Overview

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

Status:
RECRUITING

Trial end date:
2029-03-01

Target enrollment:

Participant gender:

Summary

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'.

Phase:

PHASE3

Details

Lead Sponsor:

Stichting Hemato-Oncologie voor Volwassenen Nederland

Collaborators:

Danish Acute Leukemia Group
German-Austrian Acute Myeloid Leukemia Study Group
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA)
Nordic AML Group
Swiss Group for Clinical Cancer Research (SAKK)
United Kingdom AML Research Network