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

Last updated: May 7, 2025
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting

Phase

2

Condition

Transplant Rejection

Treatment

Placebo sham device

Photobiomodulation Therapy

Clinical Study ID

NCT05675930
22-271
  • Ages > 4
  • All Genders

Study 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

Inclusion

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 2weeks prior to enrollment.

  • If a patient is currently using another oral topical treatment for mouthlesions/symptoms, patient must be stable on this treatment for ≥2 weeks prior tostudy enrollment. Patient may continue same topical dose/frequency during the studyperiod.

Exclusion

Exclusion Criteria:

  • Presence of an active uncontrolled infection. Subjects with a controlled infectionreceiving 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 withthe treatment protocol including appropriate supportive care, follow-up, andresearch tests.

  • Any serious medical or psychiatric illness that could, in the Investigator'sopinion, potentially interfere with the completion of treatment according to thisprotocol.

Study Design

Total Participants: 44
Treatment Group(s): 2
Primary Treatment: Placebo sham device
Phase: 2
Study Start date:
December 22, 2022
Estimated Completion Date:
December 22, 2026

Connect with a study center

  • National Institute of Health (Data Collection AND Specimen Analysis)

    Bethesda, Maryland 20892
    United States

    Active - Recruiting

  • Memorial Sloan Kettering at Basking Ridge (Consent only)

    Basking Ridge, New Jersey 07920
    United States

    Active - Recruiting

  • Memoral Sloan Kettering Monmouth (Consent only)

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Monmouth (Consent only)

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center @ Bergen (Consent only)

    Montvale, New Jersey 07645
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center @ Commack (Consent only)

    Commack, New York 11725
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Westchester (Consent only)

    Harrison, New York 10604
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York 10065
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)

    Uniondale, New York 11553
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Westchester (Consent only)

    West Harrison, New York 10604
    United States

    Site Not Available

  • University of Pittsburgh Medical Center (Data Collection Only)

    Pittsburg, Pennsylvania 15213
    United States

    Site Not Available

  • University of Pittsburgh Medical Center (Data Collection Only)

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

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