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ACTIVE NOT RECRUITING
NCT05030441
PHASE2

Ivosidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH1

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

Summary

This is an open-label, multicenter study exploring the efficacy of ivosidenib in patients with clonal cytopenia of undetermined significance (CCUS) with mutations in IDH1. The purpose is to establish proof of principle that ivosidenib is well-tolerated and potentially efficacious in improving blood count abnormalities in these patients. The study will also be offered in a decentralized, remote structure to patients.

Official title: A Pilot Study of Ivosidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH1

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2022-04-01

Completion Date

2030-01-31

Last Updated

2025-08-14

Healthy Volunteers

No

Interventions

DRUG

Ivosidenib

. Patients should take ivosidenib at approximately the same time every day, with or without food, but should be instructed to avoid a high-fat meal as well as grapefruit and grapefruit products.

Locations (2)

Washington University School of Medicine

St Louis, Missouri, United States

Cleveland Clinic - Case Comprehensive Cancer Center

Cleveland, Ohio, United States