A Phase I-II Study Investigating the All Oral Combination of the Menin Inhibitor SNDX-5613 With Decitabine/Cedazuridine (ASTX727) and Venetoclax in Acute Myeloid Leukemia (SAVE)
M.D. Anderson Cancer Center
Summary
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
Description
Primary Objectives: Phase Ib • To determine the safety, tolerability and recommended phase II dose (RP2D) of SNDX-5613 in combination with oral decitabine/cedazuridine (ASTX727) and venetoclax for patients with acute myeloid leukemia (AML). Phase II • To assess the efficacy of SNDX-5613 in combination with ASTX727 and venetoclax for patients with AML. Secondary Objectives • To assess overall survival, event-free survival and duration of response. Exploratory Objectives • To evaluate molecular and cellular markers that may be predictive of antitumor activity and/or resistance.
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Age ≥ 12 years with weight ≥ 40Kg. 2. ECOG performance status of ≤ 2. 3. 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. 4. WBC must be below 25,000/ μL at time of enrollment. Patients may receive cytoreduction prior to enrollment. 5. Baseline ejection fraction must be \> 40%. 6. Adequate hepatic function (direct bilirubin \< 2x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic inv…
Interventions
- DrugSNDX-5613
Given by PO
- DrugVenetoclax
Given by PO
- DrugASTX727
Given by PO
Location
- M D Anderson Cancer CenterHouston, Texas