Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With
This is a research study to find out if adding a new study drug called revumenib to commonly used chemotherapy drugs is safe and if they have beneficial effects in treating patients with acute myeloid leukemia (AML) or acute leukemia of ambiguous lineage (ALAL) that did not go into remission after treatment (refractory
| Condition(s) | Refractory Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia, Acute Leukemia of Ambiguous Lineage |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This is a research study to find out if adding a new study drug called revumenib to commonly used chemotherapy drugs is safe and if they have beneficial effects in treating patients with acute myeloid leukemia (AML) or acute leukemia of ambiguous lineage (ALAL) that did not go into remission after treatment (refractory) or has come back after treatment (relapsed), and to determine the total dose of the 3-drug combination of revumenib, azacitidine and venetoclax that can be given safely in participants also taking an anti-fungal drug. Primary Objective * To determine the safety and tolerability of revumenib + azacitidine + venetoclax in pediatric patients with relapsed or refractory AML or ALAL. Secondary Objectives * Describe the rates of complete remission (CR), complete remission with in |
| Who can participate | Inclusion Criteria: Participants must have a diagnosis of AML or ALAL and meet the criteria below: * Refractory leukemia, defined as persistent leukemia after at least two courses of induction chemotherapy (one course for secondary AML), or relapsed leukemia, defined as the re-appearance of leukemia after the achievement of remission. Patients must have ≥5% blasts in the bone marrow as assessed by morphology or ≥1% blasts flow cytometry. However, if an adequate bone marrow sample cannot be obtained (e.g., in a patient with acute megakaryoblastic leukemia with marrow fibrosis), patients may be enrolled if there is unequivocal evidence of leukemia with ≥5% blasts by morphology or ≥1% blasts flow cytometry in the blood. * Presence of KMT2A rearrangement (KMT2Ar), NUP98 rearrangement (NUP98r), |
| Ages | 1 Year to 30 Years |
| Sex | All |
| Lead sponsor | St. Jude Children's Research Hospital |
| Locations | San Diego, California, United States; Aurora, Colorado, United States; Atlanta, Georgia, United States; Kansas City, Missouri, United States; New York, New York, United States; Cincinnati, Ohio, United States (+4 more sites) |
| Start date | 2024-04-19 |
| NCT ID | NCT06177067 |
| Official listing | https://clinicaltrials.gov/study/NCT06177067 |