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Recruiting Phase 2 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
Trial Parameters
Condition AML
Sponsor Technische Universität Dresden
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 76
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2025-06-17
Completion 2029-10-01
Interventions
Ivosidenib 250 MG (milligram)
Brief Summary
maintenance of AML or MDS patients with known IDH1 mutation after allogeneic stem cell transplantation within past 100 days
Eligibility Criteria
Inclusion criterion: * AML or MDS with IDH1 mutation Exclusion criteria: * active GvHD (graft vs host disease) grade III-IV according to Harris criteria requiring steroids \>1mg/ kg prednisolone equivalent