Recruiting
Phase 2

Hypomethylating Agent with Venetoclax

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT06511882

Conditions

Acute Myeloid Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Azacitidine

Decitabine

Venetoclax

Study Details

Brief 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.

Conditions

Acute Myeloid Leukemia

Study ID

NCT06511882

Start date

Nov 7, 2024

Status verified date

Feb, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

37 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Consolidation and Discontinuation

Consolidation: Patient will receive HMA (azacitidine or decitabine)/VEN (venetoclax) as part of standard of care treatment.

At the conclusion of consolidation, if the results of the bone marrow biopsy are a negative Measurable Residual Disease (MRD), patient will continue to Discontinuation.

Discontinuation:

Monthly clinic visits with laboratory assessment and bone marrow biopsies (BMBs) with MRD testing every 3 months to closely monitor disease status. At any point of the study if molecular relapse (including MRD emergence), or morphologic relapse, therapy will be reinitiated.

If only molecular relapse, HMA (azacitidine or decitabine)/VEN (venetoclax) will be reinitiated with the same monitoring schedule as before.

If morphologic relapse, HMA (azacitidine or decitabine)/VEN (venetoclax) will be reinitiated for 2 cycles.

If no response (NR), patient will be taken off Study.

Interventions

Azacitidine

Standard of Care Intravenous (IV) infusion

Decitabine

Standard of Care Intravenous (IV) infusion

Venetoclax

Standard of Care PO (By Mouth)

Primary outcome measure

  • Rates of Complete Response (CR)/Complete Response with incomplete hematologic recovery (CRi) [ Time Frame: Up to 18 Months ]

Central Contacts and Locations

Central contacts

Gina Bellenger

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

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Gina Bellenger

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

Principal Investigator:

Onyee Chan, MD

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • AML

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2026-02-27.