Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

This phase Ib/II trials studies the side effects of decitabine/cedazuridine (ASTX727) and venetoclax in combination with ivosidenib or enasidenib, and how well they work in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). ASTX727 is the combination of a fixed dose of 2 drugs, cedazuridine and decitabine. Cedazuridine may slow down how fast decitabine is broken down by the body, and decitabine may block abnormal cells or cancer cells from growing. Venetoclax may stop the growth of cancer cells by blocking BCL-2, a protein

Trial Details

NCT ID
NCT04774393
Phase
PHASE1 / PHASE2
Sponsor
M.D. Anderson Cancer Center
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Decitabine and Cedazuridine
  • Enasidenib
  • Ivosidenib
  • Venetoclax
Locations (sample)
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Patients with a diagnosis of relapsed or refractory acute myeloid leukemia (AML) (including biphenotypic or bilineage leukemia including a myeloid …
  • Patients (\> 60 year old) with newly diagnosed AML not eligible for intensive chemotherapy are also eligible
  • To be considered not eligible for intensive chemotherapy, participants must be defined by the following: Age 75 years or older, or Age 18 to 74 yea…
  • Severe cardiac disorder (eg, congestive heart failure requiring treatment, ejection fraction ≤50%, or chronic stable angina).

For full eligibility, visit ClinicalTrials.gov.

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