Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial)

This phase II MyeloMATCH treatment trial studies how well ASTX727 and venetoclax plus enasidenib works compared to ASTX727 and venetoclax alone for the treatment of older patients with newly diagnosed acute myeloid leukemia (AML) or younger patients who are considered unfit for standard treatment, and who have an abnormal change (mutation) in the IDH2 gene. This gene mutation can cause AML to grow and spread. This trial is being done to see if adding enasidenib to the usual treatment can help more patients with the IDH2 gene get rid of AML. ASTX727 is a fixed-dose formulation of two drugs, ce

Trial Details

NCT ID
NCT06672146
Phase
PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Biospecimen Collection
  • Bone Marrow Aspiration
  • Bone Marrow Biopsy
  • Decitabine and Cedazuridine
  • Enasidenib
  • Venetoclax
Locations (sample)
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Berkeley, California, United States|37.87159,-122.27275
  • San Francisco, California, United States|37.77493,-122.41942

Key Eligibility Criteria

  • Participants must have been registered to the MYELOMATCH Master Screening and Reassessment Protocol prior to consenting to this study. Participants…
  • Note: Pre-enrollment/diagnosis labs must have already been performed under MYELOMATCH
  • Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) defined by having ≥ 20% blasts in the bone marrow and/or peripheral …
  • Participants must not be receiving or planning to receive any other investigational agents while on protocol therapy

For full eligibility, visit ClinicalTrials.gov.

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