A Study of Azacitidine and Venetoclax Versus a Stem Cell Transplant in People 65 Years and Older With Acute Myeloid Leukemia

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06903702
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Azacitidine (AZA) — DRUG
    given daily for 7 days starting on Day 1 of each Cycle
  • Venetoclax — DRUG
    orally daily for 28 days
  • Allogeneic hematopoietic stem cell transplantation — PROCEDURE
    After the conditioning treatment, the HSCT procedure is part of standard care on Day 0.

Study Details

The researchers are doing this study to find out if an allogeneic hematopoietic stem cell transplant (HSCT) or maintenance therapy with azacitidine and venetoclax is more effective at keeping AML from coming back (relapsing).

Key Dates

First listed
Apr 1, 2025
Start date
Aug 4, 2026
Status verified
Aug 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

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

Arms

  • Experimental: maintenance arm Azacitidine and Venetoclax (AZA/VEN)
    Patients randomized to the maintenance arm (AZA/VEN) will be treated with azacitidine given daily for 7 days starting on Day 1 of each Cycle (7 consecutive days or a total of 7 days with a 2 day break due to weekends or holidays is permissible). Venetoclax will be taken orally daily for 28 days. A cycle will be considered 28 days.
  • Experimental: Allogeneic hematopoietic stem cell transplantation (Allo-HCT arm)
    Patients who are randomized to the transplant arm will start the conditioning regimen no later than 6 weeks (day 42) after C2D1 of AZA/VEN.

Primary Outcome Measure

1-year Relapse free survival (RFS) [ Time Frame: 1 year ]

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