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A Study of Belumosudil in Children With Chronic Graft Versus Host Disease (schoolROCK)
NCT07116031 · View on ClinicalTrials.gov ↗
Study Summary
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. 4 weeks of post treatment safety follow-up. Long-term follow-up until death or end of study, whichever occurs first.
Conditions Studied
Interventions
- DRUG Belumosudil
Study Locations (20)
Other
- Investigational Site Number : 0560003 — Ghent
- Investigational Site Number : 0560001 — Leuven
- 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 : 5280001 — Utrecht
New York
- Memorial Sloan Kettering Cancer Center - New York - York Avenue- Site Number : 8400001 — New York
Texas
- Texas Children's Hospital- Site Number : 8400008 — Houston
Ontario
- Investigational Site Number : 1240002 — Toronto
Roma
- Investigational Site Number : 3800001 — Rome
Barcelona [Barcelona]
- Investigational Site Number : 7240003 — Esplugues de Llobregat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2025-12-02 |
| Est. Completion | 2031-02-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07116031
The ClinicalTrials.gov registry entry for NCT07116031 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Chronic Graft Versus Host Disease appearing as the primary indexed condition, and to 1 intervention — of which Belumosudil is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07116031 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Other, New York, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07116031 about?
NCT07116031 is a clinical study titled "A Study of Belumosudil in Children With Chronic Graft Versus Host Disease (schoolROCK)". 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...
What is the current status of trial NCT07116031?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2025-12-02. Estimated completion is 2031-02-28.
What conditions does trial NCT07116031 study?
This clinical trial studies the following conditions: Chronic Graft Versus Host Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07116031?
The interventions under investigation include: Belumosudil (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07116031?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07116031 being conducted?
This trial has 20 study locations across New York, Texas, Ontario, Roma, Barcelona [Barcelona]. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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