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

Purpose

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.

Conditions

  • Graft-Versus-Host Disease
  • GVHD
  • Undefined

Eligibility

Eligible Ages
Over 4 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is a phase 2, double-blind, randomized (1:1 ratio) study
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)
Masking Description
Double-blind

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Adult and pediatric patients who received an allogeneic stem cell transplant (allo-HCT) 		Participants are Allo-HCT recipients
  • Device: Photobiomodulation Therapy
    Participants with a history of allo-HCT and diagnosis with oral chronic GvHD randomized to the treatment arm will be treated with oral photobiomodulation/PBM (via Thor LX2.3 system device) for 28 days
    Other names:
    • PBM Therapy
    • Thor LX2.3 system device
Placebo Comparator
Adult and pediatric patients who received a placebo treatment 		Participants are Allo-HCT recipients
  • Other: Placebo sham device
    Participants with a history of allo-HCT and diagnosis with oral chronic GvHD randomized to the placebo arm will be treated with a placebo sham device (via Thor LX2.3 sham device setting) for 28 days
    Other names:
    • Thor LX2.3 sham device setting

Recruiting Locations

National Institute of Health (Data Collection AND Specimen Analysis)
Bethesda 4348599, Maryland 4361885 20892
Contact:
Jacqueline Mays, DDS, MHSc, PhD
(301) 496-8800
jacqueline.mays@nih.gov

Memorial Sloan Kettering at Basking Ridge (Consent only)
Basking Ridge 5095409, New Jersey 5101760 07920
Contact:
Alina Markova, MD
646-608-2342

Memorial Sloan Kettering Monmouth (Consent only)
Middletown 5101170, New Jersey 5101760 07748
Contact:
Alina Markova, MD
646-608-2342

Memorial Sloan Kettering Cancer Center @ Bergen (Consent only)
Montvale 5101361, New Jersey 5101760 07645
Contact:
Alina K Markova, MD
646-608-2342

Memorial Sloan Kettering Cancer Center @ Commack (Consent only)
Commack 5113412, New York 5128638 11725
Contact:
Alina K Markova, MD
646-608-2342

Memorial Sloan Kettering Westchester (Consent only)
Harrison 5120095, New York 5128638 10604
Contact:
Alina Markova, MD
646-608-2342

Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York 5128581, New York 5128638 10065
Contact:
Alina Markova, MD
646-608-2342

Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)
Uniondale 5141927, New York 5128638 11553
Contact:
Alina K Markova, MD, PhD
646-608-2342

University of Pittsburgh Medical Center (Data Collection Only)
Pittsburgh 5206379, Pennsylvania 6254927 15213
Contact:
Annie Im, MD
412-864-7764
imap@upmc.edu

More Details

Status
Recruiting
Sponsor
Memorial Sloan Kettering Cancer Center

Study Contact

Alina Markova, MD
6466082342
markovaa@mskcc.org