A Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH-1)
Part of paid clinical trials in Tucson, Arizona.
- Sponsor
- Incyte Corporation
- Study ID
- NCT02953678
- Phase
- PHASE2
- Status
- Completed
Conditions
- Graft-versus-host Disease (GVHD)
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ruxolitinib — DRUG
- Prednisone or methylprednisolone — DRUGEither oral prednisone or IV methylprednisolone may be used to begin corticosteroid treatment at the investigator's discretion.
Study Details
The purpose of this study was to assess the efficacy of ruxolitinib in combination with corticosteroids in subjects with Grades II to IV steroid-refractory acute graft-versus-host disease (GVHD).
Key Dates
- Start date
- Dec 30, 2016
- Status verified
- Oct 2021
- Primary completion
- Jan 31, 2018
- Completion
- Aug 14, 2019
Study Design
- Enrollment
- 71 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Ruxolitinib in combination with corticosteroidsParticipants began oral administration of ruxolitinib at 5 mg twice daily (BID); if stable after the first 3 days of treatment, the dose could be increased to 10 mg BID.
Primary Outcome Measure
Overall Response Rate (ORR) at Day 28 [ Time Frame: From baseline to Day 28 ]
Locations (38)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| - | Tucson | Arizona | 85719 | - |
| - | Duarte | California | 31010 | - |
| - | La Jolla | California | 92903 | - |
| - | Los Angeles | California | 90033 | - |
| - | Los Angeles | California | 90095 | - |
| - | Stanford | California | 94306 | - |
| - | Denver | Colorado | 80218 | - |
| - | Gainesville | Florida | 32610 | - |
| - | Miami | Florida | 33136 | - |
| - | Tampa | Florida | 33612 | - |
| - | Atlanta | Georgia | 30322 | - |
| - | Chicago | Illinois | 60611 | - |
| - | Chicago | Illinois | 60637 | - |
| - | Lexington | Kentucky | 40536-0293 | - |
| - | Boston | Massachusetts | 02114 | - |
| - | Grand Rapids | Michigan | 49503 | - |
| - | Minneapolis | Minnesota | 55455 | - |
| - | St Louis | Missouri | 63110 | - |
| - | Hackensack | New Jersey | 07601 | - |
| - | New York | New York | 10022 | - |
| - | New York | New York | 10065 | - |
| - | Rochester | New York | 14642 | - |
| - | Charlotte | North Carolina | 28204 | - |
| - | Cincinnati | Ohio | 45242 | - |
| - | Cleveland | Ohio | 44195 | - |
| - | Philadelphia | Pennsylvania | 19104 | - |
| - | Philadelphia | Pennsylvania | 19107 | - |
| - | Pittsburgh | Pennsylvania | 15224 | - |
| - | Pittsburgh | Pennsylvania | 15232 | - |
| - | Nashville | Tennessee | 37203 | - |
| - | Nashville | Tennessee | 37232 | - |
| - | Dallas | Texas | 75246 | - |
| - | San Antonio | Texas | 78229 | - |
| - | Salt Lake City | Utah | 84112 | - |
| - | Seattle | Washington | 98109 | - |
| - | Morgantown | West Virginia | 26506 | - |
| - | Madison | Wisconsin | 53705 | - |
| - | Milwaukee | Wisconsin | 53226 | - |
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