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RAVEN Treatment for KMT2A-Rearranged AML

This study is testing a new treatment combination called RAVEN for people newly diagnosed with a specific type of acute myeloid leukemia (AML) called KMT2A-rearranged AML. This type of AML often has poor outcomes, so researchers are looking for better treatments. The RAVEN combination includes revumenib, azacitidine, and venetoclax. The main goal is to see how many patients achieve complete remission (when signs of cancer disappear) within three months. You may be able to join if you are between 18 and 65 years old and have this specific type of AML. The study is currently recruiting 88 participants.

Study design
This study is testing a new treatment combination in 88 participants. It is an interventional study, meaning participants will receive the study treatments.
What's involved
Participants will receive treatment for up to three 28-day cycles in the induction phase. If the leukemia goes into remission, treatment may continue in a continuation phase.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, complete remission rate, is measured up to 3 months.

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

NCT07605949

Revumenib, Azacitidine, and VENetoclax in Newly Diagnosed KMT2A-Rearranged AML

Not Yet Recruiting
PHASE2Ages 18–65InterventionalTreatment
UNC Lineberger Comprehensive Cancer Center
~88 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:AzacitidineVenetoclaxRevumenib

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete remission rate
Measured over Up to 3 months

Conditions

Leukemia Acute Myeloid

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Acute Myeloid LeukemiaKMT2A Gene

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Joshua Zeidner, MD · PRINCIPAL_INVESTIGATOR · UNC Lineberger Comprehensive Cancer Center

Who to contact

Lauren Higgins
[email protected]
919-984-0000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
Age 18-65 years at the time of consent.
Untreated AML based on 2022 WHO or ICC criteria with KMT2A translocation by local standard diagnostic testing by cytogenetics/karyotype or FISH

Exclusion

Isolated myeloid sarcoma (patients must have blood or marrow involvement with AML to enter study)
Active central nervous system (CNS) involvement by AML. Of note, patients are eligible if CNS leukemia is in remission at the time of study entry.
Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).

What this trial measures

  • Complete remission rateUp to 3 months

    Complete remission (CR) rate will be determined as defined in the protocol Response Criteria. Bone marrow blasts \< 5%; absence of circulating blasts; absence of extramedullary disease; ANC \> 1.0 × 109/L (1,000/μL); platelet count ≥ 100 × 109/L (100 000/μL)