RecruitingPhase 2NCT07512700

Venetoclax Combined With CACAG Regimen Versus "3+7" Regimen in the Treatment of Acute Monocytic Leukemia

Venetoclax Combined With CACAG Regimen Versus "3+7" Regimen in the Treatment of Acute Monocytic Leukemia: A Prospective, Randomized, Controlled Study

Sponsor

Chinese PLA General Hospital

Enrollment

204 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Monocytic Leukemia

Summary

This study is a multicenter, randomized, prospective Phase II clinical trial designed to compare the effectiveness of two treatment approaches for patients with acute monocytic leukemia.

Eligibility

Min Age: 14 YearsMax Age: 60 Years

Inclusion Criteria8

Voluntary participation with written informed consent signed by the participant or a legal guardian; willingness to comply with all study procedures.
Age 14 to 60 years at screening, no gender restriction.
Diagnosis of acute monocytic leukemia according to the 2016 WHO classification, excluding acute promyelocytic leukemia.
No history of severe allergic reactions.
Liver function: ALT and AST ≤ 2.5 × upper limit of normal (ULN); total bilirubin ≤ 2 × ULN.
Renal function: serum creatinine ≤ 1.5 × ULN
No uncontrolled infection or severe psychiatric disorder.
ECOG performance status 0-3; life expectancy ≥ 4 months.

Exclusion Criteria8

Known hypersensitivity or contraindication to any study drug.
Pregnancy or lactation.
Active infection.
Long-term smoking or alcohol abuse that may interfere with study outcome evaluation.
Psychiatric illness or other condition that prevents informed consent or compliance with study procedures.
Major organ surgery within 6 weeks prior to enrollment.
Abnormal liver function: total bilirubin > 2× ULN, ALT/AST > 2.5 × ULN; abnormal renal function: serum creatinine > 1.5 × ULN.
Any condition deemed unsuitable for the study by the investigator (e.g., poor compliance, substance abuse).

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Interventions

DRUGCACAG+VEN

Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor 1. Azacytidine (75 mg/m2/day, days 1 to 7). 2. Cytarabine (75-100 mg/m2 every 12 hrs, days 1 to 5). 3. Aclacinomycin (20 mg/day, days 1,3,5). 4. Chidamide (30 mg/day , days 1,4,8,11). 5. Venetoclax is administered orally with a dose ramp-up schedule: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3 through 14. If an azole antifungal agent is co-administered, the dose of venetoclax is reduced to 100 mg daily. 6.Granulocyte colony-stimulating factor (G-CSF) is given subcutaneously at 300 μg per day until neutrophil recovery.

DRUG3+7

IA regimen: 1. Idarubicin (8-10 mg/m2) for 3 days. 2.Cytarabine (75-100mg/m2, every 12 hrs) for 7 days. DA regimen: 1.Daunorubicin(60 mg/m2) for 3 days. 2.Cytarabine (75-100mg/m2, every 12 hrs) for 7 days. MA regimen: 1.Mitoxantrone (12 mg/m2) for 3 days. 2.Cytarabine (75-100mg/m2, every 12 hrs) for 7 days.