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

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

Determination of the efficacy of Ivosidenib to improve event-free survival when given as maintenance therapy following alloSCT.

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