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Discontinuation of Hypomethylating Agent and Venetoclax in Patients With AML MRD | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Discontinuation of Hypomethylating Agent and Venetoclax in Patients With AML MRD

Discontinuation of Hypomethylating Agent and Venetoclax in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Who Have Achieved Negative Measurable Residual Disease (MRD)

NCT06511882•H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

Summary

The purpose of this research study is to see if people whose Acute myeloid leukemia (AML) is being successfully treated with azacitidine or decitabine in combination with venetoclax can discontinue this chemotherapy for some period of time after a year of treatment without increasing the likelihood that their AML will return.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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.

Locations (1)

Moffitt Cancer Center

Tampa, Florida, United States

Key Dates

Start Date

November 7, 2024

Primary Completion Date

October 1, 2027

Completion Date

August 1, 2028

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Acute Myeloid Leukemia

Interventions

Azacitidine

DRUG

Decitabine

DRUG

Venetoclax

DRUG

Contacts

Gina Bellenger

CONTACT

813-745-6138 Gina.Bellenger@moffitt.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Discontinuation of Hypomethylating Agent and Venetoclax in Patients With AML MRD

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

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