Shortened Venetoclax Duration Based on Day 14 BM Blasts Versus Standard Therapy in Elderly or Frail Patients With AML Patients Treated With Azacitidine Plus Venetoclax

Sponsor
Peking University People's Hospital
Study ID
NCT07407660
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Tablet
  • Azacitidine (AZA) — DRUG
    Solution for subcutaneous

Study Details

This study aims to compare the efficacy and safety of a shortened treatment course based on the bone marrow blast count on Day 14 versus standard treatment in patients with acute myeloid leukemia treated with venetoclax plus azacitidine.

Key Dates

Start date
Feb 1, 2026
Status verified
Feb 2026
Primary completion
Feb 1, 2028
Completion
Feb 1, 2030

Study Design

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

Arms

  • Experimental: Optimized treatment
    Bone marrow aspiration is perfomed on day 14 of the first induction cycle. If the bone marrow blast count is \<5%, the duration of venetoclax will be shortened to 14 days; otherwise, the 28-day course will be completed. In the second cycle, patients who fail to achieve CR/CRi and those who achieve CR will receive a 28-day course of venetoclax plus azacitidine; for patients who achieve CRi, a 21-day course of venetoclax plus azacitidine will be administered within 14 days following the first cycle. Treatment for subsequent cycles will be determined according to the investigators' local clinical practice, including but not limited to continued venetoclax-azacitidine therapy, switching to intensive chemotherapy, or allogeneic hematopoietic stem cell transplantation.
  • Active Comparator: Standard treatment
    No bone marrow assessment was performed on day 14 of the first induction cycle. All the patients receive the 28-day course of venetoclax plus azacitidine for the first cycle. In the second cycle, patients who fail to achieve CR/CRi and those who achieve CR will receive a 28-day course of venetoclax plus azacitidine; for patients who achieve CRi, a 21-day course of venetoclax plus azacitidine will be administered within 14 days following the first cycle. Treatment for subsequent cycles will be determined according to the investigators' local clinical practice, including but not limited to continued venetoclax-azacitidine therapy, switching to intensive chemotherapy, or allogeneic hematopoietic stem cell transplantation.

Primary Outcome Measure

Achievement of CR/CRi within 2 treatment cycles [ Time Frame: At the end of Cycle 1 and Cycle 2 (each cycle is 28 days). If CRi, repeat 2 weeks later. ]

Central Contacts

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