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OncoMatch/Clinical Trials/NCT05939180

VA vs DA for Newly Diagnosed Hig-risk AML

Is NCT05939180 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including Venetoclax Oral Tablet and Daunorubicin for acute myeloid leukemia.

Phase 2/3RecruitingThe First Affiliated Hospital of Soochow UniversityNCT05939180Data as of May 2026

Treatment: Venetoclax Oral Tablet · Daunorubicin — This is an open-label, multicenter, phase 2b, randomized study aiming to compare the efficacy and safety of venetoclax plus azacytidine Versus daunorubicin plus cytarabine (conventional 7+3 regimen) in adult acute myeloid leukemia (AML) patients with adverse risk featuress. Participants will be 1:1 randomly assigned to the VA and DA groups. Once remission was achieved, consolidated chemotherapy will be performed and allogeneic hematopoietic stem cell transplantation is strongly recommended. After completion of the study intervention, participants will be followed-up every 1 to 2 months for up to 2 years.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: hypomethylating agent

AML secondary to MDS and previously been treated with hypomethylating agents

Lab requirements

Kidney function

Ccr (Creatinine Clearance Rate) ≥30 ml/min

Liver function

Total bilirubin ≤ 1.5×ULN; AST ≤3×ULN (liver infiltration of leukemia: ≤5×ULN); ALT≤3×ULN (liver infiltration of leukemia: ≤5×ULN)

Cardiac function

No heart failure (grade 3-4)

Adequate liver function: Total bilirubin ≤ 1.5×ULN; aspartate aminotransferase (AST) ≤3×ULN (liver infiltration of leukemia: ≤5×ULN); alanine aminotransferase (ALT)≤3×ULN (liver infiltration of leukemia: ≤5×ULN). Adequate Renal function: Ccr (Creatinine Clearance Rate) ≥30 ml/min. Patients with heart failure (grade 3-4) [excluded].

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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