drugset / Trial / NCT07607418

Ivosidenib as Maintenance Therapy in Transplant-Ineligible IDH1-mutated AML and HR-MDS

NCT07607418

Phase 2 Recruiting 20 enrolled Ruijin Hospital
NaSingle-groupOpen-labelTreatment

Summary

This study will explore the efficacy and safety of ivosidenib as maintenance therapy in patients with IDH1-mutated AML and high-risk MDS who are ineligible for transplantation, along with accompanying molecular biomarker research. Patients who meet the eligibility criteria will receive ivosidenib treatment until disease progression or unacceptable toxicity. This study will provide an effective maintenance treatment option for transplant-ineligible patients with IDH1-mutated AML and high-risk MDS.

Timeline

Start
2026-05-22
Primary completion
2027-05-30
Completion
2027-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Ivosidenib Small molecule 500 mg Oral