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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Graft-Versus-Host Disease; GVHD; Undefined
• Intervention / Treatment: Device: Photobiomodulation Therapy; Other: Placebo sham device

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Alina Markova, MD; Phone Number: 6466082342; Email: markovaa@mskcc.org
• Study Contact Backup: Name: Doris Ponce, MD; Phone Number: 646-608-3739; Email: ponced@mskcc.org

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institute of Health (Data Collection AND Specimen Analysis)
      • Contact: Jacqueline Mays, DDS, MHSc, PhD; Phone Number: (301) 496-8800; Email: jacqueline.mays@nih.gov
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Memorial Sloan Kettering at Basking Ridge (Consent Only)
      • Contact: Alina Markova, MD; Phone Number: 646-608-2342
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth (Consent Only)
      • Contact: Alina Markova, MD; Phone Number: 646-608-2342
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Cancer Center @ Bergen (Consent only)
      • Contact: Alina K Markova, MD; Phone Number: 646-608-2342
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Cancer Center @ Commack (Consent only)
      • Contact: Alina K Markova, MD; Phone Number: 646-608-2342
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester (Consent only)
      • Contact: Alina Markova, MD; Phone Number: 646-608-2342
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
      • Contact: Alina Markova, MD; Phone Number: 646-608-2342
    • Uniondale, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)
      • Contact: Alina K Markova, MD, PhD; Phone Number: 646-608-2342
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh Medical Center (Data Collection Only)
      • Contact: Annie Im, MD; Phone Number: 412-864-7764; Email: imap@upmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Adult and pediatric patients who received an allogeneic stem cell transplant (allo-HCT); Participants are Allo-HCT recipients	Device: Photobiomodulation 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; Other Names: PBM Therapy; Thor LX2.3 system device
Placebo Comparator: Adult and pediatric patients who received a placebo treatment; Participants are Allo-HCT recipients	Other: Placebo 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; Other Names: Thor LX2.3 sham device setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 days

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Alina Markova, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2022
• Primary Completion (Estimated): December 22, 2026
• Study Completion (Estimated): December 22, 2026

Study Registration Dates

• First Submitted: December 22, 2022
• First Submitted That Met QC Criteria: December 22, 2022
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Memorial Sloan Kettering Cancer Center; Graft-Versus-Host Disease; GVHD; Chronic Graft Versus Host Disease Oral; PhotobiomoduLatIon; 22-271
• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease; Therapeutics; Laser Therapy; Phototherapy; Low-Level Light Therapy
• Other Study ID Numbers: 22-271

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: • Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No