Study on Revumenib with Azacitidine and Venetoclax for Patients with Specific Genetic Mutations in AML

Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland

Sponsor score: 0

ClinicalTrials ID:NCT06652438

This clinical trial is exploring whether adding the drug Revumenib to the standard treatment of azacitidine and venetoclax can improve outcomes for patients with acute myeloid leukemia (AML) who have specific genetic mutations and cannot undergo intensive chemotherapy.

Patient Parameters

Parameter	Options

Program Overview

This study is focused on patients with newly diagnosed acute myeloid leukemia (AML) who have specific genetic mutations (NPM1 or KMT2A) and are not eligible for intensive chemotherapy. The standard treatment for these patients includes azacitidine and venetoclax, which has shown progress but is not a cure. Revumenib is a drug that targets a molecule called menin, which is important for the growth of certain leukemia cells. By blocking menin, Revumenib may help prevent the production of these leukemia cells. The study aims to see if adding Revumenib to the standard treatment can improve patient outcomes. Participants will be randomly assigned to receive either the combination with Revumenib or a placebo, and their progress will be monitored over time.

Eligibility Criteria

Inclusion Criteria

Have newly diagnosed AML with specific genetic mutations (NPM1 or KMT2A) confirmed by a central lab.
Be 18 years or older, with no upper age limit.
Not eligible for intensive chemotherapy due to age (75 or older) or certain health conditions (e.g., heart issues, lung function, kidney function, liver function).
Have a life expectancy of at least 12 weeks.
Have a white blood cell count below a certain level, which can be managed with medication before joining the study.
Have adequate kidney and liver function based on specific blood tests.
Women must not be pregnant or breastfeeding and must agree to use effective birth control during the study and for 6 months after.
Men must agree to use condoms during sexual activity and not father a child during the study and for 6 months after.
Be able to understand and sign an informed consent form.

Exclusion Criteria

Have received previous treatment for AML, except for certain medications to control white blood cell counts.
Have a different type of leukemia or certain genetic conditions.
Have significant heart disease or recent stroke.
Have active infections that are not controlled.
Have other active cancers, unless they are considered low risk.
Have received a live vaccine recently.
Have severe mental health conditions that affect the ability to consent.
Have allergies to the study drugs.
Weigh less than 40 kg.
Be participating in other clinical trials with similar treatments.
Be taking certain medications that interfere with the study drugs.
Be pregnant or planning to become pregnant during the study.

Locations

FACILITY	ZIP	CITY	STATE
US-Los Angeles CA-UCLA	90095	Los Angeles	California
US-San Francisco CA-UCSF	94143	San Francisco	California
US-Jacksonville FL-MAYOFL	32224	Jacksonville	Florida
US-Atlanta GA-EMORY	30322	Atlanta	Georgia
US-Kansas City KS-KUMC	66205	Fairway	Kansas
US-Baltimore MD-UMGCCC	21201	Baltimore	Maryland
US-Rochester MN-MAYOMN	55905	Rochester	Minnesota
US-New York-MSKCC	10065	New York	New York
US-Chapel Hill-UNCNORTHCAROLINA	27514	Chapel Hill	North Carolina
US-Cincinnati OH-CINCY	45219	Cincinnati	Ohio

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