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Phase II Study of Venetoclax and Revumenib for AML with MRD

This study is testing if combining two drugs, venetoclax and revumenib, can help clear minimal or measurable residual disease (MRD) in people with acute myeloid leukemia (AML). MRD means there are still a small number of leukemia cells left after treatment. This study is for people aged 12 and older who have specific genetic changes in their AML (NPM1mt, KMT2Ar, or NUP98r). The main goal is to see how safe the combination of venetoclax and revumenib is and what side effects it might cause. Researchers also want to see if this combination can get rid of MRD and improve how long people live without their leukemia coming back.

Study design
This is a multi-site study planning to enroll 8 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and adverse events will be measured through study completion, which is an average of 1 year.

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

NCT06284486

A Multi-Site Break Through Cancer Trial: Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of Venetoclax and Revumenib

Recruiting
PHASE1Ages 12+InterventionalTreatment
M.D. Anderson Cancer Center
~8 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:VenetoclaxRevumenib

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs)
Measured over Through study completion; an average of 1 year.

Conditions

Acute Myeloid Leukemia

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Where it's being run

4 sites across 4 states
Maryland1
Massachusetts1
New York1
Texas1

Study leadership

  • Ghayas Issa, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Ghayas Issa, MD
[email protected]
(713) 745-6798
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Known history of NPM1mt, or KMT2Ar, or NUP98r AML.
Bone marrow assessment showing no leukemia by morphology (blasts \<5%) in first remission following high intensity chemotherapy or at least 2 cycles of low intensity therapy (e.g. hypomethylating agent or low-dose cytarabine-based), or in second remission following any therapy, with MRD ≥ 0.1% identified by multiparameter flow cytometry using central lab testing.
No clinically active extramedullary disease. 4. Baseline ejection fraction must be \> 40%. 5. Adequate hepatic function (direct bilirubin \< 1.5x upper limit of normal (ULN) unless increase is due leukemic involvement, and AST and/or ALT \< 3x ULN unless considered due to leukemic involvement, in which case direct bilirubin or AST and/or ALT \< 5x ULN will be considered eligible). 6. Adequate renal function with an estimated glomerular filtration rate ≥ 60 mL/min based on local institutional practice for age-appropriate determination. 7. Able to swallow pills. 8. Participants or parent/guardian is willing and able to provide informed consent. Interval from prior treatment to time of initiation will be at least 14 days for cytotoxic or non-cytotoxic (immunotherapy agent(s), or an interval of 5 half-lives of the prior therapy, whichever is shorter. Concurrent therapy for central nervous system (CNS) prophylaxis or continuation of therapy for controlled CNS disease is permitted. 9. Women of childbearing potential must agree to adequate methods of contraception during the study and at least 3 months after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study and at least 3 months after the last treatment.

What this trial measures

  • Safety and adverse events (AEs)Through study completion; an average of 1 year.

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0