Clinical trial · Interventional
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)
NCT05675930CI-TRIAL-00112457recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Graft-Versus-Host Disease | — | UNRESOLVED | — |
| GVHD | — | UNRESOLVED | — |
| Undefined | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photobiomodulation Therapy | Device | — | UNRESOLVED |
| Placebo sham device | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Adult and pediatric patients who received an allogeneic stem cell transplant (allo-HCT)
- description
- Participants are Allo-HCT recipients
- interventionNames
- Device: Photobiomodulation Therapy
- type
- PLACEBO_COMPARATOR
- label
- Adult and pediatric patients who received a placebo treatment
- description
- Participants are Allo-HCT recipients
- interventionNames
- Other: Placebo sham device
Primary outcomes (1)
- measure
- Response rate of participants
- timeFrame
- 28 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Presence of an active uncontrolled infection. Subjects with a controlled infection receiving definitive therapy for 48 hours prior to enrollment are eligible. * Personal history of mucosal head and neck cancer in the past 5 years. * 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. * Any serious medical or psychiatric illness that could, in the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
References
Publications (0)
Data not yet available
No reference posted for this study.