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Taking people in GermanyPhase 2

Tests ivosidenib after stem cell transplant in IDH1-mutated leukemia

Tests ivosidenib as maintenance after transplant in adults with IDH1-mutated AML or MDS.

Plain-language title generated from the registry record
Registry title: 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

Key facts

Where
Aachen, Chemnitz, Dresden, Erlangen, Essen, Frankfurt Am Main, Greifswald, Halle (Saale), Hamburg, Jena, Kiel, Leipzig, Mainz, Mannheim, Muenster, Munich, Oldenburg, Rostock, and Ulm, GermanySee the 19 sites
Phase
Phase 2

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Source: NCT06717958, who can take part

Where in Germany

  • Universitaetsklinikum Aachen AöRAachen, GermanyTaking people
  • Klinikum Chemnitz gGmbHChemnitz, GermanyTaking people
  • Technische Universitaet DresdenDresden, GermanyTaking people
  • Universitaetsklinikum Erlangen AöRErlangen, GermanyTaking people
  • Universitaetsklinikum Essen (AoR)Essen, GermanyTaking people
  • Goethe University FrankfurtFrankfurt Am Main, GermanyTaking people
  • Universitaetsmedizin Greifswald KöRGreifswald, GermanyTaking people
  • Martin-Luther-Universitaet Halle-WittenbergHalle (Saale), GermanyTaking people
  • University Medical Center Hamburg-EppendorfHamburg, GermanyTaking people
  • Universitaetsklinikum Jena KöRJena, GermanyTaking people
  • Universitaetsklinikum Schleswig-Holstein AöRKiel, GermanyTaking people
  • Universitaet LeipzigLeipzig, GermanyTaking people
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöRMainz, GermanyTaking people
  • Heidelberg UniversityMannheim, GermanyTaking people
  • Universitaet MuensterMuenster, GermanyTaking people
  • Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)Munich, GermanyTaking people
  • Klinikum Oldenburg AorOldenburg, GermanyTaking people
  • Rostock University Medical CenterRostock, GermanyTaking people
  • Universitaetsklinikum Ulm AoRUlm, GermanyTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Technische Universität Dresden
Trial code
NCT06717958EU 2023-509055-14-00
Record updated
26 August 2026
Original description
maintenance of AML or MDS patients with known IDH1 mutation after allogeneic stem cell transplantation within past 100 daysRead full original descriptionShow less

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

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

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

Inclusion criterion:; AML or MDS with IDH1 mutation.

ClinicalTrials.gov NCT06717958 · EU CTIS 2023-509055-14-00