Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

Sponsor
Chinese PLA General Hospital
Study ID
NCT06084819
Phase
PHASE2
Status
Recruiting
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Conditions

  • Relapsed/Refractory Acute Myeloid Leukemia

Eligibility Criteria

Sex
ALL
Age
14 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor — DRUG
    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 — DRUG
    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).

Study Details

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.

Key Dates

Start date
Aug 1, 2023
Status verified
Mar 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax Combined With CACAG Regimen
    Venetoclax combined with CACAG regimen for relapsed/refractory AML. Recipients were randomized and those entering the experimental group received azacytidine,cytarabine,aclacinomycin,chidamide,venetoclax and granulocyte colony-stimulating factor. Azacytidine was used as 75 mg/m2/day from day 1 to day 7.Cytarabine was used as 75-100 mg/m2 bid from day 1 to day 5. Aclacinomycin was used as 20 mg/day on days 1,3,5. Chidamide was used as 30 mg/day on days 1,4,8,11. Venetoclax was used as 400 mg/day from day 1 to day 14.Granulocyte colony-stimulating factor was used as 300 ug/day from day 0 until agranulocytosi recovery.
  • Active Comparator: Best-Available Therapy(BAT) Regimen
    BAT regimen for relapsed/refractory AML.Recipients were randomized and those entering this group received FLAG/CLAG/MAE/DCAG/HAA/HAD regimen.

Primary Outcome Measure

Overall Response Rate (ORR) after 1 course of treatment [ Time Frame: 1 months after the start of study treatment ]

Central Contacts

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