M.D. Anderson Cancer Center
The goal of this all-oral combination is to deliver safe and effective therapy for the largest portion of AML subtypes (NPM1mt, KMT2Ar, NUP98r \~ 40-45%).
Primary Objective: Cohort 1A: To determine the recommended phase 2 dose (RP2D) of ziftomenib in combination with quizartinib and assess the safety and the maximum tolerated dose (MTD). Secondary Objectives: To assess the preliminary efficacy of the combination of quizartinib and ziftomenib by FLT3 mutational status. To assess overall survival (OS), relapse-free survival (RFS), event-free survival (EFS) and duration of response (DOR). To characterize the pharmacokinetic profile of ziftomenib and quizartinib when used in combination. To assess minimal residual disease negativity by flow cy…
Inclusion Criteria: 1. Age . 18 years. 2. ECOG performance status of \< 2. 3. Relapsed or refractory AML or myeloid mixed-phenotype acute leukemia (MPAL) with NPM1mt, or KMT2Ar, or NUP98r. 4. WBC must be below 25,000/ ƒÊL at time of enrollment. Patients may receive cytoreduction prior to enrollment. 5. Baseline ejection fraction must be \> 40%. 6. Adequate hepatic function (total bilirubin \< 2x upper limit of normal (ULN) unless increase is due leukemic involvement (\<2.5 ULN), unless due to ongoing hemolysis or Gilbert's syndrome and AST and/or ALT \< 3x ULN unless considered due to leukemi…
Participants will receive treatment in tablet form
Participants will receive treatment in tablet form
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