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Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
Sponsor: Chinese PLA General Hospital
Summary
The purpose of this study is to compare the efficacy and safety of venetoclax combined with CACAG regimen with BAT regimen in the treatment of relapsed/refractory acute myeloid leukemia.
Official title: A Prospective,Randomized,and Comparative Study on the Efficacy of Venetoclax Combined With CACAG Regimen and BAT Regimen in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
Key Details
Gender
All
Age Range
14 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2023-08-01
Completion Date
2030-01-31
Last Updated
2026-04-02
Healthy Volunteers
No
Interventions
Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor
1. Azacytidine (75mg/m2/day, days 1 to 7). 2. Cytarabine (75-100mg/m2 q12h, days 1 to 5). 3. Aclacinomycin(20mg/day, days 1,3,5). 4. Chidamide(30mg/day , days 1,4,8,11). 5. Venetoclax (100mg on day 1,200mg on day 2,400mg on days 3-14). 6. Granulocyte colony stimulating factor (300 μg/day, day 0 until agranulocytosis recovery)
Best-Available Therapy(BAT) Regimen
1. FLAG regimen:Fludarabine(30mg/m2,days 1-5)+Cytarabine (1-2g/m2 applied 4h after fludarabine, days 1 to 5)+Granulocyte colony-stimulating factor(300ug/day,days 0 to 5) 2. CLAG regimen:Cladribine(5mg/2,days 1-5)+Cytarabine (1-2g/m2 applied 4h after fludarabine, days 1 to 5)+Granulocyte colony-stimulating factor(300ug/day,days 0 to 5) 3. MAE regimen:Mitox(10mg/m2,days 1 to 5)+VP-16(100mg/m2,days 1 to 5)+Cytarabine (100-150mg/m2,days 1 to 7) 4. DCAG regimen:Decitabine(20mg/m2,days 1 to 5)+Aclacinomycin(20mg/day on days 1,3,5)+Cytarabine (100mg q12h,days 1 to 5)+Granulocyte colony-stimulating factor(300 ug/day,day 0 until agranulocytosi recovery) 5. HAA regimen:HHT(2mg/m2,days 1 to 7)+Aclacinomycin(20mg/day,days 1 to 7) and Cytarabine (100-200 mg/m2, days 1 to 5); 6. HAD regimen:HHT(2mg/m2,days 1 to 7)+Daunorubicin(45mg/m2/day,days 1 to 3)+Cytarabine (100-200 mg/m2,days 1 to 5).
Locations (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, China