Phase II Study on Dual Inhibition of BCL2 and Menin in AML Using Venetoclax and Revumenib

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT06284486

Provider View

This clinical trial is exploring whether a combination of two drugs, venetoclax and revumenib, can help control acute myeloid leukemia (AML) in patients who still have minimal residual disease (MRD) after initial treatment.

Patient Parameters

Program Overview

The study aims to find out if the combination of venetoclax and revumenib can effectively reduce minimal residual disease (MRD) in patients with acute myeloid leukemia (AML). The trial will also assess the safety and best dosage of these drugs when used together. Researchers will look at how long patients live without the disease coming back, how long they stay free of events related to the disease, and how long the response to treatment lasts. Additionally, the study will explore how well the drugs work in children and examine specific markers that might predict how well the treatment works or if there is resistance.

Description

This study is divided into two phases. In Phase I, the focus is on determining the safety and appropriate dosage of the drug combination for patients with AML who have minimal residual disease (MRD). In Phase II, the effectiveness of the drug combination in clearing MRD will be evaluated.

Secondary goals include assessing overall survival, relapse-free survival, event-free survival, and the duration of response to the treatment. The study will also explore the relationship between MRD negativity and clinical outcomes, such as survival and relapse risk. Researchers will evaluate the consistency of standard and new MRD tests and investigate the safety and activity of the drug combination in children.

Eligibility Criteria

Inclusion Criteria

  • Must be 12 years or older and weigh at least 45 kg.
  • Have a performance status score of 2 or less, indicating good overall health.
  • Have a specific type of AML with certain genetic markers and minimal residual disease (MRD) after initial treatment.
  • No active leukemia outside the bone marrow.
  • Heart function must be above 40%.
  • Have adequate liver and kidney function based on specific blood tests.
  • Must be able to swallow pills.
  • Must agree to provide informed consent and follow study requirements.
  • Women of childbearing potential must use effective contraception during the study and for 3 months after. Men must also agree to use contraception during the study and for 3 months after.

Exclusion Criteria

  • Have previously been treated with a menin inhibitor.
  • Are expected to benefit from standard therapy or proceed with stem cell transplantation soon.
  • Have uncontrolled medical conditions or psychiatric illness that could increase risk.
  • Cannot use other cancer treatments during the study, except for specific exceptions like certain chemotherapy for CNS leukemia or steroids for differentiation syndrome.
  • Have severe gastrointestinal or metabolic conditions affecting drug absorption.
  • Have another active cancer being treated.
  • Have active hepatitis B, hepatitis C, or HIV infection.
  • Are pregnant or breastfeeding.
  • Have an active uncontrolled infection.
  • Have had serious heart or brain conditions in the past 6 months.
  • Have a prolonged QT interval on an ECG.
  • Have any condition that might interfere with the study or is not in the patient's best interest.
  • Have active CNS leukemia.
  • Are on immunosuppressive therapy post-transplant at screening.
  • Have active or severe graft-versus-host disease (GVHD).

Locations

FACILITYZIPCITYSTATE
MD Anderson Cancer Center77030HoustonTexas

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