RECRUITING

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

Conditions

Acute Myeloid Leukemia Azacitidine Venetoclax Allogeneic Stem Cell Transplant

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2025-06-04

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06903702

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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.

Inclusion Criteria

Exclusion Criteria

* 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.

* 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.

Contacts and Locations

Study Contact

Roni Tamari, MD

CONTACT

646-608-3738

ABMTTrials@mskcc.org

Eytan Stein, MD

CONTACT

646-608-3749

Principal Investigator

Roni Tamari, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (Consent and Follow-up)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

United States

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

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-04

Study Completion Date2027-06

Study Record Updates

Study Start Date2025-06-04

Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

Azacitidine
Venetoclax
Allogeneic Stem Cell Transplant

Additional Relevant MeSH Terms

Acute Myeloid Leukemia