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RecruitingInterventionalPhase 2

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)

NCT ID: NCT05675930Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2026-05-22

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.

Arms & interventions

  • DevicePhotobiomodulation 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

  • OtherPlacebo 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

Outcome measures

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.

    Time frame: 28 days

Eligibility criteria

Sex: AllAge: 4 Years and olderHealthy volunteers: No
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 locations (9)

National Institute of Health (Data Collection AND Specimen Analysis)

Bethesda, Maryland, 20892

Recruiting
Jacqueline Mays, DDS, MHSc, PhD · Contact

Memorial Sloan Kettering at Basking Ridge (Consent only)

Basking Ridge, New Jersey, 07920

Recruiting
Alina Markova, MD · Contact

Memorial Sloan Kettering Monmouth (Consent only)

Middletown, New Jersey, 07748

Recruiting
Alina Markova, MD · Contact

Memorial Sloan Kettering Cancer Center @ Bergen (Consent only)

Montvale, New Jersey, 07645

Recruiting
Alina K Markova, MD · Contact

Memorial Sloan Kettering Cancer Center @ Commack (Consent only)

Commack, New York, 11725

Recruiting
Alina K Markova, MD · Contact

Memorial Sloan Kettering Westchester (Consent only)

Harrison, New York, 10604

Recruiting
Alina Markova, MD · Contact

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

Recruiting
Alina Markova, MD · Contact

Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)

Uniondale, New York, 11553

Recruiting
Alina K Markova, MD, PhD · Contact

University of Pittsburgh Medical Center (Data Collection Only)

Pittsburgh, Pennsylvania, 15213

Recruiting
Annie Im, MD · Contact