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Discontinuing AML Treatment with Azacitidine/Decitabine and Venetoclax

This study is for adults with Acute Myeloid Leukemia (AML) that is currently well-controlled with standard treatments like azacitidine or decitabine, combined with venetoclax. The main goal is to see if you can safely stop these medications after at least one year of treatment without your AML returning. Researchers will measure how many people achieve a complete response (CR) or complete response with incomplete blood count recovery (CRi) up to 18 months. To join, you must be 18 or older, have AML (non-M3 type), and be currently on these frontline therapies with a good response. The study plans to enroll 37 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment plan. It aims to enroll 37 adults.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will follow participants for up to 18 months to see if their AML remains in remission.

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

NCT06511882

Discontinuation of Hypomethylating Agent and Venetoclax in Patients With AML MRD

Recruiting
PHASE2Ages 18+InterventionalTreatment
H. Lee Moffitt Cancer Center and Research Institute
~37 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:AzacitidineDecitabineVenetoclax

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rates of Complete Response (CR)/Complete Response with incomplete hematologic recovery (CRi)
Measured over Up to 18 Months

Conditions

Acute Myeloid Leukemia

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Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Onyee Chan, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

Gina Bellenger
[email protected]
813-745-6138
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adults 18 years of age or older at the time of obtaining informed consent.
Diagnosed with Acute Myeloid Leukemia (AML) (non-M3) as defined by 2016 World Health Organization (WHO)
Eastern Cooperative Group (ECOG) performance status score ≤ 2
Currently on frontline therapy with HMA (azacitidine or decitabine)/VEN and achieved Complete Remission (CR)/Complete Remission with incomplete marrow recovery (CRi) with MRD negativity defined as \< 0.1% by Multiparameter Flow Cytometry (MFC)
Within 12 months of starting HMA (azacitidine or decitabine)/VEN
Ineligible for or declined allogeneic hematopoietic cell transplantation (HCT)
Ability to understand and the willingness to sign a written informed consent document
Must agree to adhere to the study visit schedule and other protocol requirements
Patients must be able to provide adequate Bone Marrow (BM) aspirate and biopsy specimens for histopathological and Measurable Residual Disease analysis during the screening procedure

Exclusion

Use of cytotoxic chemotherapeutic agents, or experimental agents (agents that are not commercially available) for the treatment of AML within 28 days, or 5 half-lives, at the start of the study. Only patients who are receiving frontline HMA (azacitidine or decitabine)/VEN are potentially eligible, but if they had received a course of hydroxyurea prior to achieving CR/CRi, this is allowed.
Any serious medical condition or uncontrolled current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or will place the subject at unacceptable risk if he/she participates in the study. Controlled infections or other medical conditions on long-term therapy is allowed.
Patients who harbored TP53 mutation at diagnosis
AML with extramedullary involvement including central nervous system (CNS) involvement, myeloid sarcoma, and leukemia cutis requiring directed therapy at the time of enrollment.
Patient is pregnant.

What this trial measures

  • Rates of Complete Response (CR)/Complete Response with incomplete hematologic recovery (CRi)Up to 18 Months

    Rates of CR/CRi at 18 months from the time of initial CR/CRi in patients who discontinue frontline HMA (azacitidine or decitabine)/VEN (venetoclax) after achieving Measurable Residual Disease (MRD) negativity by MFC within 12 months of starting therapy. The Null hypothesis (p0) will be tested against the alternative hypothesis (p1). Null hypothesis: p0 ≤ 50% will remain in CR/CRi at 18 months from the time of initial CR/CRi Alternative hypothesis: p1 ≥ 70% will remain in CR/CRi at 18 months from the time of initial CR/CRi