OncoMatch/Clinical Trials/NCT03214562
Venetoclax With Combination Chemotherapy in Treating Patients With Newly Diagnosed or Relapsed or Refractory Acute Myeloid Leukemia
Is NCT03214562 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments for high risk myelodysplastic syndrome.
Treatment: Cytarabine · Filgrastim · Fludarabine · Idarubicin · Pegfilgrastim · Venetoclax — This phase Ib/II trial studies the best dose and side effects of venetoclax and how well it works when given with combination chemotherapy in treating patients with newly diagnosed acute myeloid leukemia or acute myeloid leukemia that has come back or does not respond to treatment. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine, cytarabine, filgrastim and idarubicin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with combination chemotherapy may work better in treating patients with acute myeloid leukemia.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Other
Cancer type
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Biomarker criteria
Excluded: PML t(15;17) karyotypic abnormality
Patients with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (French-American-British [FAB] class M3-AML)
Excluded: RARA t(15;17) karyotypic abnormality
Patients with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (French-American-British [FAB] class M3-AML)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: AML-directed therapy — relapsed, refractory, or intolerant (Part 1 only)
Only patients who are relapsed, refractory, or intolerant of standard AML therapy will be eligible for Part 1 (minimum of 1 prior line of AML-directed therapy)
Cannot have received: BCL2 inhibitor
Patients having received any prior BCL2 inhibitor therapy
Lab requirements
Kidney function
Creatinine clearance >= 30 mL/min based on the Cockcroft-Gault equation
Liver function
Total bilirubin < 1.5 x ULN unless increase is due to Gilbert's disease or leukemic involvement; AST and/or ALT < 3 x ULN unless considered due to leukemic involvement
Cardiac function
No NYHA class III or IV congestive heart failure; LVEF >= 40% by echocardiogram or MUGA; no history of myocardial infarction within the last 6 months or unstable/uncontrolled angina or severe/uncontrolled ventricular arrhythmias
Creatinine clearance >= 30 mL/min based on the Cockcroft-Gault equation; Total bilirubin < 1.5 x ULN unless increase is due to Gilbert's disease or leukemic involvement; AST and/or ALT < 3 x ULN unless considered due to leukemic involvement; Patients with NYHA class III or IV congestive heart failure or LVEF < 40% by echocardiogram or MUGA scan; history of myocardial infarction within the last 6 months or unstable/uncontrolled angina pectoris or history of severe and/or uncontrolled ventricular arrhythmias
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT03214562 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior BCL2 inhibitor disqualifies patients from enrollment.
Are patients with PML alterations eligible?
No. PML t(15;17) karyotypic abnormality is an exclusion criterion.
Are patients with RARA alterations eligible?
No. RARA t(15;17) karyotypic abnormality is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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