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

Launched by TECHNISCHE UNIVERSITÄT DRESDEN · Dec 4, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called Ivosidenib for patients with Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Neoplasia (MDS) who have a specific genetic change known as an IDH1 mutation. The study focuses on patients who have recently received an allogeneic stem cell transplant, which is a procedure where healthy stem cells from a donor are given to replace unhealthy ones. The goal is to see if taking Ivosidenib after the transplant can help keep the cancer from coming back.

To be eligible for this trial, patients must have AML or MDS with the IDH1 mutation. However, individuals who have severe graft-versus-host disease (a condition where the donor's immune cells attack the recipient's body) that requires high doses of steroids are not allowed to participate. This study is not yet recruiting participants, and it aims to include individuals aged between 18 and 75. If you or someone you know is considering this trial, it’s important to discuss it with a healthcare provider to understand the potential benefits and risks.

Gender

ALL

Eligibility criteria

• 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