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NCT05030441 · ClinicalTrials.gov registry record · Phase 2
Ivosidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH1
A Phase 2 study of Clonal Cytopenia of Undetermined Significance, sponsored by Washington University School of Medicine.
- Active
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT05030441: Active Phase 2 study of Clonal Cytopenia of Undetermined Significance, sponsored by Washington University School of Medicine.
NCT05030441 is a Phase 2 study of Clonal Cytopenia of Undetermined Significance that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 20 participants, below the 435-participant average among 11 other Clonal Cytopenia of Undetermined Significance trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05030441, a Phase 2 study of Clonal Cytopenia of Undetermined Significance, is active but no longer recruiting, sponsored by Washington University School of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
Will be evaluated according to a modified version of the IWG 2006 Criteria for Hematologic Improvement for patients with MDS on clinical trials * Erythroid response (pretreatment, \<11 g/DL) * Hemoglobin (Hgb) increase by ≥1.5 g/dL * Relevant reduction of units of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 weeks, compared with the pretreatment transfusion number in the previous 8 weeks. Only RBC transfusions given for an Hgb of ≤9.0 g/dL pretreatment will count
Conditions Studied
Interventions
- DRUG Ivosidenib
Study Locations (2)
Missouri
- Washington University School of Medicine - St Louis
Ohio
- Cleveland Clinic - Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-04-01 |
| Est. Completion | 2030-01-31 |
| Phase | Phase 2 |
What the registry record for NCT05030441 still lists
NCT05030441 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 435-participant average among 11 other Clonal Cytopenia of Undetermined Significance trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Clonal Cytopenia of Undetermined Significance appearing as the primary indexed condition, and to 1 intervention - of which Ivosidenib is the first listed.
NCT05030441 reports a single indexed study location in Missouri, Ohio.
Frequently Asked Questions
What is clinical trial NCT05030441 about?
NCT05030441 is a clinical study titled "Ivosidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH1". 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 ...
What is the current status of trial NCT05030441?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2022-04-01. Estimated completion is 2030-01-31.
What conditions does trial NCT05030441 study?
This clinical trial studies the following conditions: Clonal Cytopenia of Undetermined Significance.
What interventions are being tested in trial NCT05030441?
The interventions under investigation include: Ivosidenib (DRUG).
Who is sponsoring clinical trial NCT05030441?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05030441 being conducted?
This trial has 2 study locations across Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05030441's enrollment target sits among peer trials
20 9th of 11 higher than 3 of 11 other Clonal Cytopenia of Undetermined Significance trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clonal Cytopenia of Undetermined Significance trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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