Venetoclax Combined With Azacitidine and CAG in Refractory/Relapse Acute Myeloid Leukemia

Sponsor
Hematology department of the 920th hospital
Study ID
NCT05807347
Phase
PHASE2
Status
Unknown

Conditions

  • Refractory/Relapse Acute Myeloid Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    VA regimen Drug: Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-21); Drug: Azacitidine 75 mg/m2 subcutaneously once daily on days 1-7. CAG regimen Drug: Cytarabine 10mg/m2 subcutaneously q12h on days 1-7 Drug: Aclacinomycin 12-14mg/m2 on days 1,3,5,7 Drug: Granulocyte colony-stimulating factor 5ug/kg on days 0-8, discontinue if WBC \>20×109/L

Study Details

This study aims to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine and CAG as induction regimen in Patients with Refreactory/Relapse Acute Myeloid Leukemia.

Key Dates

Start date
Feb 1, 2023
Status verified
Feb 2023
Primary completion
Feb 1, 2024
Completion
Feb 1, 2026

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: VACAG（Venetoclax Combined with Azacitidine and CAG）regimen
    Participants will receive induction as azacitidine on days 1-7, venetoclax aily on days 1-28, cytarabine q12h on days 1-7, aclacinomycin on days 1,3,5,7, and granulocyte colony-stimulating factor on days 0-8. Participants will receive second induction if not reach complete remission.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: up to 2 cycles from the start of VACAG regimen (each cycle is 28 days) ]

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