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

NCT07605949 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: LCCC2508
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

This study is testing a new treatment combination called RAVEN, which includes revumenib, azacitidine, and venetoclax, in patients who are newly diagnosed with a specific type of acute myeloid leukemia (AML) called KMT2A- translocated AML. People with this type of AML often have poor outcomes, so new treatments are needed that may work better and cause fewer side effects. The study has two parts:

1. 1.Induction Phase: Patients will receive treatment for up to 3 cycles. Each cycle lasts 28 days. The goal is to help the leukemia go into remission.
2. 2.Continuation Phase: After remission and blood count recovery, patients will continue treatment until the leukemia returns, side effects become too severe, the patient receives a stem cell transplant, or another reason to stop treatment occurs.

Conditions

Leukemia Acute Myeloid

Keywords

revumenib; azacitidine; venetoclax; allogeneic stem cell transplant

Outcome Measures

Primary Outcomes (1)

• Complete remission rate

  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)

  Up to 3 months

Secondary Outcomes (7)

• Composite Complete remission

  Up to 3 months

• Duration of complete remission (DOCR)

  Up to 2 years

• Event-free survival

  Up to 2 years

• The number of treatment-emergent adverse events

  Up to 2 years

• Relapse-free survival

  Up to 2 years

Study Arms (1)

KMT2A-translocated (KMT2Ar) acute myeloid leukemia (AML)

EXPERIMENTAL

Patients with KMT2A-translocated (KMT2Ar) acute myeloid leukemia (AML) did not receive a treatment.

Drug: Azacitidine; Drug: Venetoclax; Drug: Revumenib

Interventions

Azacitidine DRUG

Subcutaneous or IV over 10-40 minutes on Days 1-7 or days 1-5, 8-9, in every 28 days, for 3 cycles.

KMT2A-translocated (KMT2Ar) acute myeloid leukemia (AML)

Venetoclax DRUG

Per oral, daily in combination with posaconazole for 1- 28 days, for 3 cycles.

KMT2A-translocated (KMT2Ar) acute myeloid leukemia (AML)

Revumenib DRUG

Per oral,12 hours in combination with posaconazole for 1- 28 days , for 3 cycles.

KMT2A-translocated (KMT2Ar) acute myeloid leukemia (AML)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine; venetoclax; revumenib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Joshua Zeidner, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Higgins

CONTACT

919-984-0000; Lauren_Higgins@med.unc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study uses a structured, stepwise design. All participants begin with induction therapy. Patients who do not respond discontinue treatment, while those who achieve remission proceed to the continuation phase. During continuation therapy, patients may either remain on treatment until relapse/progression or proceed to allogeneic stem cell transplant.

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 26, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

US (1)