VA vs DA for Newly Diagnosed Hig-risk AML

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT05939180
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax Oral Tablet — DRUG
    VA regimen: azacytidine, 75mg/m2, subcutaneously, on days 1-7; venetoclax, orally, once a day, 100mg, d1; 200mg, d2; 400mg, days 3-28.
  • Daunorubicin — DRUG
    DA regimen: daunorubicin (60mg/m2) on days 1-3, intraveneously injection, and cytarabine (100mg/m2) on days 1-7, intraveneously injection, for 1 cycle.

Study Details

This is an open-label, multicenter, phase 2b, randomized study aiming to compare the efficacy and safety of venetoclax plus azacytidine Versus daunorubicin plus cytarabine (conventional 7+3 regimen) in adult acute myeloid leukemia (AML) patients with adverse risk featuress. Participants will be 1:1 randomly assigned to the VA and DA groups. Once remission was achieved, consolidated chemotherapy will be performed and allogeneic hematopoietic stem cell transplantation is strongly recommended. After completion of the study intervention, participants will be followed-up every 1 to 2 months for up to 2 years.

Key Dates

Start date
Apr 1, 2024
Status verified
Jun 2023
Primary completion
Oct 1, 2025
Completion
Oct 1, 2027

Study Design

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

Arms

  • Experimental: VA regimen
    VA regimen: azacytidine and venetoclax
  • Active Comparator: DA regimen
    DA regimen: daunorubicin and cytarabine

Primary Outcome Measure

Composite complete remission (CRc) after one course of induction therapy [ Time Frame: From randomization to the end of the first course of induction therapy (within 28 days) ]

Central Contacts

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