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Venetoclax Combined With CACAG Regimen Versus "3+7" Regimen in the Treatment of Acute Monocytic Leukemia
Sponsor: Chinese PLA General Hospital
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.
Official title: Venetoclax Combined With CACAG Regimen Versus "3+7" Regimen in the Treatment of Acute Monocytic Leukemia: A Prospective, Randomized, Controlled Study
Key Details
Gender
All
Age Range
14 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
204
Start Date
2025-09-01
Completion Date
2029-10-31
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
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.
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