Part 1b of this clinical research study is to find the highest tolerable dose of SNDX-5613 that can be given in combination with ASTX727 (a combination of the drugs decitabine/cedazuridine) and venetoclax for patients with acute myeloid leukemia (AML) or those with a mixed phenotype acute leukemia with a myeloid phenotype (MPAL).
Part 2 of this study is to learn if the dose of study drugs found in Part 1b can help to control AML/MPAL
Age ≥ 12 years with weight ≥ 40Kg.
ECOG performance status of ≤ 2.
Newly diagnosed (frontline cohort), who are not eligible for high-intensity induction chemotherapy or relapsed/refractory (R/R cohort) AML or myeloid phenotype MPAL with either KMT2Ar, or NUP98r, or NPM1c.
WBC must be below 25,000/ μL at time of enrollment. Patients may receive cytoreduction prior to enrollment.
Prior treatment with a menin inhibitor.
Patients 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.
Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.
M.D. Anderson Cancer Center
Lead sponsor
Astex Pharmaceuticals, Inc.
Collaborator
Syndax Pharmaceuticals
Collaborator