Comparing ASTX727 and Venetoclax With or Without Enasidenib for Adults With Newly Diagnosed IDH2 Mutant Acute Myeloid Leukemia

What this Trial Is About

This trial investigates treatments for older adults newly diagnosed with acute myeloid leukemia AML who have a specific gene mutation called IDH2. It compares the combination of ASTX727 and venetoclax with or without the addition of enasidenib. The study aims to see if adding enasidenib helps more patients achieve remission by targeting the IDH2 mutation that contributes to leukemia growth. Participants are randomly assigned to one of two groups. One group receives ASTX727, an oral combination of cedazuridine and decitabine, plus venetoclax daily for 28 days in repeated 28-day cycles. The other group receives the same treatment with the addition of enasidenib every day in the cycle. Treatment continues unless the disease worsens or side effects become unacceptable. Throughout the trial, patients undergo blood and bone marrow tests to monitor their response. During the study, participants have regular blood sample collections, bone marrow aspirations, and biopsies to assess disease status and treatment effects. After completing treatment, follow-up visits occur monthly for the first year, then every two months in the second year, every three months in the third year, and every six months up to five years or until death. The main outcome measured is the rate of remission without detectable leukemia after two treatment cycles. Safety and long-term outcomes are also tracked.

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