Ivosidenib maintenance after allogeneic stem cell transplant for IDH1‑mutant AML or high‑risk MDS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial gives oral ivosidenib 250 mg daily as maintenance to patients with IDH1‑mutated acute myeloid leukemia (AML) or high‑risk myelodysplastic neoplasia (MDS) who had an allogeneic stem cell transplant within the past 100 days. Participants are monitored regularly for relapse, adverse events, and graft‑versus‑host disease, and those with severe active GVHD requiring >1 mg/kg steroids are excluded. The primary endpoint is event‑free survival, with secondary endpoints including safety and tolerability. The study is led by Technische Universität Dresden with sites in Aachen, Dresden, and Essen, Germany.

Why it matters

Who can join: the full rules

Inclusion criterion:

* AML or MDS with IDH1 mutation

Exclusion criteria:

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

Where it's running

• Universitätsklinikum Aachen
  Aachen, Germany Recruiting
• Klinikum Chemnitz gGmbH
  Chemnitz, Germany Recruiting
• Technische Universitaet Dresden, Medizinische Klinik und Poliklinik I
  Dresden, Germany Recruiting
• Universitätsklinikum Essen
  Essen, Germany Recruiting
• Goethe Universität Frankfurt / Universitätsklinikum Frankfurt
  Frankfurt am Main, Germany Recruiting
• Universitätsmedizin Greifswald KöR
  Greifswald, Germany Recruiting

Study contacts

• Study coordinator: Jan Moritz Middeke, Dr. med.
• Email: pivot@ukdd.de
• Phone: +493514583192

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.