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).
Age ≥ 2 year to 21 years
ECOG performance status of ≤ 2.
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
WBC must be below 25 K/µL at time of enrollment. Participants may receive cytoreduction prior to enrollment.
Participants who weigh less than 10kg.
Participants with any concurrent uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the patient at unacceptable risk of study treatment.
The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions (1) intrathecal chemotherapy for prophylactic use or for controlled CNS leukemia. (2) use of hydroxyurea for patients with rapidly proliferative disease or for control of counts during differentiation syndrome. (3) use of steroids for treatment of differentiation syndrome.
Participants with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.
Single group
Ziftomenib
DrugGiven by IV
Venetoclax
DrugGiven by PO
Azacitidine
DrugGiven by PO
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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M.D. Anderson Cancer Center
Lead sponsor
Kura Oncology, Inc.
Collaborator
