RecruitingPhase 2NCT06903702

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

A Randomized, Multicenter, Phase II Study of Maintenance Azacitidine and Venetoclax Versus an Allogeneic Stem Cell Transplant in Older Patients (65 Years and Older) With Acute Myeloid Leukemia Who Achieve an MRD Negative Complete Remission After Induction With Azacitidine and Venetoclax


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

100 participants

Start Date

Jun 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment paths for older adults (65+) with acute myeloid leukemia (AML) who have responded to initial chemotherapy with azacitidine and venetoclax: continuing with more cycles of the same chemotherapy versus proceeding to a stem cell transplant (bone marrow transplant). **You may be eligible if...** - You are 65 years old or older - You have confirmed acute myeloid leukemia (AML) - You are currently being treated with azacitidine and venetoclax - Your heart, liver, and kidney function are adequate to be considered for a stem cell transplant **You may NOT be eligible if...** - Your AML has not responded to the initial chemotherapy - You have severe organ dysfunction that rules out transplant eligibility - You are not willing to be randomly assigned between treatments - You have active uncontrolled infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAzacitidine (AZA)

given daily for 7 days starting on Day 1 of each Cycle

DRUGVenetoclax

orally daily for 28 days

PROCEDUREAllogeneic hematopoietic stem cell transplantation

After the conditioning treatment, the HSCT procedure is part of standard care on Day 0.


Locations(7)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Consent and Follow-up)

Middletown, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center - Suffolk (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06903702


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