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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Graft-Versus-Host Disease, GVHD, Undefined

In brief

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.

Key facts

Study ID

NCT05675930

Run by

Memorial Sloan Kettering Cancer Center

People needed

44

Starts

2022-12-22

Expected to finish

2026-12-22

Last updated by the study team

2026-05-22

Who can join

Age: 4 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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