Revumenib, Azacitidine, and VENetoclax in Newly Diagnosed KMT2A-Rearranged AML
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Azacitidine, Venetoclax, Revumenib.
- Who it may be relevant to
- Registry conditions: Leukemia Acute Myeloid. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Azacitidine
Subcutaneous or IV over 10-40 minutes on Days 1-7 or days 1-5, 8-9, in every 28 days, for 3 cycles. - Drug Venetoclax
Per oral, daily in combination with posaconazole for 1- 28 days, for 3 cycles. - Drug Revumenib
Per oral,12 hours in combination with posaconazole for 1- 28 days , for 3 cycles.
Primary outcome measures
- Complete remission rate [Time frame: Up to 3 months]
Secondary outcome measures (7)
- Composite Complete remission [Time frame: Up to 3 months]
- Duration of complete remission (DOCR) [Time frame: Up to 2 years]
- Event-free survival [Time frame: Up to 2 years]
- The number of treatment-emergent adverse events [Time frame: Up to 2 years]
- Relapse-free survival [Time frame: Up to 2 years]
- Overall survival [Time frame: Up to 2 years]
- MRD-Negative (MRD<0.02%) complete remission [Time frame: Up to 3 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill — Chapel Hill
Identifiers
NCT: NCT07605949 · LCCC2508