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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
88
Subcutaneous or IV over 10-40 minutes on Days 1-7 or days 1-5, 8-9, in every 28 days, for 3 cycles.
Per oral, daily in combination with posaconazole for 1- 28 days, for 3 cycles.
Per oral,12 hours in combination with posaconazole for 1- 28 days , for 3 cycles.
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
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)
Time frame: Up to 3 months
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.
Time frame: Up to 3 months
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)
Time frame: Up to 2 years
Event-free survival
Event-free survival will be determined as time until treatment failure (lack of CRc), relapse or death.
Time frame: Up to 2 years
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.
Time frame: Up to 2 years
Relapse-free survival
Relapse-free survival will be determined as time to relapse or death after achieving CR.
Time frame: Up to 2 years
Overall survival
Overall survival will be determined as time until date of death from any cause.
Time frame: Up to 2 years
MRD-Negative (MRD<0.02%) complete remission
MRD-Negative (MRD\<0.02%) complete remission rate will be assessed from bone marrow samples using Hematologics Flow MRD assay after 2 cycles of RAVEN treatment
Time frame: Up to 3 months
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