A Study of Belumosudil in Children With Chronic Graft Versus Host Disease (schoolROCK) (NCT07116031)
An Open-label, Phase 1/2, Multicenter Study of Belumosudil in Children Aged 1 to <18 Years Requiring Systemic Treatment for Active Moderate-to-severe Chronic Graft Versus Host Disease (cGVHD)
🩺 Plain-English Summary (8th-Grade Level)
This is an open-label, single group, Phase 1/2, 1-arm study for treatment of children aged 1 to \<18 years with active moderate-to-severe cGVHD that is refractory to or recurred after at least 2 prior lines of systemic therapy for cGVHD. The purpose of Phase 1 is to determine the PK profiles and to establish the Recommended Pediatric Equivalent Dose (RPED) of belumosudil in participants aged 1 to \<12 years with active moderate to severe cGVHD. Upon completion and evaluation of Phase 1, Phase 2 will commence with the purpose of determining safety and efficacy (ORR by 24 weeks) of belumosudil in participants aged 1 to \<18 years. Study details include: The end of study is defined as 3 years after the last participant is recruited or all participants have discontinued treatment, or have died, whichever comes first. Minimum of 6 participants ages 1 to 6 years will be enrolled for each phase of study Individual participant duration on study will consist of: Up to 4 weeks for screening. Treatment until clinically significant progression of cGVHD, relapse/recurrence of the underlying disease, start of a new systemic treatment for cGVHD, experience of an unacceptable adverse event, request from participant or Investigator, or until the end of the study is reached, whichever comes first. 30 days of post treatment safety follow-up. Long-term follow-up until death or end of study, whichever occurs first.
Who can join: Review the eligibility criteria below.
Location: Children's Hospital Los Angeles- Site Number : 8400009 — Los Angeles, California
Age range: 1 Year to 18 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 (33 Sites)
Showing the first 25 of 33 sites.
- Children's Hospital Los Angeles- Site Number : 8400009 — Los Angeles, California
- Children's National Medical Center - Washington- Site Number : 8400005 — Washington D.C., District of Columbia
- Memorial Sloan Kettering Cancer Center - New York - York Avenue- Site Number : 8400001 — New York, New York
- Texas Children's Hospital- Site Number : 8400008 — Houston, Texas
- Fred Hutchinson Cancer Research Center- Site Number : 8400002 — Seattle, Washington
- Investigational Site Number : 0560003 — Ghent,
- Investigational Site Number : 0560001 — Leuven,
- Investigational Site Number : 1240001 — Vancouver, British Columbia
- Investigational Site Number : 1240002 — Toronto, Ontario
- Investigational Site Number : 1560003 — Beijing,
- Investigational Site Number : 1560001 — Shanghai,
- Investigational Site Number : 1560004 — Shenzhen,
- Investigational Site Number : 1560002 — Suzhou,
- Investigational Site Number : 2500002 — Marseille,
- Investigational Site Number : 2500001 — Paris,
- Investigational Site Number : 2760001 — Berlin,
- Investigational Site Number : 3760005 — Haifa,
- Investigational Site Number : 3760002 — Jerusalem,
- Investigational Site Number : 3760004 — Petah Tikva,
- Investigational Site Number : 3760003 — Ramat Gan,
- Investigational Site Number : 3760001 — Tel Aviv,
- Investigational Site Number : 3800002 — Milan, Milano
- Investigational Site Number : 3800001 — Rome, Roma
- Investigational Site Number : 3800003 — Turin, Torino
- Investigational Site Number : 3920002 — Tokyo,
📞 Contact the Study Coordinator
Phone: (800) 633-1610
Email: contact-us@sanofi.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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
- 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. — Little Rock, Arkansas
- 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.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.