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

NCT05030441 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-08-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Servier Hellas Pharmaceuticals Ltd.

    collaborator INDUSTRY

  • Gateway for Cancer Research

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Kelly Bolton, M.D., Ph.D. · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2030-01-31
Completion
2030-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05030441 on ClinicalTrials.gov