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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Voluntary participation with written willing to sign a consent form 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. - You should be able to carry out daily activities with 0 level of ability (ECOG 0)-3; life expectancy ≥ 4 months. Who Should NOT Join This Trial: - 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 willing to sign a consent form 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). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Criteria: * 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).

Treatments Being Tested

DRUG

CACAG+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.

DRUG

3+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.

Locations (3)

Air Force Medical Center, PLA
Beijing, China
Chinese PLA General Hospital
Beijing, China
PLA Strategic Support Force's Characteristic Medical Center
Beijing, China