[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"philadelphia-chromosome-positive\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:philadelphia-chromosome-positive":60},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,70,95,119],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100539803","phase-1-phase-iii-study-of-the-combination-of-blinatumomab-and-asciminib-in-patients-with-philadelphia-chromosome-positive-acute-lymphoblastic-leukemia-100539803",false,"NCT06308588","Phase I\u002FII Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Diagnosis of one of the following:\n\n   a) Participants ≥18 years of age with previously untreated or minimally pretreated Ph-positive ALL who are not suitable candidates for intensive chemotherapy. Participants who have received no more than one or two courses of chemotherapy with or without other TKIs are considered minimally pretreated and still eligible if they have persistently detectable MRD.\n\n   i. If they are in morphologic remission at enrollment, they are evaluable only MRD responses, RFS and OS b) Participants ≥ 12 years of age with relapsed\u002Frefractory Ph-positive ALL or with previously treated lymphoid blast phase CML\n2. Performance status ≤2 (ECOG Scale) if age ≥18 years or Lansky ≥50 if age \\\u003C18 years\n3. Weight ≥40kg\n4. Adequate liver function as defined by the following criteria (unless the increased values are judged to be leukemia disease related):\n\n   1. Total serum bilirubin ≤ 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome\n   2. Alanine aminotransferase (ALT) ≤ 3 x ULN, OR\n   3. Aspartate aminotransferase (AST) ≤ 3 x ULN\n5. Adequate renal function defined as:\n\n   a) Creatinine clearance ≥30 mL\u002Fmin\n6. Adequate pancreatic function as defined by the following criteria:\n\n   a) Serum lipase and amylase \\\u003C 1.5 x ULN\n7. Adequate cardiac function as assessed clinically by history and physical examination.\n8. For females of childbearing potential, a negative urine pregnancy test must be documented\n9. Willingness to use adequate contraception prior to study entry, for the duration of study participation, and for 4 months after completion of study participation. For women of child-bearing potential, adequate methods of contraception include: complete abstinence, 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\n10. Ability to understand and the willingness to sign a written informed consent document.\n11. Signed informed consent\n\nExclusion Criteria:\n\n1. Active serious infection not controlled by oral or intravenous antibiotics.\n2. Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year.\n3. Active Grade III-V cardiac failure as defined by the New York Heart Association Criteria.\n4. Prolonged QTc interval on pre-entry electrocardiogram (\\> 470 msec) unless corrected after electrolyte replacement or approved by cardiologist\n5. History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. (Participants with active CNS leukemia will NOT be excluded)\n6. Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator. Cytarabine 2 g\u002Fm2 (or alternative) for cytoreduction is permitted.\n7. Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.","ALL","18 Years",{"count":18,"type":19},40,"ESTIMATED","INTERVENTIONAL",[22,23],"PHASE1","PHASE2","To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.",[26,27],"Philadelphia Chromosome-Positive","Acute Lymphoblastic Leukemia","RECRUITING","2026-06-04",{"date":31,"type":32},"2026-06-08","ACTUAL",{"date":34,"type":32},"2024-08-05",{"date":36,"type":19},"2029-05-01",{"name":38,"class":39},"M.D. Anderson Cancer Center","OTHER",2,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":20,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100331014","phase-2-dexrazoxane-hydrochloride-in-preventing-heart-related-side-effects-of-chemotherapy-in-participants-with-blood-cancers-100331014","NCT03589729","Dexrazoxane Hydrochloride in Preventing Heart-Related Side Effects of Chemotherapy in Participants With Blood Cancers","Cardioprotection With Dexrazoxane in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS), Myeloid Blast Phase of Chronic Myeloid Leukemia (CML), Ph+ AML, and Myeloid Blast Phase of Myeloproliferative Neoplasms","Inclusion Criteria:\n\n* Baseline left ventricular ejection fraction (LVEF) is greater than or equal to 50% by echocardiography (echo) or multigated acquisition (MUGA) scan.\n* Patients of child bearing potential should use contraception.\n* Patients with a diagnosis of acute myeloid leukemia (AML), or high risk myelodysplastic syndrome (MDS) (\\>= 10% blasts or International Prognostic Scoring System \\[IPSS\\] \\>= intermediate-2) or high-risk myeloproliferative neoplasm will be eligible.\n* Patients with untreated or previously untreated chronic myeloid leukemia (CML) in myeloid blast phase or (Philadelphia chromosome-positive (Ph+) AML are also eligible.\n* Patients with myeloproliferative neoplasms in blast phase will be eligible.\n* Patients with isolated extramedullary myeloid neoplasm will be eligible.\n* Patients with active CNS (central nervous system) disease are eligible.\n* Bilirubin \\\u003C 2mg\u002FdL.\n* AST (aspartate aminotransferase) and\u002For ALT (alanine aminotransferase) \\\u003C 3 x ULN (upper limit of normal) - or \\\u003C 5 x ULN if related to leukemic involvement.\n* Creatinine \\\u003C 1.5 x ULN.\n* Hyperbilirubinemia is allowed if due to Gilbert's hyperbilirubinemia.\n* A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.\n* Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.\n* Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.\n* Prior therapy for any of the cohorts may include with hydroxyurea, rescue doses of cytarabine, various combination-chemotherapy regimens, hematopoietic growth factors, azacytidine, decitabine, ATRA (all-trans retinoic acid).\n* Cohort 1: Frontline cohort patients are eligible in the frontline cohort if they are untreated or previously treated already in CR if they received 3 or fewer cycles of previous chemotherapy (including either 1 induction and 2 consolidations or 2 inductions and 1 consolidation).\n* Cohort 2: Salvage cohort in 1st and 2nd salvage patients are eligible in the salvage cohort 2 if they have active disease after first or second relapse or if they are in CR after previously documented first or second relapse as long as they if they have received 3 or fewer cycles of chemotherapy to achieve the most current CR.\n* Cohort 3: Salvage cohort in 3rd salvage and beyond patients may be eligible in salvage cohort 3 if they have active disease after 3rd or greater relapse or if they are in CR after a previously documented relapse (3rd or greater), but may have only received 3 or fewer cycles of chemotherapy to achieve the most current CR.\n* Cohort 4: Maintenance cohort: Patients in CR who are considered by treating physician to benefit from maintenance therapy are eligible for maintenance therapy with dexrazoxane combined with idarubicin plus cytarabine.\n\nExclusion Criteria:\n\n* Any condition, including the presence of laboratory abnormalities, which judged by the investigator, places the patient at unacceptable risk.\n* Active heart disease defined as: Unstable coronary syndromes, unstable or severe angina, recent myocardial infarction (MI) within 6 months.\n* Decompensated heart failure (HF).\n* Clinically significant arrhythmias.\n* Severe valvular disease.\n* History of coronary artery disease (CAD).\n* Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided.\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements per the judgment of the investigator.\n* Patient with documented hypersensitivity to any of the components of the chemotherapy program.\n* Men and women of childbearing potential who do not practice contraception.","12 Years",{"count":50,"type":19},100,[23],"This phase II trial studies how well dexrazoxane hydrochloride works in preventing heart-related side effects of chemotherapy in participants with blood cancers, such as acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia, and myeloproliferative neoplasms. Chemoprotective drugs, such as dexrazoxane hydrochloride, may protect the heart from the side effects of drugs used in chemotherapy, such as cladribine, idarubicin, cytarabine, and gemtuzumab ozogamicin, in participants with blood cancers.",[54,55,56,57,58,59,60],"Acute Myeloid Leukemia","Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Blasts 10 Percent or More of Bone Marrow Nucleated Cells","High Risk Myelodysplastic Syndrome","Myeloid Sarcoma","Myeloproliferative Neoplasm","Philadelphia Chromosome Positive","2026-05-19",{"date":63,"type":32},"2026-05-22",{"date":65,"type":32},"2018-09-19",{"date":67,"type":19},"2027-12-31",{"name":38,"class":39},1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":20,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":69},"100306003","phase-2-blinatumomab-methotrexate-cytarabine-and-ponatinib-in-treating-patients-with-philadelphia-chromosome-positive-or-bcr-abl-positive-or-relapsedrefractory-acute-lymphoblastic-leukemia-100306003","NCT03263572","Blinatumomab, Methotrexate, Cytarabine, and Ponatinib in Treating Patients With Philadelphia Chromosome-Positive, or BCR-ABL Positive, or Relapsed\u002FRefractory, Acute Lymphoblastic Leukemia","Phase II Study of the Combination of Blinatumomab and Ponatinib in Patients With Philadelphia Chromosome (Ph)-Positive and\u002For BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL)","Inclusion Criteria:\n\n1. Diagnosis of one of the following:\n\n   1. Participants ≥ 18 years of age with previously untreated Ph-positive ALL \\[either t(9;22) and\u002For BCR-ABL positive\\] (includes patients initiated on first course of therapy before cytogenetics known) or with lymphoid accelerated or blast phase CML. These participants could have received one or two courses of chemotherapy with or without other TKIs and still eligible. (Participants with lymphoid accelerated or blast phase CML will be evaluated separately) i. If they achieved CR, they are assessable only for event-free and overall survival, or ii. If they failed to achieve CR, they are assessable for CR, event-free, and overall survival\n   2. Participants ≥ 18 years of age with relapsed\u002Frefractory Ph-positive ALL or with previously treated lymphoid accelerated or blast phase CML (Participants with lymphoid accelerated or blast phase CML will be evaluated separately)\n   3. Participants ≥ 18 years of age with ALL MRD positive (either by NGS or PCR or flowcytometry) or with previously treated lymphoid accelerated or blast phase CML (Participants with lymphoid accelerated or blast phase CML will be evaluated separately)\n2. Performance status ≤ 2 (ECOG Scale)\n3. Adequate liver function as defined by the following criteria (unless the increased values are judged to be leukemia disease related):\n\n   1. Total serum bilirubin ≤ 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome\n   2. Alanine aminotransferase (ALT) ≤ 3 x ULN, OR\n   3. Aspartate aminotransferase (AST) ≤ 3 x ULN\n4. Adequate pancreatic function as defined by the following criteria:\n\n   a) Serum lipase and amylase ≤ 1.5 x ULN\n5. For females of childbearing potential, a negative urine pregnancy test must be documented\n6. Female participants who:\n\n   * Are postmenopausal for at least 1 year before the screening visit, OR\n   * Are surgically sterile, OR\n   * If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse\n7. Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:\n\n   * Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or\n   * Agree to completely abstain from heterosexual intercourse\n8. Adequate cardiac function as assessed clinically by history and physical examination.\n9. Signed informed consent\n\nExclusion Criteria:\n\n1. Active serious infection not controlled by oral or intravenous antibiotics.\n2. History of acute pancreatitis within 1 year of study or history of chronic pancreatitis\n3. History of alcohol abuse\n4. Uncontrolled hypertriglyceridemia (triglycerides \\> 650mg\u002FL)\n5. Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year.\n6. Active Grade III-V cardiac failure as defined by the New York Heart Association Criteria.\n7. Uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:\n\n   * Myocardial infarction (MI), stroke, or revascularization within 3 months\n   * Unstable angina or transient ischemic attack\n   * Congestive heart failure prior to enrollment, or left ventricular ejection fraction (LVEF) less than lower limit of normal per local institutional standards prior to enrollment\n   * Diagnosed or suspected congenital long QT syndrome\n   * Clinically significant atrial or ventricular arrhythmias (such as artrial fibrillation, ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) as determined by the treating physician\n   * Prolonged QTc interval on pre-entry electrocardiogram (\\> 470 msec) unless corrected after electrolyte replacement or approved by cardiologist\n   * Significant venous or arterial thromboembolism including deep venous thrombosis or pulmonary embolism. Participants with a history of treated prior superficial or catheter associated will not be considered as significant embolism and after discussion with PI will not be excluded from eligibility.\n   * Uncontrolled hypertension (diastolic blood pressure \\>90mmHg; systolic \\>140mmHg). Participants with hypertension should be under treatment on study entry to effect blood pressure control\n8. History or presence of clinically relevant CNS pathology or event such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis or severe (grade 3 or above) CNS events including ICANS from prior CART or other T cell engager therapies. Participants with active CNS leukemia - will NOT be excluded\n9. Current autoimmune disease or history of autoimmune disease with potential CNS involvement\n10. Treatment with any investigational antileukemic agents or chemotherapy agents within 2 weeks prior to study entry, unless full recovery from side effects has occurred or participant has rapidly progressive disease judged to be life-threatening by the investigator.\n11. Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.\n12. History of significant bleeding disorder unrelated to cancer, including:\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)\n13. Participants with documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia.\n14. Known active infection with HIV, HBV, HCV.",{"count":78,"type":19},90,[23],"This phase II trial studies how well blinatumomab, methotrexate, cytarabine, and ponatinib work in treating patients with Philadelphia chromosome (Ph)-positive, or BCR-ABL positive, or acute lymphoblastic leukemia that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as methotrexate and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving blinatumomab, methotrexate, cytarabine, and ponatinib may work better in treating patients with acute lymphoblastic leukemia.",[82,27,83,55,60,84,85,86],"Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","BCR-ABL1 Fusion Protein Expression","Recurrent Acute Lymphoblastic Leukemia","Refractory Acute Lymphoblastic Leukemia","t(9;22)","2026-05-18",{"date":89,"type":32},"2026-05-20",{"date":91,"type":32},"2017-11-29",{"date":93,"type":19},"2027-11-30",{"name":38,"class":39},{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":20,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":69},"100606696","phase-2-phase-ii-study-of-the-combination-of-subcutaneous-blinatumomab-and-olverembatinib-in-patients-with-philadelphia-chromosome-ph-positive-andor-bcrabl1-positive-acute-lymphoblastic-leukemia-all-100606696","NCT07178912","Phase II Study of the Combination of Subcutaneous Blinatumomab and Olverembatinib in Patients With Philadelphia Chromosome (ph)-Positive and\u002For BCR::ABL1 Positive Acute Lymphoblastic Leukemia (ALL)","Eligibility Criteria\n\n* Diagnosis of one of the following:\n\n  o Participants ≥18 years of age with newly diagnosed or relapsed\u002Frefractory Ph-positive and\u002For BCR::ABL1-positive ALL (includes Participants initiated on first course of therapy before cytogenetics known) or with lymphoid accelerated or blast phase CML. Participants with newly diagnosed disease could have received one or two courses of chemotherapy with or without other TKIs and still eligible (Participants with lymphoid accelerated or blast phase CML will be evaluated separately).\n* Performance status ≤2 (ECOG Scale).\n* Adequate liver function as defined by the following criteria (unless the increased values are judged to be leukemia disease related):\n\n  * Total serum bilirubin \\\u003C2 x upper limit of normal (ULN), unless due to Gilbert's syndrome\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C3 x ULN.\n* Adequate pancreatic function as defined by serum lipase and amylase \\\u003C1.5 x ULN.\n* For females of childbearing potential, a negative urine pregnancy test must be documented.\n* Female Participants who:\n\n  * Are postmenopausal for at least 1 year before the screening visit, OR\n  * Are surgically sterile, OR\n  * If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug or agree to completely abstain from heterosexual intercourse.\n* Male Participants, even if surgically sterilized (i.e., status post-vasectomy), who:\n\n  * Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, OR\n  * Agree to completely abstain from heterosexual intercourse.\n* Adequate cardiac function as assessed clinically by history and physical examination.\n* Signed informed consent.\n\nExclusion Criteria\n\n* Active serious infection not controlled by oral or IV antibiotics.\n* Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n\nActive grade III-V cardiac failure as defined by the New York Heart Association criteria.\n\n* Uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:\n\n  * Myocardial infarction, stroke, or revascularization within 3 months\n  * Unstable angina or transient ischemic attack\n  * Congestive heart failure prior to enrollment, or left ventricular ejection fraction less than lower limit of normal per local institutional standards prior to enrollment\n  * Diagnosed or suspected congenital long QT syndrome\n  * Clinically significant atrial or ventricular arrhythmias (such as atrial fibrillation, ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) as determined by the treating physician\n  * Prolonged QTc interval on pre-entry electrocardiogram (\\>470 msec) unless corrected after electrolyte replacement or approved by cardiologist\n  * Significant venous or arterial thromboembolism including deep venous thrombosis or pulmonary embolism. Participants with a history of treated prior superficial or catheter associated thrombosis will not be considered as significant embolism and after discussion with PI will not be excluded from eligibility\n  * Uncontrolled hypertension (diastolic blood pressure \\>90 mmHg, systolic \\>140 mmHg). Participants with hypertension should be under treatment on study entry for blood pressure control.\n* History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. Participants with active CNS leukemia will not be excluded.\n* Current autoimmune disease or history of autoimmune disease with potential CNS involvement.\n* Treatment with any investigational antileukemic agent or chemotherapy agent in the last 7 days before study entry, unless full recovery from side effects has occurred or Participant has rapidly progressive disease judged to be life-threatening by the investigator.\n* Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.\n* History of significant bleeding disorder unrelated to cancer, including:\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 documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia.",{"count":102,"type":19},60,[23],"To find out if giving blinatumomab as injections under the skin and olverembatinib can help to control the disease in patients with Ph-positive ALL.",[106,107,108,109,60],"Phase II Clinical Trial","Blinatumomab","Olverembatinib","Lymphoblastic Leukemia","NOT_YET_RECRUITING","2026-04-29",{"date":113,"type":32},"2026-05-05",{"date":115,"type":19},"2026-08-27",{"date":117,"type":19},"2033-09-30",{"name":38,"class":39},{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":20,"phases":128,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":69},"100439867","phase-2-astx727-and-dasatinib-for-the-treatment-of-newly-diagnosed-philadelphia-chromosome-or-bcr-abl-positive-chronic-myeloid-leukemia-in-chronic-phase-100439867","NCT05007873","ASTX727 and Dasatinib for the Treatment of Newly Diagnosed Philadelphia Chromosome or BCR-ABL Positive Chronic Myeloid Leukemia in Chronic Phase","Phase II Study Assessing Safety and Clinical Activity of the Combination of ASTX727 With Dasatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (CML-CP)","Inclusion Criteria:\n\n* Diagnosis of Philadelphia chromosome (Ph)-positive or BCR-ABL positive CML in early chronic phase CML (i.e., time from diagnosis ≤12 months). Except for hydroxyurea and\u002For 1 to 2 doses of cytarabine patients must have received no or minimal prior therapy, defined as \\\u003C 1 month (30 days) of prior Food and Drug Administration (FDA) approved tyrosine kinase inhibitor (TKI)\n\n  * Clonal evolution defined as the presence of additional chromosomal abnormalities other than the Ph chromosome has historically been included as a criterion for accelerated phase. However, patients with clonal evolution as the only criterion of accelerated phase have a significantly better prognosis, and when present at diagnosis may not impact the prognosis at all. Thus, patients with clonal evolution at diagnosis (early disease) and no other criteria for accelerated phase will be eligible for this study.\n* Eastern Cooperative Oncology Group (ECOG) performance of 0-2\n* Adequate end organ function, defined as the following: total bilirubin \\\u003C1.5x ULN (unless secondary to Gilbert's disease, in which case should be \\\u003C 2.5x ULN), SGPT \\\u003C3x ULN, creatinine clearance ≥ 30mL\u002Fmin calculated using modified Crokcroft-Gault.\n* Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.\n* Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment.\n\nExclusion Criteria:\n\n* New York Heart Association (NYHA) cardiac class 3-4 heart disease\n* Cardiac Symptoms: Patients 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 corrected QT (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* Patients with active, uncontrolled psychiatric disorders include: psychosis, major depression, and bipolar disorders\n* Subject is known to be positive for human immunodeficiency virus (HIV) (HIV testing is not required)\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. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface \\[HBs\\] antigen negative-, anti-HBs antibody positive and anti-hepatitis B core \\[HBc\\] antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate\n* Women of pregnancy potential must practice an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized. Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Women must continue birth control for the duration of the trial and at least 3 months after the last dose of study drug.\n\nPregnant or breast-feeding women are excluded.\n\nAll WOCBP must have a negative pregnancy test prior to first receiving investigational product. If the pregnancy test is positive, the patient must not receive study drug and must not be enrolled in the study\n\n* Patients 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\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    * Peripheral or marrow blasts 15% or more\n    * Peripheral or marrow basophils 20% or more\n    * Thrombocytopenia \\\u003C 100 x 10\\^9\u002FL unrelated to therapy\n    * Documented extramedullary blastic disease outside liver or spleen",{"count":127,"type":19},70,[23],"This phase II trial studies the effect of ASTX727 and dasatinib in treating patients with newly diagnosed Philadelphia chromosome or BCR-ABL positive chronic myeloid leukemia in chronic phase. Philadelphia chromosome positive and BCR-ABL positive are types of genetic mutations (changes). Chemotherapy drugs, such as ASTX727, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. ASTX727 and dasatinib may help to control Philadelphia chromosome-positive chronic myeloid leukemia or BCR-ABL positive chronic myeloid leukemia in chronic phase.",[131,60,132,133],"Chronic Phase Chronic Myelogenous Leukemia","BCR-ABL1 Positive Chronic Myelogenous Leukemia","BCR-ABL1 Positive","2026-02-17",{"date":136,"type":32},"2026-02-18",{"date":138,"type":32},"2021-10-21",{"date":140,"type":19},"2026-10-30",{"name":38,"class":39}]