Revumenib with azacitidine and venetoclax for newly diagnosed KMT2A-rearranged acute myeloid leukemia
Tests revumenib, azacitidine and venetoclax in adults newly diagnosed with KMT2A-rearranged AML.
Plain-language title generated from the registry record
Registry title: Revumenib, Azacitidine, and VENetoclax in Newly Diagnosed KMT2A-Rearranged AML
Key facts
- Where
- Chapel Hill, United StatesSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07605949, who can take part
Where in United States
- Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel HillChapel Hill, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- UNC Lineberger Comprehensive Cancer Center
- Trial code
- NCT07605949
- Record updated
- 5 November 2026
- Original description
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.Read full original descriptionShow less
Revumenib, Azacitidine, and VENetoclax in Newly Diagnosed KMT2A-Rearranged AML
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. 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. 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.
Patients who receive an allogeneic stem cell transplant (stem cells from a donor) may also join a separate part of the study to test revumenib as maintenance treatment after transplant.
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).