M.D. Anderson Cancer Center
To find the recommended dose of ziftomenib in combination with gemtuzumab ozogamicin and venetoclax that can be given to pediatric participants who have relapsed or refractory AML or MPAL.
Primary Objectives: \- To determine the safety, tolerability, and recommended Phase II dose (RP2D) of ziftomenib in combination with gemtuzumab ozogamicin and venetoclax for pediatric participants with acute myeloid leukemia (AML). Secondary Objectives: * 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 pediatric participants treated with this combination. * To determine time to first…
Inclusion Criteria: 1. Age ≥ 3 year to 21 years 2. Karnofsky for children \>16yo and Lansky \<16yo. 3. Relapsed/refractory AML, or MPAL with a myeloid phenotype. 1. Evidence of leukemia (AML, MPAL with a myeloid phenotype) in the bone marrow as detected by morphology or molecular diagnostics. 2. Presence of KMT2Ar, NUP98r, NPM1c, UBTF-ITD or other HOX pathway mutation. 4. WBC must be below 25,000/ƒÊL 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 uppe…
Given by PO
Given by IV
Given by PO
Arctuva estimate
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