IDH Targeted/Non- Targeted vs Non-targeted/IDH-targeted Approaches in the Treatment of Newly Diagnosed IDH Mutated AML Patients Not Candidates for Intensive Induction Therapy (I- DATA Study)

This phase II study compares the order of treatment with ivosidenib or enasidenib and azacitidine plus venetoclax in treating older patients with acute myeloid leukemia with genetic changes in the IDH1 or IDH2 genes (IDH mutated). Ivosidenib is in a class of medications called isocitrate dehydrogenase-1 (IDH1) inhibitors. It works by slowing or stopping the growth of cancer cells. Enasidenib is in a class of medications called an IDH2 inhibitor. It also works by slowing or stopping the growth of cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors.

Trial Details

NCT ID
NCT05401097
Phase
PHASE2
Sponsor
Alice Mims
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Azacitidine
  • Biopsy
  • Enasidenib
  • Ivosidenib
  • Venetoclax
Locations (sample)
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Chapel Hill, North Carolina, United States|35.9132,-79.05584
  • Columbus, Ohio, United States|39.96118,-82.99879
  • Dallas, Texas, United States|32.78306,-96.80667

Key Eligibility Criteria

  • Patients with newly diagnosed IDH1 or IDH2 mutated AML
  • Not a candidate for or refuses intensive induction therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Creatinine clearance \> 40 ml/min

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Leukemia Trials on Trialify →