NCT05030441

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Clonal Cytopenia of Undetermined Significance

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-04-01
• Primary completion: 2030-01-31
• Completion: 2030-01-31
• First posted: 2021-09-01
• Last updated: 2025-08-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study