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A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients
Sponsor: Chinese PLA General Hospital
Summary
The purpose of this study is to compare the efficacy and safety of venetoclax combined with the CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed intermediate- or high-risk acute myeloid leukemia (AML).
Official title: A Multicenter, Prospective, Randomized Controlled Study of the Standard "3+7" Regimen Versus Venetoclax Combined With CACAG Regimen in Newly Diagnosed Adult Patients With Intermediate- and High-risk Acute Myeloid Leukemia
Key Details
Gender
All
Age Range
14 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2024-04-18
Completion Date
2026-09-01
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor
Azacytidine (75 mg/m2/day, days 1 to 7). Cytarabine (75-100 mg/m2 bid, days 1 to 5). Aclacinomycin(20 mg/day, days 1,3,5). Chidamide (30 mg/day , days 1,4,8,11). Venetoclax (400 mg/day, days 1 to 14,Combined with posaconazole reduced to 100 mg/day,Combined with voriconazole reduced to 200 mg/day ). Granulocyte colony-stimulating factor (300 μg/day, day 0 until agranulocytosis recovery)
"3+7"
IA regimen: Idarubicin (8-10 mg/m2) for 3 days . Cytarabine (75-100mg/m2, every 12 hrs) for 7 days. DA regimen: Daunorubicin(60 mg/m2) for 3 days. Cytarabine (75-100mg/m2, every 12 hrs) for 7 days.
Locations (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, China