Decitabine Alone or in Combination With Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib as Maintenance Therapy for the Treatment of Acute Myeloid Leukemia in Remission

This phase Ib trial is to find out the side effects and possible benefits of decitabine alone or given together with venetoclax, gilteritinib, enasidenib, or ivosidenib in treating patients with acute myeloid leukemia that is under control (remission). Chemotherapy drugs, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax may stop the growth of cancer cells by blocking a protein called Bcl-2 needed for cell growth. Gilteritinib, enasidenib, and ivosidenib may

Trial Details

NCT ID
NCT05010772
Phase
PHASE1
Sponsor
M.D. Anderson Cancer Center
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Decitabine and Cedazuridine
  • Enasidenib
  • Gilteritinib
  • Ivosidenib
  • Venetoclax
Locations (sample)
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Patients aged \>= 18 years AML who have achieved their FIRST complete response (CR) or complete response with incomplete bone marrow recovery (CRi)…
  • Patients who have received intensive therapy (defined as receiving standard or higher dose cytarabine-based therapy) to achieve remission (CR/CRi) …
  • Patients who have received lower intensity therapy (defined as receiving low-dose cytarabine \[LDAC\] or hypomethylating agent \[HMA\]-based therap…
  • For either subgroup (lower or higher intensity), patients who have measurable residual disease may be enrolled on their respective cohort at any ti…

For full eligibility, visit ClinicalTrials.gov.

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