A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Graft-Versus-Host Disease, GVHD, Undefined

Intervention / Treatment
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* Device: Photobiomodulation Therapy
* Other: Placebo sham device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a phase 2, double-blind, randomized (1:1 ratio) study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adult and pediatric patients who received an allogeneic stem cell transplant (allo-HCT)<br>Participants are Allo-HCT recipients | Device: Photobiomodulation Therapy<br>* Participants with a history of allo-HCT and diagnosis with oral chronic GvHD randomized to the treatment arm will be treated with oral photobiomodulation/PBM (via Thor LX2.3 system device) for 28 days<br>* Other names: Thor LX2.3 system device;|
| Placebo Comparator: Adult and pediatric patients who received a placebo treatment<br>Participants are Allo-HCT recipients | Other: Placebo sham device<br>* Participants with a history of allo-HCT and diagnosis with oral chronic GvHD randomized to the placebo arm will be treated with a placebo sham device (via Thor LX2.3 sham device setting) for 28 days<br>* Other names: Thor LX2.3 sham device setting;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate of participants | To assess the primary objective, we will compare the treatment response rates, defined as the the proportion of oral GvHD allo-HCT patients who achieve a CR or a PR at Day 28, for the PBM and Placebo arms. The treatment response rate will be calculated within each study arm for all patients who completed at least one PBM or placebo treatment. | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Graft-Versus-Host Disease, GVHD, Chronic Graft Versus Host Disease Oral, PhotobiomoduLatIon, Memorial Sloan Kettering Cancer Center, 22-271