Actively Recruiting
A Multi-Center Phase II Randomized Double-Blind Trial to Evaluate Photobiomodulation for Oral Chronic Graft-Versus-Host Disease After Allogeneic Stem Cell Transplantation
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-22
44
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating photobiomodulation (PBM) therapy using the Thor LX2.3 device to determine its safety and effectiveness for treating oral chronic Graft-Versus-Host Disease (GVHD) in patients who have received allogeneic stem cell transplants (allo-HCT). This Phase II trial is randomized and double-blind, aiming to compare PBM therapy against a placebo sham device in both adult and pediatric participants with oral GVHD. Participants diagnosed with oral chronic GVHD who have previously undergone allo-HCT are randomly assigned to receive either the active PBM treatment or a placebo sham device. The treatment is administered daily for 28 days using the Thor LX2.3 therapy system or the sham device, respectively. The study monitors response rates 28 days after treatment to assess efficacy and safety. During the trial, participants will be monitored for their response to the therapy, including assessments of oral symptoms using standardized scoring. Stable use of other oral topical treatments is allowed if maintained for at least two weeks prior to enrollment. Researchers will collect data on the response rate at 28 days post-treatment. Safety is closely observed, and participants must comply with follow-up visits, supportive care, and research tests throughout the study period.
CONDITIONS
Brief Title
A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Received an allogeneic stem cell transplant (allo-HCT)
- Age 4 years or older
- Oral chronic GVHD with NIH-modified Oral Mucosal Rating Scale score of 3 or higher
- Have failed at least one prior line of therapy including topical corticosteroids
- No change in systemic immunosuppressive therapy type or intensity within 2 weeks before enrollment
- Stable on any oral topical treatment for mouth symptoms for at least 2 weeks before enrollment and able to continue during study
You will not qualify if you...
- Have an active uncontrolled infection
- History of mucosal head and neck cancer within the past 5 years
- Pregnant or breastfeeding
- Unable to give informed consent or comply with study protocol and follow-up
- Have serious medical or psychiatric illness that may interfere with treatment completion
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants with oral chronic GVHD after allogeneic stem cell transplant receive either photobiomodulation therapy or a placebo sham device treatment.
Daily visits or treatments for 28 days
Trial Site Locations
Total: 9 locations
1
National Institute of Health (Data Collection AND Specimen Analysis)
Bethesda, Maryland, United States, 20892
Actively Recruiting
2
Memorial Sloan Kettering at Basking Ridge (Consent only)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
3
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, United States, 07748
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center @ Bergen (Consent only)
Montvale, New Jersey, United States, 07645
Actively Recruiting
5
Memorial Sloan Kettering Cancer Center @ Commack (Consent only)
Commack, New York, United States, 11725
Actively Recruiting
6
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, United States, 10604
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
8
Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)
Uniondale, New York, United States, 11553
Actively Recruiting
9
University of Pittsburgh Medical Center (Data Collection Only)
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
A
Alina Markova, MD
D
Doris Ponce, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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