[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"untreated-adult-acute-myeloid-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:untreated-adult-acute-myeloid-leukemia":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"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":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":53},"100117950","phase-2-fludarabine-phosphate-cytarabine-filgrastim-sndz-gemtuzumab-ozogamicin-and-idarubicin-hydrochloride-in-treating-patients-with-newly-diagnosed-acute-myeloid-leukemia-or-high-risk-myelodysplastic-syndrome-100117950","NCT00801489","Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome","A Phase 2 Study of Fludarabine, Cytarabine, Filgrastim-sndz,Gemtuzumab Ozogamicin and Idarubicin in Newly Diagnosed Core Binding Factor Associated Acute Myelogenous Leukemia","Inclusion Criteria:\n\n* Patients must have untreated AML, or high-risk myelodysplastic syndromes (MDS) (refractory anemia with excess blasts, \\[RAEB\\], or RAEB \"in transformation\" \\[RAEB-t\\]) characterized by t(8;21), inv(16), or t(16;16); the presence of additional abnormalities is irrelevant\n* Patients must provide written consent\n* Participants will not be excluded based on performance status; for patients with Eastern Cooperative Oncology Group (ECOG) performance status \\>= to 3 the dosing schedule will be discussed with study chairman\n* Patients with organ dysfunction will not be excluded from the study; for patients with evidence of organ dysfunction (creatinine \\>= 1.5, cardiac ejection fraction =\\\u003C 50%, total bilirubin \\>=2 and aspartate aminotransferase \\[AST\\]\u002Falanine aminotransferase \\[ALT\\] \\>= 3 times upper limit of normal \\[ULN\\]), dose adjustments\u002Fomissions will be made\n* Up to one cycle of prior induction therapy will be permitted to include patients in whom presence of \"good-risk\" cytogenetics was initially missed; if the patient is in remission from induction therapy, he\u002Fshe will receive post-remission therapy; if the patient is not in remission then he\u002Fshe will receive induction therapy\n* Patients of child bearing potential should practice effective methods of contraception\n\nExclusion Criteria:\n\n* Pregnant and lactating females will be excluded",{"count":62,"type":21},270,[24],"This phase II trial studies the side effects and how well fludarabine phosphate, cytarabine, filgrastim-sndz, gemtuzumab ozogamicin, and idarubicin hydrochloride work in treating patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. Drugs used in chemotherapy, such as fludarabine phosphate, cytarabine, and idarubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to a antitumor drug, called calicheamicin. Gemtuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD33 receptors, and delivers calicheamicin to kill them. Colony-stimulating factors, such as filgrastim-sndz, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving fludarabine phosphate, cytarabine, filgrastim-sndz, gemtuzumab ozogamicin, and idarubicin hydrochloride may kill more cancer cells.",[66,67,68,32,69,70,71,72,73,40],"Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11","Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11","Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1","High Risk Myelodysplastic Syndrome","Inv(16)","Myelodysplastic Syndrome With Excess Blasts","t(16;16)","t(8;21)","2026-03-24",{"date":76,"type":45},"2026-03-30",{"date":78,"type":45},"2007-04-04",{"date":80,"type":21},"2028-10-11",{"name":51,"class":52}]