Venetoclax + Decitabine vs. "7+3" Induction Chemotherapy in Young AML

Sponsor
Chen Suning
Study ID
NCT05177731
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • AML, Adult
  • Chemotherapy Effect

Eligibility Criteria

Sex
ALL
Age
18 Years - 59 Years
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Orally by mouth
  • Decitabine for Injection — DRUG
    Intravenous infusion
  • Cytarabine — DRUG
    Intravenous infusion
  • Idarubicin — DRUG
    Intravenous infusion
  • Gilteritinib — DRUG
    Orally by mouth

Study Details

This research is being done to assess the therapeutic efficacy and safety of a promising (venetoclax and decitabine) versus conventional "7+3"chemotherapy in induction young patients with acute myeloid leukemia. This study involves the following: Venetoclax and decitabine (investigational combination) Cytarabine and idarubicin (per standard of care)

Key Dates

Start date
Mar 1, 2022
Status verified
Oct 2024
Primary completion
Feb 28, 2024
Completion
Dec 31, 2024

Study Design

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

Arms

  • Experimental: Investigational ( venetoclax, decitabine)
    Randomized participants will receive induction as decitabine on days 1-5 and venetoclax daily on days 1-28. Second Induction (if not reach complete remission, but the percentage of blaste cells in bone marrow decreased by more than 50%):Re-induction with pre-induction therapy. Consolidation: If patients with favorable risk and MRD (Minimal Residual Disease) negative or refuse to allo-HSCT (Hematopoietic stem-cell transplantation), intermediate-dose (2g/m2 q12h days 1-3) for 4 cycles. If patients with intermediate or poor risk or favorable risk but MRD positive, intermediate-dose cytarabine for 1-2 cycles and follow up with allo-HSCT. For patients with FLT3 mutation, gilteritinib can be combined with the follow-up treatment after the end of initial induction.
  • Experimental: Standard of Care (Conventional Induction "7+3")
    Randomized participants will receive cytarabine and idarubicin per standard of care as follows: Induction: cytarabine on days 1-7 and idarubicin (12mg/m2) on days 1-3 . Second Induction (if not reach complete remission, but the percentage of blaste cells in bone marrow decreased by more than 50%): Re-induction with pre-induction therapy. Consolidation: If patients with favorable risk and MRD negative or refuse to allo-HSCT, intermediate-dose cytarabine (2g/m2 q12h days 1-3) for 4 cycles. If patients with intermediate or poor risk or favorable risk but MRD positive, intermediate-dose cytarabine for 1-2 cycles and follow up with allo-HSCT. For patients with FLT3 mutation, gilteritinib can be combined with the follow-up treatment after the end of initial induction.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: From randomization to 2 cycles of induction before consolidation therapy（100 days） ]

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