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NCT03801434 · ClinicalTrials.gov registry record · Phase 2
Ruxolitinib in Treating Patients With Hypereosinophilic Syndrome or Primary Eosinophilic Disorders
A Phase 2 study of Hypereosinophilic Syndrome and Blasts More Than 5 Percent of Bone Marrow Nucleated Cells, sponsored by William Shomali.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 4
- Study locations
NCT03801434: Recruiting Phase 2 study of Hypereosinophilic Syndrome and Blasts More Than 5 Percent of Bone Marrow Nucleated Cells, sponsored by William Shomali.
NCT03801434 is a Phase 2 study of Hypereosinophilic Syndrome and Blasts More Than 5 Percent of Bone Marrow Nucleated Cells that is actively recruiting participants, run by William Shomali. The registered enrollment target is 10 participants, below the 132-participant average among 7 other Hypereosinophilic Syndrome trials with a reported enrollment target (92% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03801434, a Phase 2 study of Hypereosinophilic Syndrome and Blasts More Than 5 Percent of Bone Marrow Nucleated Cells, is actively recruiting participants, sponsored by William Shomali.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 4
- Study locations
Study Summary
This phase II trial studies how well ruxolitinib works in treating patients with hypereosinophilic syndrome or primary eosinophilic disorders.
Primary Outcome
ORR is the sum of complete response (CR) plus complete response with incomplete platelet recovery (CRp) plus partial response (PR). Complete response, with platelet incomplete platelet recovery (CRp) is defined as a response that meets CR criteria but platelet count remains below 100 x 10\^9/L. This outcome will be reported as a number. * Complete response (CR) = normalization of white blood cell (WBC) count; absolute eosinophil count in blood; and % eosinophils in blood, without increased blas
Conditions Studied
Interventions
- DRUG Ruxolitinib
Study Locations (4)
California
- Stanford Cancer Institute Palo Alto - Palo Alto
Oregon
- OHSU Knight Cancer Institute - Portland
Utah
- University of Utah - Salt Lake City
Washington
- Fred Hutchinson cancer research center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-11-15 |
| Est. Completion | 2028-12-30 |
| Phase | Phase 2 |
What NCT03801434 shows while recruiting
NCT03801434 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 132-participant average among 7 other Hypereosinophilic Syndrome trials with a reported enrollment target (92% lower).
The record links to 10 conditions, with Hypereosinophilic Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Ruxolitinib is the first listed.
NCT03801434 reports a single indexed study location in California, Oregon, Utah.
Frequently Asked Questions
What is clinical trial NCT03801434 about?
NCT03801434 is a clinical study titled "Ruxolitinib in Treating Patients With Hypereosinophilic Syndrome or Primary Eosinophilic Disorders". This phase II trial studies how well ruxolitinib works in treating patients with hypereosinophilic syndrome or primary eosinophilic disorders.
What is the current status of trial NCT03801434?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2019-11-15. Estimated completion is 2028-12-30.
What conditions does trial NCT03801434 study?
This clinical trial studies the following conditions: Hypereosinophilic Syndrome, Blasts More Than 5 Percent of Bone Marrow Nucleated Cells, Eosinophilia, Chronic Eosinophilic Leukemia, Not Otherwise Specified, BCR-JAK2 Fusion Protein Expression.
What interventions are being tested in trial NCT03801434?
The interventions under investigation include: Ruxolitinib (DRUG).
Who is sponsoring clinical trial NCT03801434?
This trial is sponsored by William Shomali, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03801434 being conducted?
This trial has 4 study locations across California, Oregon, Utah, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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