.\n* Have ongoing or active infection, including known history of immunodeficiency virus (HIV) or HIV antibody positive, hepatitis B virus (HBV) or HBsAg positive, hepatitis C virus (HCV). Patients who have positive HCV antibody must have an undetectable HCV viral load.\n* Patients with COVID-19 who now present with positive swab\n* Patients who have poorly controlled diabetes, defined as HbA1C values of \\> 7.5%. Patients with pre-existing, well-controlled diabetes are not excluded.\n* Known allergy to any components in the study drug\n* Pregnant or lactating\n* Patients who have any conditions or illness that, according to the opinions of the investigator or the medical monitor, would comprise patient safety or interfere with the evaluation of safety and efficacy to the study drug",{"count":627,"type":21},242,[24],"A multi-center, open-label, randomized, phase Ib study to evaluate the pharmacokinetics (PK) of HQP1351 and to determine the recommended phase 2 dose (RP2D) of HQP1351 in subjects with CML chronic phase (CP), accelerated phase (AP), or blast phase (BP) or with Ph+ ALL, who have experienced resistance or intolerance to at least two tyrosine kinase inhibitors (TKIs) or in subjects with Ph+ B-cell precursor (BCP) ALL or lymphoid blast phase CML (CML LBP), who have experienced resistance or intolerance to at least one second or later generation TKI.",[631,632,31,633,634],"Leukemia, Myeloid, Chronic","Myeloid Leukemia","Philadelphia Positive Acute Lymphoblastic Leukemia","B Cell Precursor Type Acute Leukemia",[636,637,638,639,640],"T315I mutation","Chronic Phase","Accelerated Phase","Blast Phase","Lymphoid blast phase","2025-11-04",{"date":643,"type":46},"2025-11-05",{"date":645,"type":46},"2020-01-09",{"date":647,"type":21},"2030-03-31",{"name":649,"class":171},"Ascentage Pharma Group Inc.",9,{"id":652,"slug":653,"hasResults":12,"nctId":654,"briefTitle":655,"officialTitle":656,"acronym":4,"eligibilityCriteria":657,"healthyVolunteers":12,"sex":17,"minAge":149,"maxAge":4,"enrollmentInfo":658,"targetDuration":4,"studyType":22,"phases":660,"briefSummary":662,"conditions":663,"keywords":672,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":678,"lastUpdatePostDateStruct":679,"startDateStruct":681,"completionDateStruct":683,"leadSponsor":685,"locationsCount":54},"100546708","early-phase-1-darzalex-faspro-daratumumab-and-hyaluronidase-fihj-before-standard-desensitization-and-allogeneic-peripheral-blood-stem-cell-transplantation-in-adult-patients-at-high-risk-for-primary-graft-failure-secondary-to-donor-specific-antibodies-100546708","NCT06398457","Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies","A Pilot Study of Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies","Inclusion Criteria:\n\n1. Participates must meet all other institutional criteria for the planned reduced intensity conditioning allogeneic peripheral blood stem cell transplant (RIC alloHSCT) as defined in Johns Hopkins BMT Policy; all potential non-cord blood donor sources are included: matched related, haploidentical, matched unrelated, mismatched unrelated.\n2. Participants must be ≥18 years of age.\n3. Participants must have adequate organ function for undergoing RIC allogeneic peripheral blood stem cell transplant, and for undergoing a clinical trial.\n\n   a. Hematologic. i. White blood cell (WBC). ANC ≥ 500\u002Fmm3 (growth factor support allowed). ii. Hemoglobin. No specific cut-off. (PRBC transfusion allowed). iii. Platelets. Platelets ≥ 10,000\u002Fmm3 (platelet transfusion allowed). b. Liver. Bilirubin ≤ 3.0 mg\u002FdL (unless due to Gilbert's syndrome or hemolysis), and Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) \\\u003C 5x Upper limit of normal (ULN) c. Renal. Serum creatinine ≤ 2.0 mg\u002FdL. d. Cardiac. Left ventricular ejection fraction ≥ 35%. e. Pulmonary. FEV1 ≥ 50%.\n4. Subjects are eligible if there are high levels of Donor Specific Antibody levels based on protocol specific scoring system regardless of prior attempts at standard desensitization.\n5. Participants must have a no other readily available suitable alternative donor.\n6. All potential Participants must be pre-approved by BMT faculty consensus.\n7. Participants must have adequate willingness to participate in a clinical trial.\n\nExclusion Criteria:\n\n1. Previous exposure to Daratumumab-SC or other anti-CD38 therapy\n\n   1. Exposure to Daratumumab-SC or other anti-CD38 therapies (unless a re-treatment study)\n   2. Exposure to an investigational drug (including investigational vaccine) or invasive investigational medical device for any indication within 4 weeks or 5 pharmacokinetic half-lives, whichever is longer.\n   3. Focal radiation therapy within 14 days prior to beginning of planned RIC allogeneic peripheral blood stem cell transplant regimen with the exception of palliative radiotherapy for symptomatic management but not on measurable extramedullary plasmacytoma\n2. Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \\\u003C 50% of predicted normal. Note that FEV1 testing is required for participants suspected of having COPD and participants must be excluded if FEV1 is \\\u003C 50% of predicted normal.\n3. Moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification. Note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate.\n4. Known hypersensitivity or intolerance to boron or mannitol, sorbitol, corticosteroids, monoclonal antibodies or human proteins, or the excipients\n5. Diagnosis of multiple myeloma or Amyloid light-chain (AL) amyloidosis\n6. A planned myeloablative alloBMT or the planned use of bone marrow or cord blood as a stem cell source\n7. History of HIV infection at any time in past.\n8. Seropositive for hepatitis B (HBV) (defined by a positive test for hepatitis B surface antigen \\[HBsAg\\] positive, or antibodies to hepatitis B surface and\u002For core antigens \\[antiHBs or antiHBc, respectively\\] with hepatitis B virus \\[HBV\\]- DNA quantitation positive). Patients who are positive for antiHBs and\u002For antiHBc must have a negative polymerase chain reaction (PCR) for HBV-DNA quantitation result during screening. Patients with serologic findings suggestive of HBV vaccination (antiHBs positivity as the only serologic marker) AND a known history of prior HBV vaccination do not need to be tested for HBV DNA by PCR. Those who are PCR positive will be excluded.\n9. Seropositive for hepatitis C (except in the setting of a sustained virologic response (SVR), defined as aviremia at least 12 weeks after completion of antiviral therapy)\n10. Clinically significant cardiac disease, including:\n\n    1. Myocardial infarction within 6 months before RIC alloHSCT or unstable or uncontrolled disease\u002Fcondition related to or affection cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV)\n    2. Uncontrolled cardiac arrhythmia",{"count":659,"type":21},8,[661],"EARLY_PHASE1","This research is being done to investigate the safety and effectiveness of Darzalex Faspro (daratumumab and hyaluronidase-fihj) (a monoclonal antibody that targets plasma cells that make antibodies) and whether it can lower donor specific antibodies (DSA) levels to low enough levels to permit patients to proceed with allogeneic peripheral blood transplant (alloBMT). Those being asked to participate have high DSA levels that puts those being asked to participate at high risk of rejecting the available donor's blood stem cells and making those being asked to participate ineligible to receive a stem cell transplant.",[664,665,600,601,666,667,668,669,670,671,31,574],"Hematologic Malignancy","Bone Marrow Transplant Rejection","Acute Lymphoblastic Leukemia (ALL), Adult","Multiple Myeloma","Aplastic Anemia","Lymphoma","Non Hodgkin Lymphoma","Hodgkin Lymphoma",[673,674,675,676,677],"DSA","donor specific antibodies","desensitization","BMT","allogeneic stem cell transplant","2025-09-25",{"date":680,"type":46},"2025-09-26",{"date":682,"type":46},"2024-09-19",{"date":684,"type":21},"2027-03",{"name":686,"class":53},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",{"id":688,"slug":689,"hasResults":12,"nctId":690,"briefTitle":691,"officialTitle":691,"acronym":4,"eligibilityCriteria":692,"healthyVolunteers":12,"sex":17,"minAge":149,"maxAge":4,"enrollmentInfo":693,"targetDuration":4,"studyType":67,"phases":4,"briefSummary":695,"conditions":696,"keywords":697,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":701,"lastUpdatePostDateStruct":702,"startDateStruct":704,"completionDateStruct":706,"leadSponsor":708,"locationsCount":4},"100604209","expression-pattern-and-possible-clinical-significance-of-cd81-in-myeloid-leukemia-100604209","NCT07146542","Expression Pattern and Possible Clinical Significance of CD81 In Myeloid Leukemia","Inclusion Criteria:\n\n* 1\\. Myeloid leukemia patients 2. Patients of both genders (Males and females) at any age 3. Cases are de novo (Not on treatment)\n\nExclusion Criteria:\n\n* . Patients with other haematological neoplasms (ALL,CLL, plasma cell myeloma, etc)\n\n  * Patients under any therapeutic intervention\n  * Patients with current or previous other malignancies at time of diagnosis",{"count":694,"type":21},66,"The goal of this study is to understand how the protein CD81 affects myeloid leukemia (especially AML) and whether it can help predict patient outcomes or guide treatment.\n\nThe main question it aims to answer:\n\nIs high CD81 expression in myeloid leukemia cells linked to more aggressive disease, poorer treatment response, or shorter survival in patients?\n\nParticipants:\n\n* Newly diagnosed myeloid leukemia patients (primary focus on AML)\n* Bone marrow or blood samples will be collected during routine diagnostic procedures",[28,31],[698,699,375,700,347],"CD81","AMl","Myeloid","2025-08-21",{"date":703,"type":46},"2025-08-28",{"date":705,"type":21},"2025-10-01",{"date":707,"type":21},"2028-03",{"name":531,"class":53},{"id":710,"slug":711,"hasResults":12,"nctId":712,"briefTitle":713,"officialTitle":714,"acronym":715,"eligibilityCriteria":716,"healthyVolunteers":12,"sex":17,"minAge":149,"maxAge":4,"enrollmentInfo":717,"targetDuration":4,"studyType":22,"phases":719,"briefSummary":720,"conditions":721,"keywords":724,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":726,"lastUpdatePostDateStruct":727,"startDateStruct":729,"completionDateStruct":731,"leadSponsor":733,"locationsCount":491},"100547589","phase-2-pearl-study-potential-of-asciminib-in-the-early-treatment-of-cml-100547589","NCT06409936","PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML","Asciminib as Single Agent or in Combination With Nilotinib in the 1st-line Treatment of BCR-ABL1+ Chronic Myeloid Leukemia: a Randomized GIMEMA-GELMC Phase II Study PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML","PEARL","Inclusion Criteria:\n\n* Cytogenetic and molecular confirmed diagnosis of Ph+ and BCR::ABL1+ CML\n* Age ≥ 18 years\n* Early chronic phase, less than 3 months from diagnosis\n* Evidence at the time of study entry of typical BCR::ABL1 RNA transcripts e13a2 or e14a2 (b2a2 or b3a2), which are required for BCR::ABL1 international scale reporting\n* Prior treatment with any TKI for 30 days or less; prior treatment with hydroxyurea or anagrelide is allowed\n* ECOG performance status of 0, 1 or 2\n* Adequate end organ function as defined by Total bilirubin ≤ 1.5 x ULN except for patients with Gilbert's syndrome who may only be included if total bilirubin ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN Aspartate transaminase (AST) ≤ 3.0 x ULN Alanine transaminase (ALT) ≤ 3.0 x ULN Serum amylase ≤ ULN Serum lipase ≤ ULN Alkaline phosphatase ≤ 2.5 x ULN, unless considered tumor related Creatinine clearance \\> 50 ml\u002Fmin using Cockcroft-Gault formula\n* Signed written informed consent according to ICH\u002FEU\u002FGCP and national local laws prior to any study procedure\n* An effective form of contraception with their sexual partners from enrolment through 30 days after the end of treatment\n\nExclusion Criteria:\n\n* CML in blast phase (BP) or in second chronic phase after previous BP, according to WHO criteria\n* Previous treatment with TKIs for more than 30 days\n* Refusal or impossibility to give an informed consent\n* History or current diagnosis of cardiac disease indicating significant risk of safety for patients participating in the study such as uncontrolled or significant cardiac disease, including any of the following: recent myocardial infarction (within last 6 months), uncontrolled congestive heart failure, unstable angina (within last 6 months), clinically significant (symptomatic) cardiac arrhythmias (e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker).\n* Severe and\u002For uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. uncontrolled diabetes, active or uncontrolled infection)\n* History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis\n* History of acute or chronic liver disease\n* History of other active malignancy within 2 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively\n* Known history of Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), or Hepatitis C (HCV) infection. Testing for Hepatitis B surface antigen (HBs Ag) and Hepatitis B core antibody (HBc Ab \u002F anti HBc) will be performed at study entry\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery)\n* Pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.\n* Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 30 days after the end of treatment",{"count":718,"type":21},160,[181],"A phase 2, interventional, randomized unblinded study will be conducted in newly diagnosed CP CML patients, to investigate the efficacy and the safety of asciminib at a dose of 80 mg QD as single agent (arm A) or 40 mg BID in combination with nilotinib 300 mg BID (arm B).\n\nAll patients in both arm A and arm B will be treated for a minimum of 2 years (core phase). If they will have achieved a DMR (MR4), or if it will be in the interest of the patient, the treatment will be continued.\n\nDuring the consolidation phase (2 years) asciminib will be continued at the same dose in both arms; in the combination arm the nilotinib dose will be reduced to 300 mg daily.\n\nThe patients maintaining a stable MR4 up to the end of the fourth year will discontinue the treatment (TFR phase). The rate of TFR at 5 year (1 year after discontinuation) will be evaluated.",[722,545,723,31],"CML, Chronic Phase","Chronic Myeloid Leukemia, BCR\u002FABL-Positive",[208,725],"nilotinib","2025-07-07",{"date":728,"type":46},"2025-07-08",{"date":730,"type":46},"2025-06-26",{"date":732,"type":21},"2032-06",{"name":218,"class":53},{"id":735,"slug":736,"hasResults":12,"nctId":737,"briefTitle":738,"officialTitle":739,"acronym":740,"eligibilityCriteria":741,"healthyVolunteers":12,"sex":17,"minAge":149,"maxAge":150,"enrollmentInfo":742,"targetDuration":4,"studyType":22,"phases":744,"briefSummary":746,"conditions":747,"keywords":4,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":748,"lastUpdatePostDateStruct":749,"startDateStruct":751,"completionDateStruct":753,"leadSponsor":755,"locationsCount":54},"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.",{"count":743,"type":21},285,[745],"PHASE3","A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)",[31,375,722],"2025-05-29",{"date":750,"type":46},"2025-06-03",{"date":752,"type":46},"2024-02-05",{"date":754,"type":21},"2026-02",{"name":649,"class":171}]