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

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called ivosidenib can help prevent leukemia from coming back in patients who have already received a stem cell transplant. Ivosidenib targets a specific gene mutation (IDH1) that drives certain blood cancers. **You may be eligible if...** - You have acute myeloid leukemia (AML) or a high-risk blood disorder called myelodysplastic syndrome (MDS) - Your cancer has the IDH1 gene mutation - You have already had an allogeneic stem cell transplant (a transplant using a donor's stem cells) **You may NOT be eligible if...** - You are currently experiencing severe graft-versus-host disease (a condition where donor cells attack your body), specifically grade III-IV severity requiring high-dose steroids Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIvosidenib 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

View Full Details on ClinicalTrials.gov

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NCT06717958

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