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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
Sponsor: Technische Universität Dresden
Summary
maintenance of AML or MDS patients with known IDH1 mutation after allogeneic stem cell transplantation within past 100 days
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
76
Start Date
2025-06-17
Completion Date
2030-02-01
Last Updated
2026-08-26
Healthy Volunteers
No
Interventions
Ivosidenib 250 MG (milligram)
oral
Locations (17)
Universitätsklinikum Aachen
Aachen, Germany
Klinikum Chemnitz gGmbH
Chemnitz, Germany
Technische Universitaet Dresden, Medizinische Klinik und Poliklinik I
Dresden, Germany
Universitaetsklinikum Erlangen AöR
Erlangen, Germany
Universitätsklinikum Essen
Essen, Germany
Goethe Universität Frankfurt / Universitätsklinikum Frankfurt
Frankfurt am Main, Germany
Universitätsmedizin Greifswald KöR
Greifswald, Germany
Martin-Luther-Universitaet Halle-Wittenberg
Halle, Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Universitätsklinikum Jena
Jena, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Germany
Universität Leipzig
Leipzig, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
München, Germany
Universität Münster
Münster, Germany
Rostock University Medical Center
Rostock, Germany
Universitaetsklinikum Ulm
Ulm, Germany