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NCT05675930PHASE2Recruiting

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

Memorial Sloan Kettering Cancer Center

Start Date

12/22/2022

Completion Date

12/22/2026

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.

Eligibility Criteria

Age Range: 4 years to No maximum

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.

Interventions

DEVICE

Photobiomodulation Therapy

OTHER

Placebo sham device

Interested in This Trial?

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Conditions

Graft-Versus-Host DiseaseGVHDUndefined

Locations

National Institute of Health (Data Collection AND Specimen Analysis)

Bethesda, Maryland 20892

United States

Memorial Sloan Kettering at Basking Ridge (Consent only)

Basking Ridge, New Jersey 07920

United States

Memorial Sloan Kettering Monmouth (Consent only)

Middletown, New Jersey 07748

United States

Memorial Sloan Kettering Cancer Center @ Bergen (Consent only)

Montvale, New Jersey 07645

United States

Memorial Sloan Kettering Cancer Center @ Commack (Consent only)

Commack, New York 11725

United States

Memorial Sloan Kettering Westchester (Consent only)

Harrison, New York 10604

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York 10065

United States

Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)

Uniondale, New York 11553

United States

University of Pittsburgh Medical Center (Data Collection Only)

Pittsburgh, Pennsylvania 15213

United States