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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age4+
SponsorMemorial Sloan Kettering Cancer Center

About this 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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Photobiomodulation Therapy
  • Placebo sham device

Treatment groups

44 Participants
are divided into 2 treatment groups

Locations

9
National Institute of Health (Data Collection AND Specimen Analysis)20892, BethesdaMaryland, United States
Memorial Sloan Kettering at Basking Ridge (Consent only)07920, Basking RidgeNew Jersey, United States
Memorial Sloan Kettering Monmouth (Consent only)07748, MiddletownNew Jersey, United States
Memorial Sloan Kettering Cancer Center @ Bergen (Consent only)07645, MontvaleNew Jersey, United States

Sponsors and collaborators

Memorial Sloan Kettering Cancer Center

Lead sponsor