Using light therapy to treat oral Graft-Versus-Host Disease after stem cell transplant
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)
This study tests if a special light therapy can help people with oral Graft-Versus-Host Disease after a stem cell transplant feel better when other treatments haven't worked.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 4 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 9 sites (Bethesda, Maryland and 8 other locations) |
| Trial ID | NCT05675930 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and effectiveness of photobiomodulation (PBM) therapy for patients suffering from oral Graft-Versus-Host Disease (GVHD) following stem cell transplantation. Participants will receive either the PBM therapy using the Thor LX2.3 system or a placebo sham device. Eligible patients are those who have experienced oral cGVHD and have not responded to at least one prior treatment. The study aims to provide a new therapeutic option for this challenging condition.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 4 years and older who have oral cGVHD with a specific severity score and have failed previous treatments.
Not a fit: Patients with active uncontrolled infections or those with a history of mucosal head and neck cancer in the past five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could offer a non-invasive treatment option for patients with oral GVHD, potentially improving their quality of life.
How similar studies have performed: While this approach is relatively novel, similar studies using light therapy for other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bethesda, Maryland and 8 other locations
- National Institute of Health (Data Collection AND Specimen Analysis) — Bethesda, Maryland, United States (Recruiting)
- Memorial Sloan Kettering at Basking Ridge (Consent only) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Consent only) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center @ Bergen (Consent only) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center @ Commack (Consent only) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Consent only) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center @ Nassau (Consent only) — Uniondale, New York, United States (Recruiting)
- University of Pittsburgh Medical Center (Data Collection Only) — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Alina Markova, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Alina Markova, MD
- Email: markovaa@mskcc.org
- Phone: 6466082342
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.