drugset / Trial / 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
Phase 3
Recruiting
227 enrolled
HOVON Foundation
Danish Acute Leukemia Group · collabGerman-Austrian Acute Myeloid Leukemia Study Group · collabGrupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias · collabGruppo Italiano Malattie EMatologiche dell'Adulto · collabNordic AML Group · collabSwiss Group for Clinical Cancer Research (SAKK) · collabUnited Kingdom AML Research Network · collab
RandomizedSingle-groupTriple-blindTreatment
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'.
Timeline
- Start
- 2025-08-05
- Primary completion
- 2028-12
- Completion
- 2029-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Venetoclax | Small molecule | 400 unknown | — |