ALIDHE phase 3b study design: ivosidenib + azacitidine in adults with newly diagnosed IDH1 mutant acute myeloid leukemia
Year: 2025
Type: article
Study design: Study Protocol
Abstract: INTRODUCTION: Ivosidenib is an inhibitor of mutant isocitrate dehydrogenase 1 (mIDH1) that is approved alone or in combination with azacitidine in patients with mIDH1 acute myeloid leukemia (AML) that are ineligible to receive intensive chemotherapy. AIMS: Here we describe the design of ALIDHE, an international, multicenter, single-arm, open-label Phase 3b study of ivosidenib + azacitidine for treatment of newly diagnosed mIDH1 AML in usual clinical practice. METHODS: The primary endpoints are adverse events (AEs), clinical laboratory anomalies assessed as AEs, patients requiring transfusion and number of units transfused, and infection rate. The impact of ivosidenib + azacitidine treatment on health-related quality of life, healthcare resource utilization and measurable residual disease will also be assessed. CLINICAL TRIAL REGISTRATION NUMBER: NCT05907057 (ClinicalTrials.gov).
Source: Future Oncology
Authors: Paresh Vyas, Sam Salek, Susana Vives, Christian Recher, Hartmut Döhner, Adriano Venditti, Hélène Derrien, Stéphanie Chatin, Anne-Marie De La Bigne, Jana Pelouchova, Ralph Hills, Samantha Nier
Institutions: University of Oxford, MRC Weatherall Institute of Molecular Medicine, MRC Molecular Haematology Unit, University of Hertfordshire, Universitat Autònoma de Barcelona, Hospital Universitari Germans Trias i Pujol, Université Toulouse III - Paul Sabatier, Centre Hospitalier Universitaire de Toulouse, Centre de Recherches en Cancérologie de Toulouse, Institut universitaire du cancer de Toulouse Oncopole, Universität Ulm, University Hospital Ulm, University of Rome Tor Vergata, Servier (France)
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Funder: Servier
OpenAlex ID: W4416265236