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)

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

Trial Details

NCT ID
NCT05360160
Phase
PHASE1 / PHASE2
Sponsor
M.D. Anderson Cancer Center
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • SNDX-5613
  • Venetoclax
  • ASTX727
Locations (sample)
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • 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 myelo…
  • WBC must be below 25,000/ μL at time of enrollment. Patients may receive cytoreduction prior to enrollment.

For full eligibility, visit ClinicalTrials.gov.

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