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. (NCT06143891)
A Randomized, Double-blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of Belumosudil in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease (cGVHD)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Arkansas for Medical Sciences-Site Number : 8400019 — Little Rock, Arkansas
Age range: 12 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (151 Sites)
Showing the first 25 of 151 sites.
- 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
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Chronic Graft Versus Host Disease
- Predicting the Quality of Response to Specific Treatments in Patients With cGVHD, PQRST Study — Gainesville, Florida
- Leflunomide in Treating Patients With Steroid Dependent Chronic Graft Versus Host Disease — Duarte, California
- Trial of Regulatory T-cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic Graft-versus-Host-Disease — Boston, Massachusetts
- Improving Outcomes Assessment in Chronic GVHD — Stanford, California
- Mindfulness Intervention to Reduce Patient Reported Symptoms in Patients With Chronic Graft-Versus-Host Disease — Duarte, California
Explore by condition: All Chronic Graft Versus Host Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.