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Study of Azacitidine and Venetoclax vs. Stem Cell Transplant for AML in Older Adults

This study is for people aged 65 and older with acute myeloid leukemia (AML). Researchers want to compare two ways to prevent AML from coming back (relapsing): either an allogeneic hematopoietic stem cell transplant (HSCT), which replaces unhealthy blood-forming cells with healthy ones, or maintenance therapy using two drugs, azacitidine and venetoclax. You would have already received azacitidine and venetoclax for your AML diagnosis to be eligible. The main goal is to see which treatment leads to a longer time without relapse after one year. About 100 people are planned to join this study, but its current recruitment status is unclear.

Study design
This interventional study plans to enroll 100 participants aged 65 and older. It compares two treatments for acute myeloid leukemia: azacitidine and venetoclax, or an allogeneic hematopoietic stem cell transplant.
What's involved
You would receive azacitidine daily for 7 days per cycle, and venetoclax orally daily for 28 days. If assigned to the transplant group, you would undergo the HSCT procedure after conditioning treatment.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures relapse-free survival at 1 year, suggesting follow-up for at least this duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06903702

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

Withdrawn
PHASE2Ages 65+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Azacitidine (AZA)VenetoclaxAllogeneic hematopoietic stem cell transplantation

At a glance

Recruiting sites

Site status isn't published for this study.

What they're measuring
1-year Relapse free survival (RFS)
Measured over 1 year

Conditions

Acute Myeloid Leukemia

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Acute Myeloid Leukemia

Study leadership

  • Roni Tamari, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adult patients ≥65 years of age at the time of signing the informed consent form.
Confirmed diagnosis of acute myeloid leukemia according to the ELN 2017 criteria
Treatment with azacitidine and venetoclax for the diagnosis of AML
Patients with adequate organ function to be considered as candidates for allo-HCT:
Cardiac: asymptomatic or if symptomatic, then LVEF at rest must be \>40% and must improve with exercise.
Renal: CrCl ≥50 ml/min (measured or calculated/estimated).
Pulmonary: asymptomatic or if symptomatic, DLCO \> 50% of predicted (corrected for hemoglobin)
Hepatic: \< 5x ULN liver function tests and \< 2x ULN total serum bilirubin, unless there is congenital benign hyperbilirubinemia.
KPS of ≥ 70
Patients with suitable donor for allo-HCT
Patients must achieve a morphologic remission \<5% blast with MRD negative status by flow cytometry (defined as one or less residual leukemic blasts per 1000 leukocytes (or 10\^3)) meeting one of the below:
Complete remission (CR) defined as: \<5% blasts with ANC\> 1000 AND Plt \>100K
CRh defined as \<5% blasts with ANC \> 500 AND Plt \>50K
CRi defined as \<5% blasts with ANC\< 1000 OR Plt \< 100K
Subject is willing and able to adhere to the study visit schedule and other protocol requirements.

Exclusion

Patients who are not considered to be transplant eligible (either due to lack of suitable donor or due to comorbidities/performance status). The reason the patient is not considered transplant eligible will be documented in the eCRF.
History of prior allo-HCT
Patients who underwent prior leukemia directed treatment (other than aza/ven)
Patients with CNS involvement at any time point prior to enrollment.
Patients with previous exposure to venetoclax or an HMA for the treatment of a myeloid malignancy
Patients who are planned for treatment other than AZA/VEN
Patients who are planned for treatment with HMA/VEN with another agent (e.g. a "triplet")
Presence of any other condition that may increase the risk associated with study participation, and in the opinion of the investigator, would make the patient inappropriate for entry into the study.

What this trial measures

  • 1-year Relapse free survival (RFS)1 year

    Relapse free survival (RFS)- will be defined with patients being alive and without any evidence of disease. i.e. no morphologic relapse and no emergence of minimal residual disease. In the event of emergence of MRD without a morphologic relapse, this will be defined as relapse only if documented on 2 separate time points. For patients alive and in remission at the data cut-off, RFS will be censored at the last assessment date.