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)

Study 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.

Primary Outcome

Defined as: 1) second occurrence of any of disease progression, relapse, failure to achieve complete remission (CR)/complete remission with hematologic improvement (CRh)/complete remission with incomplete blood count recovery (CRi), or 2) death from any cause. Within each treatment sequence, overall treatment failure rate will be defined as the number of patients with events divided by the number of eligible patients randomized. Patients who go to transplant will be considered a treatment succes

Conditions Studied

Interventions

• DRUG Venetoclax
• PROCEDURE Biopsy
• DRUG Azacitidine
• DRUG Ivosidenib
• DRUG Enasidenib

Study Locations (1)