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Recruiting
NCT05675930
A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant
Conditions: Graft-Versus-Host Disease, GVHD, Undefined
Sex: All
Ages: 4 Years – N/A
Phase: PHASE2
Enrollment: 44
Sponsor: Memorial Sloan Kettering Cancer Center
Location: United States
Summary
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
Inclusion Criteria:Allo-HCT recipientsAge ≥ 4 years-oldOral 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.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.
Source: ClinicalTrials.gov (NCT05675930). StuddyBuddy aggregates publicly available trial information.