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RECRUITING
NCT07607418
PHASE2

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

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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.

Official title: A Phase II, Multicenter, Open-label Clinical Study of Ivosidenib as Maintenance Therapy in Patients With IDH1-mutated AML and High-risk MDS Who Are Ineligible for Transplantation (IVORY-MAST)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-05-22

Completion Date

2027-12-30

Last Updated

2026-05-26

Healthy Volunteers

No

Interventions

DRUG

Ivosidenib

Ivosidenib: 500 mg, PO, QD, 28-day cycles

Locations (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, China