Ivosidenib and Azacitidine With or Without Venetoclax in Adult Patients With Newly Diagnosed IDH1-Mutated AML or MDS/AML Considered Ineligible for Intensive Chemotherapy

The standard treatment for patients with acute myeloid leukemia (AML) with an abnormality in the IDH1 gene, who are not eligible for intensive chemotherapy, is a combination of ivosidenib and azacitidine. In this study it is investigated whether adding venetoclax to the standard treatment can improve the outcome of the treatment of this specific form of AML. The safety is investigated and how well it works. In order to properly assess the value of venetoclax, the effect of venetoclax is compared with the effect of a placebo. A placebo is a product without an active ingredient, a 'fake medicinal product'.

NCT Number	NCT07075016
Lead Sponsor	Stichting Hemato-Oncologie voor Volwassenen Nederland Collaborators: German-Austrian Acute Myeloid Leukemia Study Group, United Kingdom AML Research Network, Gruppo Italiano Malattie EMatologiche dell'Adulto, Swiss Group for Clinical Cancer Research (SAKK), Danish Acute Leukemia Group, Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias, Nordic AML Group
Conditions	Acute Myeloid Leukemia
Enrollment	227 participants
Start Date	2025-08-05
Primary Completion	2028-12 (estimated)
Study Completion	2029-03 (estimated)
Updated on ClinicalTrials.gov	2025-08-19