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

Graft-Versus-Host Disease Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05675930
• Other study ID #: 22-271
• Status: Recruiting
• Phase: Phase 2
• Start date: December 22, 2022
• Est. completion date: December 22, 2025

Study information

• Verified date: May 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Alina Markova, MD
• Phone: 6466082342
• Email: markovaa[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 22, 2025
• Est. primary completion date: December 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiolitis Obliterans Syndrome
• Graft vs Host Disease
• Graft-Versus-Host Disease
• GVHD
• Undefined

Intervention

Device:
• Photobiomodulation Therapy
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

Other:
• Placebo sham device
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

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering at Basking Ridge (Consent only)	Basking Ridge	New Jersey
United States	National Institute of Health (Data Collection AND Specimen Analysis)	Bethesda	Maryland
United States	Memorial Sloan Kettering Cancer Center @ Commack (Consent only)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Consent only)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Consent only)	Middletown	New Jersey
United States	Memorial Sloan Kettering Cancer Center @ Bergen (Consent only)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York
United States	University of Pittsburgh Medical Center (Data Collection Only)	Pittsburgh	Pennsylvania
United States	Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center