Intensive Therapy Combined With Venetoclax for Adult Acute Myeloid Leukemia

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT05356169
Phase
PHASE2/PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

Study Details

300 patients will be randomly distributed into the control group (n=150) and the experimental group(n=150). Patients will receive two cycles of induction chemotherapy. The control group receives standard 3+7 induction regimen containing cytarabine (100mg/m2 d1-7) and daunorubicin (60mg/m2 d1-3). The experimental group receives venetoclax combined with intensive chemotherapy (3+7 induction regimen same as the control group). For each group, patients who fail to achieve CR/CRi after two courses of induction therapy may receive alternative therapy decided by their physicians. After CR/CRi achieved, subjects proceed allo-transplantation or consolidation therapy according to their ELN risks: subjects in favorable risk group should continue with chemotherapy; subjects in poor risk group should go through transplantation; for subjects in intermediate risk group, those with suitable donors can receive transplantation while others can continue with consolidation therapy. Subjects receive 3 courses of intermediate-dose cytarabine (1.5g/m2 q12h d1, 3, 5) for age\>55 years or high dose cytarabine (3g/m2 q12h d1, 3, 5) for age≤ 55 years as consolidation therapy with venetoclax in experimental group and without venetoclax in control group. After consolidation, patients will be observed.

Key Dates

Start date
May 19, 2022
Status verified
Feb 2025
Primary completion
May 15, 2026
Completion
Oct 15, 2027

Study Design

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

Arms

  • Experimental: Venetoclax combined with intensive chemotherapy
    The experimental group receives two cycles of inducation chemotherapy consisting of venetoclax combined with standard DA 3+7 regimen. After CR/CRi achieved, subjects proceed allo-transplantation or consolidation therapy according to their ELN risks. The consolidation chemotherapy regimen consists of three cycles of intermediate （for age\>55 years）or high（for age≤ 55 years） dose cytarabine combined with venetoclax.
  • Active Comparator: Intensive chemotherapy only
    The control group receives two cycles of inducation chemotherapy consisting of standard DA 3+7 regimen without venetoclax. After CR/CRi achieved, subjects proceed allo-transplantation or consolidation therapy according to their ELN risks. The consolidation chemotherapy regimen consists of three cycles of intermediate （for age\>55 years）or high（for age≤ 55 years） dose cytarabine without venetoclax.

Primary Outcome Measure

Event-free survival [ Time Frame: up to 12 months ]

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