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