RecruitingPhase 2NCT06717958

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

Sponsor

Technische Universität Dresden

Enrollment

76 participants

Start Date

Jun 17, 2025

Study Type

INTERVENTIONAL

Conditions

AML MDS

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria2

Inclusion criterion:
AML or MDS with IDH1 mutation

Exclusion Criteria1

active GvHD (graft vs host disease) grade III-IV according to Harris criteria requiring steroids \>1mg/ kg prednisolone equivalent

Interventions

DRUGIvosidenib 250 MG (milligram)

oral

Locations(12)

Universitätsklinikum Aachen

Aachen, Germany

Technische Universitaet Dresden, Medizinische Klinik und Poliklinik I

Dresden, Germany

Universitätsklinikum Essen

Essen, 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

Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)

München, Germany

Universität Münster

Münster, Germany

Rostock University Medical Center

Rostock, Germany

Universitaetsklinikum Ulm

Ulm, Germany

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NCT06717958

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