Venetoclax Plus CACAG Regimen for Newly Diagnosed Acute Myeloid Leukemia

Sponsor
Chinese PLA General Hospital
Study ID
NCT06068621
Phase
PHASE2
Status
Completed

Conditions

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 (75 mg/m2/day, days 1 to 7). 2. Cytarabine (75-100 mg/m2 bid, 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 (400 mg/day, days 1 to 14,Combined with posaconazole reduced to 100 mg/day,Combined with voriconazole reduced to 200 mg/day ). 6. Granulocyte colony-stimulating factor (300 μg/day, day 0 until agranulocytosis recovery)
  • "3+7" — DRUG
    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.

Study Details

The purpose of this study is to compare the efficacy and safety of venetoclax combined with CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed acute myeloid leukemia.

Key Dates

Start date
Mar 1, 2023
Status verified
Jan 2026
Primary completion
May 31, 2024
Completion
Aug 31, 2025

Study Design

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

Arms

  • Experimental: Venetoclax Combined With CACAG Regimen
    Venetoclax combined with CACAG regimen for newly diagnosed 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;Combined with posaconazole, reduced to 100 mg/day;Combined with voriconazole, reduced to 200 mg/day.Granulocyte colony-stimulating factor was used as 300 μg/day from day 0 until agranulocytosi recovery .
  • Active Comparator: "3+7" Regimen
    Idarubicin+cytarabine(IA) regimen or daunorubicin+cytarabine(DA) regimen for newly diagnosed AML.Recipients were randomized and those entering this group received IA or DA induction chemotherapy. With the IA regimen,recipients received idarubicin(8-10 mg/m2) for three days and cytarabine(75-100 mg/m2, every 12 hrs) for seven days. With the DA regimen,recipients received daunorubicin(60 mg/m2)for three days and cytarabine(75-100 mg/m2,every 12 hrs)for seven days.

Primary Outcome Measure

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

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