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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

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

NCT ID
NCT05675930
Status
Recruiting
Sponsor
Memorial Sloan Kettering Cancer Center

Study Contact

Alina Markova, MD
6466082342
markovaa@mskcc.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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