Clinical trial NCT05675930: A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Graft-Versus-Host Disease
GVHD
Undefined
Keywords: Graft-Versus-Host Disease
GVHD
Chronic Graft Versus Host Disease Oral
PhotobiomoduLatIon
Memorial Sloan Kettering Cancer Center
22-271
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 44
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a phase 2, double-blind, randomized (1:1 ratio) study
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Response rate of participants
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute of Health (Data Collection AND Specimen Analysis)
state: Maryland
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge (Consent only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Bergen (Consent only)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Commack (Consent only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (Data Collection Only)
state: Pennsylvania
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Alina Markova, MD
role: PRINCIPAL_INVESTIGATOR
References: