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OncoMatch/Clinical Trials/NCT05805098

Venetoclax Combined With Homoharringtonine and Cytarabine in Induction for AML

Is NCT05805098 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including Venetoclax and Homoharringtonine for acute myeloid leukemia.

Phase 2/3RecruitingThe First Affiliated Hospital of Soochow UniversityNCT05805098Data as of May 2026

Treatment: Venetoclax · Homoharringtonine · CytarabineThis study aims to evaluate the efficacy and safety of venetoclax combined with homoharringtonine and cytarabine in the treatment of newly diagnosed acute myeloid leukemia.

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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

Lab requirements

Blood counts

White blood cell (WBC) count < 25 × 10^9 /L (hydroxyurea is permitted to meet this criterion)

Kidney function

Creatinine clearance ≥ 45 mL/min calculated by the Cockcroft Gault formula or measured by 24-hour urine collection; Creatinine clearance < 45 mL/min [excluded]

Liver function

Serum aspartate aminotransferase (AST) ≤ 3.0 × ULN, Serum alanine aminotransferase (ALT) ≤ 3.0 × ULN (unless considered due to leukemic organ involvement), Total bilirubin ≤ 1.5 × ULN, Moderate hepatic impairment with total bilirubin > 1.5 × ULN [excluded]

Cardiac function

Cardiac history of congestive heart failure requiring treatment or ejection fraction ≤ 50% or chronic stable angina [excluded]

Cardiac history of congestive heart failure requiring treatment or ejection fraction ≤ 50% or chronic stable angina. Diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume during the first second (FEV1) ≤ 65%. Creatinine clearance < 45 mL/min. Moderate hepatic impairment with total bilirubin > 1.5 × ULN. Laboratory values: Creatinine clearance ≥ 45 mL/min, AST ≤ 3.0 × ULN, ALT ≤ 3.0 × ULN (unless considered due to leukemic organ involvement), Total bilirubin ≤ 1.5 × ULN, WBC count < 25 × 10^9 /L (hydroxyurea is permitted to meet this criterion)

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

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