Revumenib in Combination With 7+3 + Midostaurin in AML
This research is being conducted to determine a safe and effective dose of revumenib that can be given in combination with standard induction (initial therapy to induce a remission) + FLT3 targeted therapy (midostaurin) and a single cycle of post-remission therapy + FLT3 targeted therapy (midostaurin) to participants w
| Condition(s) | Acute Myeloid Leukemia, AML, Adult, AML With Gene Mutations, AML, Leukemia |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This research is being conducted to determine a safe and effective dose of revumenib that can be given in combination with standard induction (initial therapy to induce a remission) + FLT3 targeted therapy (midostaurin) and a single cycle of post-remission therapy + FLT3 targeted therapy (midostaurin) to participants with newly diagnosed Nucleophosmin (NPM1) and FMS-like tyrosine kinase 3 (FLT3) mutated Acute Myeloid Leukemia (AML). The names of the study drugs involved in this study are: * Revumenib (SNDX-5613) (a type of menin inhibitor) * Midostaurin (a type of multi-kinase including FLT3 inhibitor) * Cytarabine (a type of antineoplastic agent) * Daunorubicin (a type of antineoplastic agent) |
| Who can participate | Inclusion Criteria: * Patients with AML who are newly diagnosed according to the WHO 2022 Classification and previously untreated except for hydroxyurea. ATRA pretreatment for suspected APL for less than 5 days is allowed. Eligible patients with AML arising from an antecedent hematologic disease (AHD) including MDS, may have been treated for their prior hematologic disease (except for allogenic transplant). * Patients must be ≥ 18 and \< 75 years old. * Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2. * Presence of FLT3-ITD and/or TKD mutation(s) AND NPM1 mutation in bone marrow or peripheral blood * Dose escalation phase only: Presence of any of the following adverse risk genetic characteristics: * 2022 ELN adverse risk genetic features: * t(6;9)(p23.3;q34.1)/DEK::N |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Richard Stone, MD |
| Locations | New Haven, Connecticut, United States; Boston, Massachusetts, United States |
| Start date | 2024-12-06 |
| NCT ID | NCT06313437 |
| Official listing | https://clinicaltrials.gov/study/NCT06313437 |