Study of Ruxolitinib in Sclerotic Chronic Graft-Versus-Host Disease After Failure of Systemic Glucocorticoids
Part of paid clinical trials in Tampa, Florida.
- Sponsor
- University of Nebraska
- Study ID
- NCT03616184
- Phase
- PHASE2
- Status
- Completed
Conditions
- Graft-versus-host-disease (GVHD)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ruxolitinib — DRUGPatients with sclerotic chronic graft-versus-host disease (GVHD) will receive oral ruxolitinib at a dose of 10 mg twice daily. Doses may not exceed 10 mg twice daily. Ruxolitinib will be continued for 6 months. Patients who continue to have stable disease, mixed responses or partial/complete responses at the end of 6 months may continue the drug for a total of 12 months.
Study Details
The primary objective of the study is to examine the efficacy of ruxolitinib in patients with sclerotic chronic graft-versus-host disease (GVHD).
Key Dates
- Start date
- Sep 5, 2018
- Status verified
- Sep 2023
- Primary completion
- Jan 22, 2022
- Completion
- Jun 12, 2023
Study Design
- Enrollment
- 49 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: RuxolitinibPatients will receive oral ruxolitinib at a dose of 10 mg twice daily.
Primary Outcome Measure
Percentage of Participants With Complete and Partial Responses in Skin and/or Joint [ Time Frame: 6 months ]
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | - |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | - |
| Cleveland Clinic | Cleveland | Ohio | 44195 | - |
| Ohio State University | Columbus | Ohio | 43210 | - |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | - |