Study of Oral Decitabine Plus Ivosidenib for Adults with Newly Diagnosed Acute Myeloid Leukemia Who Are Older Than 60 or Unfit for Standard Treatment

What this Trial Is About

Researchers are evaluating whether the combination of oral decitabine plus ivosidenib can treat adult patients with newly diagnosed acute myeloid leukemia AML who have the IDH1 R132 mutation. This study focuses on older adults over 60 years or adults over 18 years with certain health conditions that make them unsuitable for standard intensive chemotherapy. The trial aims to assess rates of complete remission and incomplete marrow recovery, as well as the frequency and severity of adverse events related to the treatment. Participants will receive treatment in 28-day cycles. Each cycle includes oral ivosidenib 500 mg daily for 28 days and oral decitabine-cedazuridine tablets on days 1 through 5. During screening and the first two treatment cycles, hydroxyurea or cytarabine may be used to control high white blood cell counts if needed. Patients who achieve remission may be eligible for an allogeneic stem cell transplant and can resume ivosidenib after 60 days post-transplant. The post-transplant treatment phase may last up to two years. During the study, participants will undergo regular assessments including monitoring for disease progression, side effects, and treatment response. Researchers will collect data on remission rates and adverse events for up to three years. Those undergoing stem cell transplants will have additional evaluations before and after transplant, including minimal residual disease status. Participant involvement may continue for the duration of the treatment cycles, transplant period, and follow-up visits, ending either with disease progression or study completion.

Oral Decitabine Plus Ivosidenib as First Line for Older/Unfit Adult AML Patients