Graft-Versus-Host DiseasePhase 2NCT05675930
A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant
A Phase 2 study testing Photobiomodulation Therapy in people with Graft-Versus-Host Disease and GVHD, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Graft-Versus-Host Disease, GVHD, Undefined
- What is being tested?
- Photobiomodulation Therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 9 sitesUnited States
- Study dates
- 22 Dec 2022to 22 Dec 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Memorial Sloan Kettering at Basking Ridge (Consent only)
Basking Ridge, New Jersey, 07920
Alina Markova, MD, 646-608-2342
- Recruiting
National Institute of Health (Data Collection AND Specimen Analysis)
Bethesda, Maryland, 20892
Jacqueline Mays, DDS, MHSc, PhD, (301) 496-8800, jacqueline.mays@nih.gov
- Recruiting
Memorial Sloan Kettering Cancer Center @ Commack (Consent only)
Commack, New York, 11725
Alina K Markova, MD, 646-608-2342
- Recruiting
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, 10604
Alina Markova, MD, 646-608-2342
- Recruiting
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, 07748
Alina Markova, MD, 646-608-2342
- Recruiting
Memorial Sloan Kettering Cancer Center @ Bergen (Consent only)
Montvale, New Jersey, 07645
Alina K Markova, MD, 646-608-2342
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Alina Markova, MD, 646-608-2342
- Recruiting
University of Pittsburgh Medical Center (Data Collection Only)
Pittsburgh, Pennsylvania, 15213
Annie Im, MD, 412-864-7764, imap@upmc.edu
- Recruiting
Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)
Uniondale, New York, 11553
Alina K Markova, MD, PhD, 646-608-2342
About this study
Official title: 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.
- Conditions
- Graft-Versus-Host Disease, GVHD, Undefined
- Being tested
- Photobiomodulation Therapy, Placebo sham device
- Keywords
- Graft-Versus-Host Disease, GVHD, Chronic Graft Versus Host Disease Oral, PhotobiomoduLatIon, Memorial Sloan Kettering Cancer Center, 22-271
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation TherapyDevice
Also called PBM Therapy, Thor LX2.3 system device
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
Placebo sham deviceOther
Also called Thor LX2.3 sham device setting
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
| Study group | Role | What they receive |
|---|---|---|
| Adult and pediatric patients who received an allogeneic stem cell transplant (allo-HCT) | Active comparator | Participants are Allo-HCT recipients Receives: Device: Photobiomodulation Therapy |
| Adult and pediatric patients who received a placebo treatment | Placebo comparator | Participants are Allo-HCT recipients Receives: Other: Placebo sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start22 Dec 2022
- Primary completion22 Dec 2026 (estimated)
- Study completion22 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft-Versus-Host DiseaseStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a phase 2, double-blind, randomized (1:1 ratio) study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alina Markova, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675930
- Sponsor's protocol ID
- 22-271
- Status last verified
- May 2026
- First submitted
- 22 Dec 2022
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: • 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.