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
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
maintenance of AML or MDS patients with known IDH1 mutation after allogeneic stem cell transplantation within past 100 days
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• AML or MDS with IDH1 mutation
Locations
Other Locations
Germany
Universitätsklinikum Aachen
NOT_YET_RECRUITING
Aachen
Technische Universitaet Dresden, Medizinische Klinik und Poliklinik I
NOT_YET_RECRUITING
Dresden
Universitätsklinikum Essen
NOT_YET_RECRUITING
Essen
Martin-Luther-Universitaet Halle-Wittenberg
RECRUITING
Halle
University Medical Center Hamburg-Eppendorf
NOT_YET_RECRUITING
Hamburg
Universitätsklinikum Jena
NOT_YET_RECRUITING
Jena
Universitätsklinikum Schleswig-Holstein
RECRUITING
Kiel
Universität Leipzig
NOT_YET_RECRUITING
Leipzig
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
NOT_YET_RECRUITING
München
Universität Münster
NOT_YET_RECRUITING
Münster
Rostock University Medical Center
NOT_YET_RECRUITING
Rostock
Universitaetsklinikum Ulm
NOT_YET_RECRUITING
Ulm
Contact Information
Primary
Jan Moritz Middeke, Dr. med.
pivot@ukdd.de
+493514583192
Backup
Friedrich Stölzel, Prof. Dr. med.
pivot@ukdd.de
+493514583192
Time Frame
Start Date: 2025-06-17
Estimated Completion Date: 2030-02-01
Participants
Target number of participants: 76
Treatments
Experimental: Ivosidenib
Related Therapeutic Areas
Sponsors
Leads: Technische Universität Dresden