[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-chronic-myelogenous-leukemia-bcr-abl1-positive\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-chronic-myelogenous-leukemia-bcr-abl1-positive":36},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100218005","phase-2-cladribine-idarubicin-cytarabine-and-venetoclax-in-treating-patients-with-acute-myeloid-leukemia-high-risk-myelodysplastic-syndrome-or-blastic-phase-chronic-myeloid-leukemia-100218005",false,"NCT02115295","Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia","Phase II Study of Cladribine Plus Idarubicin Plus Cytarabine (ARAC) in Patients With AML, HR MDS, or Myeloid Blast Phase of CML","Inclusion Criteria:\n\n1. Patients with a diagnosis of AML, Acute Biphenotypic Leukemia, or high risk MDS (\\>\u002F= 10% blasts or IPSS \\>\u002F= intermediate-2) will be eligible. Patients with CML in Myeloid Blast Phase are also eligible.\n2. For Frontline cohort (1 or 4): No prior potentially-curative therapy for leukemia. Prior therapy with hydroxyurea, hematopoietic growth factors, azacytidine, decitabine, ATRA, or a total dose of cytarabine up to 2g (for emergency use for stabilization) is allowed. Patients deemed able to receive venetoclax (ie. insurance clearance) will be assigned to Frontline cohort 4. Patients with secondary AMLwho have been treated for their antecedent myeloid neoplasm will be enrolled into the separate Secondary AML cohort.\n3. For Salvage cohort: Patients with previously treated, relapsed or refractory AML, Acute Biphenotypic Leukemia, or CML in Myeloid Blast Phase are eligible.\n4. Age \\\u003C\u002F= 65 years.\n5. Adequate organ function as defined below:\n\n   * liver function (bilirubin \\\u003C 2mg\u002FdL, AST and\u002For ALT \\\u003C3 x ULN - or \\\u003C5 x ULN if related to leukemic involvement)\n   * kidney function (creatinine \\\u003C 1.5 x ULN ).\n   * known cardiac ejection fraction of \\> or = 45% within the past 6 months\n6. ECOG performance status of ≤ 2.\n7. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.\n8. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient is required prior to their enrollment on the protocol.\n\nExclusion Criteria:\n\n1. 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.\n2. Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n3. Patient with documented hypersensitivity to any of the components of the chemotherapy program.\n4. Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.","ALL","18 Years","65 Years",{"count":20,"type":21},508,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This phase II trial studies how well cladribine, idarubicin, cytarabine, and venetoclax work in patients with acute myeloid leukemia, high-risk myelodysplastic syndrome, or blastic phase chronic myeloid leukemia. Drugs used in chemotherapy, such as cladribine, idarubicin, cytarabine, and venetoclax, 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.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40],"Acute Biphenotypic Leukemia","Acute Myeloid Leukemia","Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Blasts 10 Percent or More of Bone Marrow Nucleated Cells","Blasts 10 Percent or More of Peripheral Blood White Cells","de Novo Myelodysplastic Syndrome","Myelodysplastic Syndrome","Previously Treated Myelodysplastic Syndrome","Recurrent Acute Myeloid Leukemia","Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Refractory Acute Myeloid Leukemia","Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Secondary Acute Myeloid Leukemia","Untreated Adult Acute Myeloid Leukemia","RECRUITING","2026-05-18",{"date":44,"type":45},"2026-05-20","ACTUAL",{"date":47,"type":45},"2014-05-19",{"date":49,"type":21},"2030-05-31",{"name":51,"class":52},"M.D. Anderson Cancer Center","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":53},"100189832","phase-2-ponatinib-hydrochloride-as-second-line-therapy-in-treating-patients-with-chronic-myeloid-leukemia-in-chronic-phase-resistant-or-intolerant-to-imatinib-mesylate-dasatinib-or-nilotinib-100189832","NCT01746836","Ponatinib Hydrochloride as Second Line Therapy in Treating Patients With Chronic Myeloid Leukemia in Chronic Phase Resistant or Intolerant to Imatinib Mesylate, Dasatinib, or Nilotinib","Ponatinib as Second Line Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase Resistant or Intolerant to Imatinib, Dasatinib or Nilotinib","Inclusion Criteria:\n\n* Diagnosis of Philadelphia chromosome (Ph)-positive (by cytogenetics or fluorescent in situ hybridization \\[FISH\\]) or breakpoint cluster region (BCR)-ABL-positive (by polymerase chain reaction \\[PCR\\]) CML in chronic phase.\n* Participants should have demonstrated to have failure to therapy to one FDA-approved second-generation TKI (currently bosutinib, dasatinib, and nilotinib are approved as frontline therapy), defined as per European leukemiaNet (ELN)35 or National Comprehensive Cancer Network (NCCN) recommendations:\n\n  * Less than complete hematologic response (CHR) at or beyond 3 months\n  * No partial cytogenetic response at or beyond 3 months\n  * BCR-ABL1 ≥ 10% at or beyond 3 months\n  * BCR-ABL1 ≥ 1% at or beyond 6 months\n* Loss of CCyR or development of mutations or other clonal chromosomal abnormalities at any time during TKI treatment\n* Age \\>18 years\n* ECOG performance of 0-2.\n* Adequate end organ function, defined as the following: total bilirubin ≤1.5x ULN (unless due to Gilbert syndrome, in which case it should be ≤3.0x ULN), SGPT ≤2.5x ULN, creatinine clearance (CrCL) ≥ 30 mL\u002Fmin (Cockcroft-Gault formula).\n* Participants 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* 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:\n* 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.\n* Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential OR women who are surgically sterile.\n* 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* Women and men must continue birth control for the duration of the trial and at least 3 months after the last dose of study drug.\n* All WOCBP MUST have a negative pregnancy test prior to first receiving investigational product.\n* Participants should have discontinued therapy with bosutinib, dasatinib or nilotinib or other anti-leukemia therapy (except hydroxyurea), at least 48 hours prior to start of study therapy and recovered from any toxicity due to these therapies to at least grade 1. The use of hydroxyurea is allowed immediately prior to study entry.\n\nExclusion Criteria:\n\n* Prior therapy with other BCR-ABL-targeted TKIs except bosutinib, dasatinib or nilotinib. Participants with T315I mutations are eligible and will be analyzed separately.\n* Active NYHA cardiac class 3-4 heart disease\n* Have clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:\n\n  * Any history of MI, unstable angina, cerebrovascular accident, or TIA\n  * Any history of peripheral vascular infarction, including visceral infarction\n  * Any revascularization procedure, including the placement of a stent\n  * 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  * History of clinically significant (as determined by the treating physician) atrial arrhythmia or any history of ventricular arrhythmia\n  * Venous thromboembolism, including deep venous thrombosis or pulmonary embolism, within 6 months prior to enrollment\n* Participants with active, uncontrolled psychiatric disorders including: psychosis, major depression, and bipolar disorders.\n* Have uncontrolled hypertension (i.e., \\>150 and \\>90 for SBP and DBP, respectively). Participants with hypertension should be under treatment at study entry to ensure blood pressure control. Those requiring 3 or more antihypertensive medications should be discussed with the PI.\n* Have poorly controlled diabetes defined as HbA1c values of \\> 7.5%. Participants with preexisting, well-controlled, diabetes are not excluded.\n* Pregnant or breast-feeding women are excluded.\n* Participants with history of pancreatitis within 1 year of study or history of chronic pancreatitis.\n* Participants in accelerated or blast phase, or patients who have ever been documented to be in blast phase CML, are excluded.\n\nThe definitions of excluded CML phases are as follows:\n\n1. Blastic phase: presence of 30% blasts or more in the peripheral blood or bone marrow.\n2. 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 109\u002FL unrelated to therapy\n   * Documented extramedullary blastic disease outside liver or spleen\n3. Clonal evolution defined as the presence of additional chromosomal abnormalities other than the Ph chromosome has been historically been included as a criterion for accelerated phase. However, participants with clonal evolution as the only criterion of accelerated phase have a significantly better prognosis. Thus, participants with clonal evolution and no other criteria for accelerated phase will be eligible for this study, but analyzed separately.\n\n   * Participants who have received more than one FDA-approved TKI for CML, or any investigational, non-FDA approved TKI.",{"count":62,"type":21},50,[24],"This phase II trial studies how well ponatinib hydrochloride works as second line therapy in treating patients with chronic myeloid leukemia in chronic phase that has not responded to initial treatment (first line) with imatinib mesylate, dasatinib, or nilotinib or cannot tolerate imatinib mesylate, dasatinib, or nilotinib. Ponatinib hydrochloride may stop or control the growth of cancer cells by blocking a protein needed for cell growth.",[66,67,36],"Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Philadelphia Chromosome Positive, BCR-ABL1 Positive Chronic Myelogenous Leukemia","2026-03-05",{"date":70,"type":45},"2026-03-09",{"date":72,"type":45},"2013-01-17",{"date":74,"type":21},"2030-12-31",{"name":51,"class":52},{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":53},"100334179","phase-1-edetate-calcium-disodium-or-succimer-in-treating-patients-with-acute-myeloid-leukemia-or-myelodysplastic-syndrome-undergoing-chemotherapy-100334179","NCT03630991","Edetate Calcium Disodium or Succimer in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Chemotherapy","Monitoring, Detoxifying, and Rebalancing Metals During Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Therapy","Inclusion Criteria:\n\n* Patients ≥18 years of age, or their legally authorized representative (LAR), must have the ability to understand the requirements of the study and must voluntarily sign the informed consent form. For patients \\\u003C18 years of age, a parent or LAR must have the ability to understand the requirements of the study and must voluntarily sign the informed consent form. Any required verbal assent and\u002For signed assent of minor must be obtained for participants \\\u003C18 years.\n* Age ≥18 years at the time of signing the informed consent form.\n* Age ≥1 years and \\\u003C18 years with weight requirement ≥8 kg at the time of the signing of the informed consent form (e.g. by parent or LAR)\n* Patients enrolling in the pediatric\u002Fadolescent\u002Fyoung adult exploratory cohort must be:\n\nAge ≥ 1 years and \\\u003C18 years with weight requirement ≥8 kg at the time of the signing of the informed consent form (e.g. by parent or LAR), Or age 18 years -39 years at the time of the signing of the informed consent form\n\n* Diagnosis of any of the following:\n* Newly diagnosed (or untreated) AML with intermediate-risk\u002Fpoor-risk cytogenetics, intermediate-risk\u002Fpoor-risk molecular, or secondary AML (i.e. therapy-related or evolved from antecedent hematologic malignancy)\n* Newly diagnosed (or untreated) myeloid blast phase of myeloproliferative neoplasm (MPN) (including myeloid blast phase of chronic myeloid leukemia \\[CML\\])\n* Newly diagnosed (or untreated) high-risk, very-high risk or secondary MDS\u002Fmyeloid neoplasm\n* Newly diagnosed (or untreated) MDS\u002FMPN (regardless of cytogenetic\u002Fmolecular status)\n* Relapsed and\u002For refractory AML, MDS\u002Fmyeloid neoplasm , MDS\u002FMPN, myeloid blast phase of MPN (including myeloid blast phase of CML)\n* Patients enrolling in the childhood\u002Fadolescent\u002Fyoung adult exploratory cohort may have any of the following diagnoses:\n* High-risk or relapsed\u002Frefractory childhood, adolescent, or young adult malignancies including but not limited to high-risk or relapsed\u002Frefractory ALL or other high-risk or relapsed refractory malignancies\n* This includes, but is not limited to, the following: High-risk ALL\u002FLL including T-ALL\u002FLL, Ph-like ALL\u002FLL, Ph+ B-ALL\u002FLL, B-ALL\u002FLL with CNS lymphoid leukemic involvement, testicular involvement, other extramedullary involvement by ALL\u002FLL; ALL\u002FLL with any of the NCI high-risk features: patients aged 10 years or older and those with a white blood cell count ≥50 × 109 per L), high-risk cytogenetics (MLL rearrangements, near haploidy \\[\\\u003C30 chromosomes\\], low hypodiploidy \\[30-39 chromosomes\\], t\\[17;19\\]\\[q23;p13\\], intrachromosomal amplification of chromosome 21), Burkitts'; Burkitt's-like, Double-Hitt; CNS involvement by any non-primary brain malignancy; Metastatic disease of any malignancy; 5-year survival prognosis of less than 50%, based on the treating physician's assessment\n* Patients on non-investigational regimens or on IND-exempt MD Anderson studies (for hematologic malignancies) of approved drugs are also eligible.\n* Patients on IND studies (for hematologic malignancies) utilizing FDA approved commercially available drugs are eligible.\n* Investigational agents that are not used for treatment of the leukemia per se (e.g. anti-infective prophylaxis or therapy) will be allowed. Other supportive care studies are allowed, even if under an IND.\n* Newly diagnosed MDS or AML, as well as MDS\u002FMPN, myeloid blast phase of MPN (including myeloid blast phase of CML), patients can enroll on this study after start of non-investigational induction therapy, but must be within first 3 cycles of therapy of front-line therapy. Patients with relapsed and\u002For refractory AML, MDS, MDS\u002FMPN, myeloid blast phase of MPN (including myeloid blast phase of CML) can enroll. Newly diagnosed patients enrolling in the exploratory cohort with high-risk malignancies can enroll after the start of non-investigational therapy but must be within first 3 cycles of front-line therapy.\n* Transformed and untreated AML transformed from previously treated MDS, myeloproliferative neoplasm (MPN) or other types of secondary AML are allowed. Myeloid-Blast Phase of MPN and Chronic Myeloid Leukemia (CML) are allowed.\n* Eastern Cooperative Oncology Group (ECOG) performance status of =\\\u003C 3 or Lansky or Karnofsky ≥ 30 at study entry; patients who are unable to walk, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n* Laboratory test results within these ranges (unless due to leukemia or other hematologic malignancy):\n* Serum creatinine =\\\u003C 1.5 mg\u002FdL\n* Total Bilirubin =\\\u003C 2.0 x upper limit of normal (ULN), unless the patient has Gilbert's\n* AST (SGOT) and\u002For ALT (SGPT) =\\\u003C 2.0 x ULN\n* Women of childbearing potential (WCBP) must have a negative urine pregnancy test within 7 days and must either commit to continued abstinence from heterosexual intercourse or adopting at least one highly effective method of contraception. These methods include intra-uterine device, tubal ligation, partner's vasectomy, and hormonal birth control pills. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential\n* Extramedullary disease is allowed as long as it can be measured and followed for response.\n\nNote: Patients can be considered MDS by either WHO or FAB150 criteria Note: MDS risk status assessment is based on IPSS-R and\u002For IPSS-M. AML risk status assessment is based on ELN and World Health Organization classification\n\nExclusion Criteria:\n\n* Nursing and pregnant females. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\n* Uncontrolled inter-current illness including, but not limited to, uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or which judged by the investigator, places the patient at unacceptable risk\n* Acute Promyelocytic leukemia (APL)","1 Year",{"count":85,"type":21},58,[87],"PHASE1","This phase I trial studies the side effects and best dose of edetate calcium disodium or succimer in treating patients with acute myeloid leukemia or myelodysplastic syndrome undergoing chemotherapy. Edetate calcium disodium or succimer may help to lower the level of metals found in the bone marrow and blood and may help to control the disease and\u002For improve response to chemotherapy.",[28,90,29,91,92,33,93,94,35,36,95,96,37,38,97,39,98,99],"Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome","Chronic Myelogenous Leukemia, BCR-ABL1 Positive","High Risk Myelodysplastic Syndrome","Myelodysplastic\u002FMyeloproliferative Neoplasm","Myeloproliferative Neoplasm","Recurrent Myelodysplastic Syndrome","Recurrent Myelodysplastic\u002FMyeloproliferative Neoplasm","Refractory Myelodysplastic Syndrome","Secondary Myelodysplastic Syndrome","Very High Risk Myelodysplastic Syndrome","2026-02-26",{"date":102,"type":45},"2026-03-02",{"date":104,"type":45},"2018-10-11",{"date":106,"type":21},"2027-04-30",{"name":51,"class":52}]