Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome

This phase II trial studies the side effects and how well azacitidine and enasidenib work in treating patients with IDH2-mutant myelodysplastic syndrome. Azacitidine and enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Trial Details

NCT ID
NCT03383575
Phase
PHASE2
Sponsor
M.D. Anderson Cancer Center
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Azacitidine
  • Enasidenib
  • Quality-of-Life Assessment
Locations (sample)
  • Baltimore, Maryland, United States|39.29038,-76.61219
  • Cleveland, Ohio, United States|41.4995,-81.69541
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Signed, informed consent must be obtained prior to any study specific procedures
  • Subjects with a histologically confirmed diagnosis of MDS, including both MDS and refractory anemia with excess blasts in transformation (RAEB-T) (…
  • Subjects must have an IDH2 gene mutation (IDH2-R140 or R172) as determined by local laboratory result
  • (Arm A only): Subject must be hypomethylating agent naive (i.e. prior azacitidine, decitabine, SGI-110 is exclusionary). Receipt of other MDS-direc…

For full eligibility, visit ClinicalTrials.gov.

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