M.D. Anderson Cancer Center
To find the highest safe dose of ziftomenib that can be combined with venetoclax and azacitidine in pediatric participants with acute leukemia that has certain types of genetic mutations (changes).
Primary Objectives - To determine the safety, tolerability, and recommended Phase II dose (RP2D) of ziftomenib in combination with venetoclax and azacitidine for pediatric participants with acute leukemias with KMT2A-r, NPM1-m, NUP98-r, or HOX pathway mutations. Secondary Objectives \- To determine the preliminary assessment of efficacy by overall response (OR), including complete remission (CR), CR with partial hematological recovery (CRh), CR with incomplete blood count recovery (CRi), morphological leukemia-free state (MLFS) and partial remission (PR), overall survival (OS), event-free su…
Inclusion Criteria: 1. Age ≥ 2 year to 21 years 2. ECOG performance status of ≤ 2. 3. Relapsed/refractory: AML60, Mixed phenotype acute leukemia61 (MPAL), ALL61, Acute leukemia of ambiguous lineage (ALAL)62 patients with KMT2A-r, NPM1-m, NUP98-r, or HOX pathway mutation as detailed in background section a. ≥5% leukemic blasts in the bone marrow: 4. WBC must be below 25 K/µL at time of enrollment. Participants may receive cytoreduction prior to enrollment. 5. Baseline ejection fraction must be \> 40%. 6. Adequate hepatic function (direct bilirubin \< 1.5x upper limit of normal (ULN) unless…
Given by IV
Given by PO
Given by PO
Arctuva estimate
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