A Multi-Center, Phase II, Randomized Double-Blind Trial to Evaluate the Efficacy and Safety of Photobiomodulation for the Treatment of Oral Chronic Graft-Versus-Host Disease After Allogeneic Stem Cell Transplantation (the LIGHT Trial)
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 4
Healthy Volunteers: f
View:
• 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.
Locations
United States
Maryland
National Institute of Health (Data Collection AND Specimen Analysis)
RECRUITING
Bethesda
New Jersey
Memorial Sloan Kettering at Basking Ridge (Consent only)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (Consent only)
RECRUITING
Middletown
Memorial Sloan Kettering Cancer Center @ Bergen (Consent only)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Cancer Center @ Commack (Consent only)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (Consent only)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITING
New York
Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)
RECRUITING
Uniondale
Pennsylvania
University of Pittsburgh Medical Center (Data Collection Only)
RECRUITING
Pittsburgh
Contact Information
Primary
Alina Markova, MD
markovaa@mskcc.org
6466082342
Backup
Doris Ponce, MD
ponced@mskcc.org
646-608-3739
Time Frame
Start Date: 2022-12-22
Estimated Completion Date: 2026-12-22
Participants
Target number of participants: 44
Treatments
Active_comparator: Adult and pediatric patients who received an allogeneic stem cell transplant (allo-HCT)
Participants are Allo-HCT recipients
Placebo_comparator: Adult and pediatric patients who received a placebo treatment
Participants are Allo-HCT recipients
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center