NCT06717958

Prospective Evaluation of Ivosidenib Maintenance Following Allogeneic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Neoplasia With IDH1 (Isocitrate Dehydrogenase 1) Mutation

A Prospective, Single-arm, Open-label, Multicenter Phase II Trial Evaluating the Efficacy and Safety of Ivosidenib Maintenance Therapy After Allogeneic Stem Cell Transplantation (alloSCT) in Patients With Acute Myeloid Leukemia (AML) and Myelodysplastic Neoplasia (MD) Carrying an IDH1 Mutation

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

maintenance of AML or MDS patients with known IDH1 mutation after allogeneic stem cell transplantation within past 100 days

Detailed description

Determination of the efficacy of Ivosidenib to improve event-free survival when given as maintenance therapy following alloSCT.

Conditions

• AML
• MDS

Interventions

Type	Name	Description
DRUG	Ivosidenib 250 MG (milligram)	oral

Timeline

• Start date: 2025-06-17
• Primary completion: 2029-10-01
• Completion: 2030-02-01
• First posted: 2024-12-05
• Last updated: 2025-07-02

Locations

12 sites across 1 country: Germany