A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease.
Condition(s) studied
Investigational drug(s) / intervention(s)
Belumosudil: Pharmaceutical form:Tablet-Route of administration:oral
Placebo: Pharmaceutical form:Table-Route of administration:oral
Prednisone: Pharmaceutical form:Tablet-Route of administration:oral
Prednisolone: Pharmaceutical form:Tablet-Route of administration:oral
Study summary
This is a parallel, Phase 3, two-arm study for the treatment of newly diagnosed moderate or severe chronic GVHD.
The study duration for a participant includes up to 4 weeks for screening; a treatment period until clinically meaningful cGVHD progression (defined as progression requiring addition of new systemic treatment for cGVHD), relapse/recurrence of the underlying disease, participant starts new systemic treatment for cGVHD or experiences an unacceptable toxicity, at the request of the participants or the investigators, or until the end of study is reached, whichever comes first; at least 30 days follow-up of adverse events (AEs) after the last dose until resolution or stabilization, if applicable; and long-term follow-up until death or study close-out, whichever comes first.
Eligibility
Primary outcome measure(s)
- Event-Free Survival (EFS) — Until the end of the study (up to 2.5 years since first patient in).
From the date of randomization to the date of any predefined event, whichever occurs first
Trial sites (151)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Arkansas for Medical Sciences-Site Number : 8400019 | Little Rock | Arkansas | |
| City of Hope National Medical Center- Site Number : 8400001 | Duarte | California | |
| University of California San Francisco - Parnassus Heights- Site Number : 8400035 | San Francisco | California | |
| AdventHealth Orlando- Site Number : 8400023 | Orlando | Florida | |
| The Hope Clinic of Emory University- Site Number : 8400020 | Decatur | Georgia | |
| Northwestern University- Site Number : 8400017 | Chicago | Illinois | |
| Indiana University Health University Hospital- Site Number : 8400006 | Indianapolis | Indiana | |
| University of Kentucky Chandler Medical Center- Site Number : 8400024 | Lexington | Kentucky | |
| Johns Hopkins Hospital- Site Number : 8400033 | Baltimore | Maryland | |
| Dana Farber Cancer Institute Site Number : 8400005 | Boston | Massachusetts | |
| Karmanos Cancer Institute - Detroit- Site Number : 8400013 | Detroit | Michigan | |
| UNC Children's Hospital- Site Number : 8400025 | Chapel Hill | North Carolina | |
| Atrium Health Wake Forest Baptist Medical Center - Winston-Salem - Medical Center Boulevard- Site Number : 8400007 | Winston-Salem | North Carolina | |
| Oncology Hematology Care - Kenwood- Site Number : 8400030 | Cincinnati | Ohio | |
| The Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute- Site Number : 8400026 | Columbus | Ohio | |
| Oregon Health and Science University- Site Number : 8400027 | Portland | Oregon | |
| UPMC Hillman Cancer Center- Site Number : 8400008 | Pittsburgh | Pennsylvania | |
| Sarah Cannon Research Institute Site Number : 8400003 | Nashville | Tennessee | |
| St. David's South Austin Medical Center- Site Number : 8400002 | Austin | Texas | |
| Texas Oncology - Dallas - Worth Street- Site Number : 8400010 | Dallas | Texas | |
| Texas Transplant Institute - Methodist Hospital- Site Number : 8400037 | San Antonio | Texas | |
| University of Virginia Comprehensive Cancer Center-Site Number : 8400031 | Charlottesville | Virginia | |
| Fred Hutchinson Cancer Research Center- Site Number : 8400004 | Seattle | Washington | |
| University of Wisconsin Carbone Cancer Center-Site Number : 8400029 | Madison | Wisconsin | |
| Investigational Site Number : 0320006 | Pilar | Buenos Aires | |
| Investigational Site Number : 0320005 | Buenos Aires | Argentina | |
| Investigational Site Number : 0320003 | Buenos Aires | Argentina | |
| Investigational Site Number : 0320001 | Buenos Aires | Argentina | |
| Investigational Site Number : 0320002 | Buenos Aires | Argentina | |
| Investigational Site Number : 0320004 | Córdoba | Argentina | |
| Investigational Site Number : 0360005 | Westmead | New South Wales | |
| Investigational Site Number : 0360003 | Brisbane | Queensland | |
| Investigational Site Number : 0360001 | Melbourne | Victoria | |
| Investigational Site Number : 0360004 | Murdoch | Western Australia | |
| Investigational Site Number : 0400003 | Graz | Austria | |
| Investigational Site Number : 0400001 | Linz | Austria | |
| Investigational Site Number : 0400004 | Vienna | Austria | |
| Cliniques Universitaires St. Luc-Investigational Site Number : 0560005 | Woluwe | Brussels Capital | |
| UZ Leuven-Investigational Site Number : 0560001 | Leuven | Vlaams-Brabant | |
| Investigational Site Number : 0560006 | Bruges | Belgium |
+ 111 more sites — see the full list on the official registry below.
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06143891 on ClinicalTrials.gov ↗ ← All trials in the UK