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Photobiomodulation Therapy for Oral Graft-Versus-Host Disease

This study is testing if photobiomodulation (PBM) therapy, using the Thor LX2.3 system, is a safe and effective treatment for oral Graft-Versus-Host Disease (GVHD). GVHD is a complication that can happen after a stem cell transplant. You might be able to join if you are at least 4 years old, have had a stem cell transplant, and have oral GVHD that hasn't improved with other treatments like topical corticosteroids. The study will look at how many participants respond to the treatment after 28 days. The current status of this study is unclear.

Study design
This study plans to enroll 44 participants. It is an interventional study where participants will be randomly assigned to receive either photobiomodulation therapy or a placebo sham device.
What's involved
Participants will receive treatment with either the Thor LX2.3 system or a sham device for 28 days.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, which measures the response rate, is assessed at 28 days.

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NCT05675930

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

Recruiting
PHASE2Ages 4+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~44 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Photobiomodulation TherapyPlacebo sham device

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Response rate of participants
Measured over 28 days

Conditions

Graft-Versus-Host Disease
GVHD
Undefined

Explore related trials

Graft Versus Host Disease

Where it's being run

9 sites across 4 states
New York4
New Jersey3
Maryland1
Pennsylvania1

Study leadership

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

Who to contact

Alina Markova, MD
[email protected]
6466082342
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Response rate of participants28 days

    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.