protocolSection identificationModule nctId: NCT06313437, orgStudyIdInfo id: 24-021, briefTitle: Revumenib in Combination With 7+3 + Midostaurin in AML, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2026-03-02, completionDateStruct date: 2027-03-02, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Maximilian Stahl, MD, class: OTHER, collaborators name: Syndax Pharmaceuticals, descriptionModule briefSummary: 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), conditionsModule conditions: Acute Myeloid Leukemia, conditions: AML, Adult, conditions: AML With Gene Mutations, conditions: AML, conditions: Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: Revumenib, interventions name: Midostaurin, interventions name: Cytarabine, interventions name: Daunorubicin, outcomesModule primaryOutcomes measure: Number of Participants Experiencing Dose Limiting Toxicity (DLT), primaryOutcomes measure: Maximum Tolerated Dose (MTD), primaryOutcomes measure: Recommended phase II dose (RP2D), secondaryOutcomes measure: Complete Remission (CR) rate with induction chemotherapy, secondaryOutcomes measure: Complete Remission (CR) rate with consolidation chemotherapy, secondaryOutcomes measure: Flow Measurable Residual Disease Negative (MRD-) rate with induction chemotherapy, secondaryOutcomes measure: Flow Measurable Residual Disease Negative (MRD-) rate with consolidation chemotherapy, secondaryOutcomes measure: Molecular Measurable Residual Disease Negative (MRD-) rate with induction chemotherapy, secondaryOutcomes measure: Molecular Measurable Residual Disease Negative (MRD-) rate with consolidation chemotherapy, secondaryOutcomes measure: Relapse-Free Survival at 1 year (RFS1), secondaryOutcomes measure: Overall Survival at 1 year (OS1), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, city: Boston, state: Massachusetts, zip: 02215, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Dana-Farber Cancer Institute, city: Boston, state: Massachusetts, zip: 02215, country: United States, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False