Ivosidenib or Enasidenib Followed by Azacitidine Plus Venetoclax or Azacitidine Plus Venetoclax Followed by Ivosidenib or Enasidenib for the Treatment of IDH Mutated Acute Myeloid Leukemia in Older Patients. The I-DATA Study

• Status: Not yet recruiting
• Trial end date: 2024-12-31

Summary

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. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells. This study may help researchers determine which treatment order is best for older patients with IDH mutated acute myeloid leukemia: 1) ivosidenib or enasidenib followed by azacitidine plus venetoclax; or 2) azacitidine plus venetoclax followed by ivosidenib or enasidenib.

• Phase: Phase 2

Details

• Lead Sponsor: Alice Mims
• Treatments: Azacitidine; Ivosidenib; Venetoclax