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.
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
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).
Single group
Azacitidine
DrugSubcutaneous or IV over 10-40 minutes on Days 1-7 or days 1-5, 8-9, in every 28 days, for 3 cycles.
Venetoclax
DrugPer oral, daily in combination with posaconazole for 1- 28 days, for 3 cycles.
Revumenib
DrugPer oral,12 hours in combination with posaconazole for 1- 28 days , for 3 cycles.
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)
Composite Complete remission
Composite Complete remission (CCr) rate defined as complete remission (CR) + complete remission with incomplete recovery (CRi) + complete remission with partial hematologic recovery (CCr)= CR + CRi + CRh. CR: 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) CRi = All CR criteria except for residual neutropenia \<1.0 × 109/L (1,000/μL) or thrombocytopenia \< 100× 109/L (100 000/μL CRh: ANC ≥ 0.5 × 109/L (500/μL) and platelet count ≥50 × 109/L (50 000/μL), otherwise all other CR criteria met.
Duration of complete remission (DOCR)
Duration of complete remission (DOCR) will be defined as the time from the first complete remission to hematological relapse or death from any cause. CR: 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)
Event-free survival
Event-free survival will be determined as time until treatment failure (lack of CRc), relapse or death.
The number of treatment-emergent adverse events
The number of treatment-emergent special interest (AESIs) and serious adverse events (SAEs), and clinically significant test results will be submitted.
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This trial is not recruiting at the moment. You can still explore other options:
