NCT07075016

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 227 (estimated)
• Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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'.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Venetoclax 400	day 1-28 per cycle
DRUG	Placebo	day 1-28 per cycle

Timeline

• Start date: 2025-08-05
• Primary completion: 2028-12-01
• Completion: 2029-03-01
• First posted: 2025-07-20
• Last updated: 2025-08-19

Locations

119 sites across 16 countries: Austria, Belgium, Denmark, Estonia, Finland, France, Germany, Ireland, Italy, Lithuania, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom