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

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Dec 22, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called photobiomodulation (PBM) therapy for people with oral Graft-Versus-Host Disease (GVHD) after they have received a stem cell transplant. GVHD is a condition where the transplanted cells attack the body's own tissues, and in this case, it affects the mouth. The goal of the study is to determine if this PBM therapy, which uses a special light system called Thor LX2.3, is safe and effective for treating the oral symptoms of GVHD.

To participate in the trial, you need to be at least 4 years old and have been diagnosed with oral GVHD that has not responded to previous treatments, including topical corticosteroids. You should not have changed your other medications in the two weeks before joining the trial. If you are currently using any other treatments for mouth sores, you need to have been stable on them for at least two weeks. Participants can expect regular visits to receive the PBM therapy and to monitor their progress throughout the study. It’s important to note that certain conditions, like active infections or serious health issues, may prevent someone from being eligible for the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.