NCT05675930RecruitingPhase 2
A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant
A Multi-Center, Phase II, Randomized Double-Blind Trial to Evaluate the Efficacy and Safety of Photobiomodulation for the Treatment of Oral Chronic Graft-Versus-Host Disease After Allogeneic Stem Cell Transplantation (the LIGHT Trial)
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
The purpose of this study is to find out whether photobiomodulation/PBM therapy using the Thor LX2.3 therapy system is a safe and effective treatment for oral Graft-Versus-Host Disease/GVHD.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- First submitted
- 22 Dec 2022
- Start date
- 22 Dec 2022
- Primary completion date
- 22 Dec 2026
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Childhood cancers
- NCT number
- NCT05675930
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 44
- From 22 Dec 2022 to the primary completion date, 22 Dec 2026
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of an active uncontrolled infection. Subjects with a controlled infection receiving definitive therapy for 48 hours prior to enrollment are eligible.
Other illness
- Personal history of mucosal head and neck cancer in the past 5 years.
- Any serious medical or psychiatric illness that could, in the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
Other
- Pregnant or breastfeeding.
- The subject or guardian is unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up, and research tests.
Who the study is looking for
- Allo-HCT recipients
- Age ≥ 4 years-old
- Oral cGvHD with NIH-modified OMRS score ≥ 3 who have failed ≥ 1 line of therapy, including topical corticosteroids..
- No change in systemic immunosuppressive therapy (type or intensity level) within 2 weeks prior to enrollment.
- If a patient is currently using another oral topical treatment for mouth lesions/symptoms, patient must be stable on this treatment for ≥2 weeks prior to study enrollment. Patient may continue same topical dose/frequency during the study period.
Age in the registry: 4 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge (Consent Only) Coordinator of this site? Confirm its status | Basking Ridge | United States | Recruiting |
| National Institute of Health (Data Collection AND Specimen Analysis) Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center @ Commack (Consent Only) Coordinator of this site? Confirm its status | Commack | United States | Recruiting |
| Memorial Sloan Kettering Westchester (Consent only) Coordinator of this site? Confirm its status | Harrison | United States | Recruiting |
| Memorial Sloan Kettering Monmouth (Consent Only) Coordinator of this site? Confirm its status | Middletown | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center @ Bergen (Consent only) Coordinator of this site? Confirm its status | Montvale | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| University of Pittsburgh Medical Center (Data Collection Only) Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center @ Nassau (Consent only) Coordinator of this site? Confirm its status | Uniondale | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.