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

Phase 2

Recruiting

• Conditions: Graft-Versus-Host Disease; Undefined; GVHD
• Interventions: Device: Photobiomodulation Therapy; Other: Placebo sham device

• Registration Number: NCT05675930
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-22
• Study First Submitted: 2022-12-22
• Study First Submitted QC: 2022-12-22
• Study First Posted: 2023-01-09
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-13
• Primary Completion: 2026-12-22
• Study Completion: 2026-12-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adult and pediatric patients who received an allogeneic stem cell transplant (allo-HCT)	Photobiomodulation Therapy	Participants are Allo-HCT recipients
Adult and pediatric patients who received a placebo treatment	Placebo sham device	Participants are Allo-HCT recipients

Primary Outcome Measures

Name	Time	Method
Response rate of participants	28 days	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.

Trial Locations

Locations (9)

National Institute of Health (Data Collection AND Specimen Analysis); 🇺🇸 Bethesda, Maryland, United States

Memorial Sloan Kettering at Basking Ridge (Consent only); 🇺🇸 Basking Ridge, New Jersey, 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 @ Commack (Consent only); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester (Consent only); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Cancer Center @ Nassau (Consent only); 🇺🇸 Uniondale, New York, United States

University of Pittsburgh Medical Center (Data Collection Only); 🇺🇸 Pittsburgh, Pennsylvania, United States