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NCT04908735 · ClinicalTrials.gov registry record · Phase 2
Ruxolitinib for Early Lung Dysfunction After Hematopoietic Stem Cell Transplant
A Phase 2 study of Hematopoietic Stem Cell Transplant (HSCT) and Bronchiolitis Obliterans (BO), sponsored by Children's Hospital Medical Center, Cincinnati.
- Active
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
- 2
- Study locations
NCT04908735 is a Phase 2 study of Hematopoietic Stem Cell Transplant (HSCT) and Bronchiolitis Obliterans (BO) that is active but no longer recruiting, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 7 participants, below the 725-participant average among 3 other Hematopoietic Stem Cell Transplant (HSCT) trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT04908735, a Phase 2 study of Hematopoietic Stem Cell Transplant (HSCT) and Bronchiolitis Obliterans (BO), is active but no longer recruiting, sponsored by Children's Hospital Medical Center, Cincinnati.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
- 2
- Study locations
Study Summary
Hematopoietic stem cell transplant (HSCT) is an effective but toxic therapy, and lung injury affects as many as 25% of children receiving HSCT. Improved transplant techniques and major improvements in survival mean that HSCT is being more widely used, and more mismatched grafts are being used. Bronchiolitis obliterans (BO) is a major limitation of pediatric HSCT success as BO is commonly diagnosed late in children, when lung injury is irreversible, leading to long term morbidity or even death. Currently, there are major gaps in our knowledge regarding incidence, etiology and optimal treatment of BO following HSCT, and important diagnostic limitations specific to children. Diagnosis of BO is usually based on performance of pulmonary function tests, which is usually impossible in ill children under 10. Even older children who feel unwell or un-cooperative may be unable to produce interpretable data. These deficiencies in diagnosis mean that BO is commonly diagnosed late, meaning fibrosis has occurred and lesions are irreversible. The hypothesis for this interventional trial is that early treatment with standard Flovent/montelukast and steroids plus ruxolitinib will reverse lung injury and reduce the frequency of chronic pulmonary impairment or florid BO.
Conditions Studied
Interventions
- DRUG Ruxolitinib
Study Locations (2)
Minnesota
- University of Minnesota - Minneapolis
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2021-11-12 |
| Est. Completion | 2028-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04908735
The ClinicalTrials.gov registry entry for NCT04908735 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 725-participant average among 3 other Hematopoietic Stem Cell Transplant (HSCT) trials with a reported enrollment target (99% lower). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hematopoietic Stem Cell Transplant (HSCT) appearing as the primary indexed condition, and to 1 intervention - of which Ruxolitinib is the first listed.
NCT04908735 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Minnesota, Ohio.
Frequently Asked Questions
What is clinical trial NCT04908735 about?
NCT04908735 is a clinical study titled "Ruxolitinib for Early Lung Dysfunction After Hematopoietic Stem Cell Transplant". Hematopoietic stem cell transplant (HSCT) is an effective but toxic therapy, and lung injury affects as many as 25% of children receiving HSCT. Improved transplant techniques and major improvements in survival mean that HSCT is being more widely used, and more mismatched grafts are being used. Bronc...
What is the current status of trial NCT04908735?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2021-11-12. Estimated completion is 2028-11.
What conditions does trial NCT04908735 study?
This clinical trial studies the following conditions: Hematopoietic Stem Cell Transplant (HSCT), Bronchiolitis Obliterans (BO).
What interventions are being tested in trial NCT04908735?
The interventions under investigation include: Ruxolitinib (DRUG).
Who is sponsoring clinical trial NCT04908735?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04908735 being conducted?
This trial has 2 study locations across Minnesota, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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