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

The goal of this clinical trial is to learn if the combination of oral decitabine plus ivosidenib works to treat naïve adult patients with acute myeloid leukemia (AML) with IDH1 R132 mutation older than 60 years old or those who are older than 18 years old with defined comorbidities that make them not suitable for standard induction therapy. The main objectives of this clinical trial are: * Asses the Complete Remission (CR) and Complete Remission with incomplete marrow recovery (CRi) rates of this treatment. * Determine the incidence and severity of all adverse events (AEs). All participants will receive oral ivosidenib and oral decitabine in treatment cycles of 28 days until disease progression, lack of clinical benefit or the end of the study. Patients who achieve CR/CRi will be elegible to receive allogeneic stem cell transplantation.

NCT Number	NCT07507760
Lead Sponsor	PETHEMA Foundation
Conditions	Acute Myeloid Leukemia With Gene Mutations
Enrollment	50 participants
Start Date	2026-06-12
Primary Completion	2029-04 (estimated)
Study Completion	2029-04 (estimated)
Updated on ClinicalTrials.gov	2026-07-29