drugset / Trial / NCT05030441
Ivosidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH1
Phase 2
Active not recruiting
20 enrolled
Washington University School of Medicine
Gateway for Cancer Research · collabServier Hellas Pharmaceuticals Ltd. · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2022-04-01
- Primary completion
- 2030-01-31
- Completion
- 2030-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ivosidenib | Small molecule | 500 mg | Oral |