Actively Recruiting
A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-30
44
Participants Needed
9
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 allogeneic hematopoietic cell transplantation (allo-HCT)
- Age 4 years or older
- Oral chronic GvHD with NIH-modified Oral Mucosal Rating Scale score of 3 or higher
- Failed at least one line of therapy including topical corticosteroids
- Stable systemic immunosuppressive therapy with no changes in type or intensity within 2 weeks prior to enrollment
- Stable use of any oral topical treatment for mouth lesions for at least 2 weeks prior to enrollment, with the same dose and frequency continued during the study
You will not qualify if you...
- Active uncontrolled infection (patients with controlled infection on therapy for at least 48 hours prior to enrollment are eligible)
- Personal 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
- Any serious medical or psychiatric illness that could interfere with treatment completion according to the study protocol
AI-Screening
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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
CONTACT
D
Doris Ponce, MD
CONTACT
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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