AZA + Venetoclax as Maintenance Therapy in Younger Adults With AML in First Remission

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT05404906
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Acute Myeloid Leukemia (AML) in Remission

Eligibility Criteria

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

Interventions

  • Azacitidine — DRUG
    Given SC
  • Venetoclax — DRUG
    Given PO
  • Supportive care — OTHER
    Patients will receive disease monitoring and supportive care for any complication.

Study Details

This phase III trial is conducted to evaluate if azacitidine in combination with venetoclax as maintenance therapy improves relapse-free survival (RFS) for younger adults with favorable-risk acute myeloid leukemia (AML) who remained in first complete remission (CR1) following intensive consolidation.

Key Dates

Start date
Jun 25, 2022
Status verified
Aug 2022
Primary completion
Jun 30, 2028
Completion
Jun 30, 2030

Study Design

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

Arms

  • Experimental: Treatment (azacytidine+venetoclax)
    Participants will receive azacytidine QD, on Days 1-5 and venetoclax QD, on Days 1-14 of each 28-day cycle for 8 cycles.
  • Experimental: Comparator ( best supportive care)
    Participants will receive observation and supportive care during remission.

Primary Outcome Measure

Relapse-free survival (RFS) [ Time Frame: From date of complete remission (CR) or complete remission with incomplete count recovery (CRi), to relapse or death from any cause, up to approximately 3 years ]

Central Contacts

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