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

Description

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.

Conditions

Graft-Versus-Host Disease, GVHD, Undefined

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Graft-Versus-Host Disease
Intervention / Treatment

-

Contacts and Locations

Bethesda

National Institute of Health (Data Collection AND Specimen Analysis), Bethesda, Maryland, United States, 20892

Basking Ridge

Memorial Sloan Kettering at Basking Ridge (Consent only), Basking Ridge, New Jersey, United States, 07920

Middletown

Memorial Sloan Kettering Monmouth (Consent only), Middletown, New Jersey, United States, 07748

Montvale

Memorial Sloan Kettering Cancer Center @ Bergen (Consent only), Montvale, New Jersey, United States, 07645

Commack

Memorial Sloan Kettering Cancer Center @ Commack (Consent only), Commack, New York, United States, 11725

Harrison

Memorial Sloan Kettering Westchester (Consent only), Harrison, New York, United States, 10604

New York

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, United States, 10065

Uniondale

Memorial Sloan Kettering Cancer Center @ Nassau (Consent only), Uniondale, New York, United States, 11553

West Harrison

Memorial Sloan Kettering Westchester (Consent only), West Harrison, New York, United States, 10604

Pittsburg

University of Pittsburgh Medical Center (Data Collection Only), Pittsburg, Pennsylvania, United States, 15213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

4 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Memorial Sloan Kettering Cancer Center,

Alina Markova, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

2025-12-22