OncoMatch/Clinical Trials/NCT04628026
Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2
Is NCT04628026 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Venetoclax and Standard chemotherapy for acute myeloid leukemia.
Treatment: Venetoclax · Standard chemotherapy — A Randomized, Placebo-Controlled Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome With Excess Blasts-2
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy
Exception: hydroxyurea for up to 14 days during diagnostic screening phase for leukocytosis; prior ESA or HMA for antecedent MDS allowed if stopped ≥4 weeks before study
No prior chemotherapy for AML, except hydroxyurea for up to 14 days during the diagnostic screening phase for the control of peripheral leukemic blasts in patients with leukocytosis (e.g., white blood cell [WBC] counts > 25x109/L); patients may have had previous treatment with erythroid stimulating agents (ESA) or hypomethylating agents (HMAs) for an antecedent phase of MDS; ESA and HMAs have to be stopped at least four weeks before start of study treatment.
Lab requirements
Kidney function
serum creatinine ≤ 2.0 × ULN or creatinine clearance >40 mL/min based on Cockcroft-Gault GFR
Liver function
Serum total bilirubin ≤ 2.5 × ULN unless considered due to Gilbert's disease, or leukemic involvement following approval; AST, ALT, ALP ≤ 3.0 × ULN unless considered due to leukemic involvement following approval
Adequate renal function as evidenced by serum creatinine ≤ 2.0 × ULN or creatinine clearance >40 mL/min based on the Cockcroft-Gault glomerular filtration rate (GFR). Adequate hepatic function as evidenced by: Serum total bilirubin ≤ 2.5 × ULN unless considered due to Gilbert's disease, or leukemic involvement following approval by the Principal Investigators or Trial Coordinators of the study; AST, ALT, ALP ≤ 3.0 × ULN, unless considered due to leukemic involvement following approval by the Principal Investigators or Trial Coordinators.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify