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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06903702
Phase
PHASE2
Status
Recruiting
Apply to this trial

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

Start date
Jun 4, 2025
Status verified
Aug 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
100 participants (estimated)
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 ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Roni Tamari, MD
[email protected]
Memorial Sloan Kettering Monmouth (Consent and Follow-up)MiddletownNew Jersey07748
Roni Tamari, MD
[email protected]
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Roni Tamari, MD
[email protected]
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Roni Tamari, MD
[email protected]
Memorial Sloan Kettering Cancer Center - Suffolk (Limited Protocol Activities)CommackNew York11725
Roni Tamari, MD
[email protected]
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Roni Tamari, MD
[email protected]
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Roni Tamari, MD
[email protected]

Find similar trials in Basking Ridge, NJ

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Consent and Follow-up)· Middletown, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Cancer Center - Suffolk (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NY

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