M.D. Anderson Cancer Center
The goal of Phase 1a of this clinical research study is to find the highest tolerable dose of revumenib that can be given in combination with cytarabine, daunorubicin, and gemtuzumab ozogamicin to patients who have acute leukemia. The goal of Phase 1b of this clinical research study is to learn if the dose of revumenib in combination with cytarabine, daunorubicin, and gemtuzumab ozogamicin found in Phase 1a can help to control the disease.
Primary Objective: To determine the safety, tolerability and recommended phase II dose (RP2D) of Revumenib incombination with cytarabine and daunorubicin and Gemtuzumab ozogamicin (GO) in relapsed refractory and frontline pediatric patients with acute leukemias, with primary endpoint defined as DLT (per Section 7.5) Secondary Objective: To determine the preliminary assessment of efficacy by overall response (OR), including complete remission (CR), CR with incomplete blood count recovery and partial remission, overall survival (OS), event-free survival (EFS) and duration of response (DOR) of…
Inclusion Criteria: 1. Age . 6 months - 21 years of age. 2. ECOG performance status of \< 2. 3. Phase 1a portion of the study: Relapsed/refractory AML, or MPAL per ELN/NCCN with a myeloid phenotype with KMT2Ar, NPM1c, NUP98r and UBTF-ITD. 4. Phase 1b portion of the study: Frontline AML, or MPAL per ELN/NCCN with a myeloid phenotype with KMT2Ar, NUP98r and UBTF-ITD. 5. WBC must be below 25,000/ ƒÊL at time of enrollment. Patients may receive cytoreduction prior to enrollment. 6. Baseline ejection fraction must be \> 50%. 7. Adequate hepatic function (direct bilirubin \< 2x upper limit of norma…
Given by IV
Given by IV
Given by IV
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