Actively Recruiting
Discontinuation of Hypomethylating Agent and Venetoclax in Patients With AML MRD
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-02-27
37
Participants Needed
1
Research Sites
194 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Discontinuation of Hypomethylating Agent and Venetoclax in Patients With AML MRD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older at the time of informed consent
- Diagnosed with Acute Myeloid Leukemia (non-M3) per 2016 WHO criteria
- ECOG performance status score of 2 or less
- Currently on frontline therapy with azacitidine or decitabine plus venetoclax and achieved complete remission or complete remission with incomplete marrow recovery with MRD negativity (less than 0.1% by multiparameter flow cytometry)
- Within 12 months of starting azacitidine or decitabine plus venetoclax
- Ineligible for or declined allogeneic hematopoietic cell transplantation
- Able to understand and willing to sign informed consent
- Willing to follow study visit schedule and protocol requirements
- Able to provide adequate bone marrow aspirate and biopsy samples for analysis during screening
You will not qualify if you...
- Use of cytotoxic chemotherapy or experimental agents for AML within 28 days or 5 half-lives prior to study start, except hydroxyurea prior to remission
- Any serious or uncontrolled medical condition including active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social issues limiting study compliance or causing unacceptable risk
- Presence of TP53 mutation at diagnosis
- AML with extramedullary involvement requiring directed therapy at enrollment, including CNS involvement, myeloid sarcoma, or leukemia cutis
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
G
Gina Bellenger
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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