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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05675930

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

4.9

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Graft-Versus-Host Disease GVHD Undefined	Device: Photobiomodulation Therapy Other: Placebo sham device	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a phase 2, double-blind, randomized (1:1 ratio) studyThis is a phase 2, double-blind, randomized (1:1 ratio) study

Masking:

Double (Participant, Care Provider)

Masking Description:

Double-blind

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Dec 22, 2022

Anticipated Primary Completion Date :

Dec 22, 2023

Anticipated Study Completion Date :

Dec 22, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Response rate of participants [28 days]
To assess the primary objective, we will compare the treatment response rates, defined as the the proportion of oral GvHD allo-HCT patients who achieve a CR or a PR at Day 28, for the PBM and Placebo arms. The treatment response rate will be calculated within each study arm for all patients who completed at least one PBM or placebo treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institute of Health (Data Collection AND Specimen Analysis)	Bethesda	Maryland	United States	20892
2	Memorial Sloan Kettering at Basking Ridge (Consent only)	Basking Ridge	New Jersey	United States	07920
3	Memoral Sloan Kettering Monmouth (Consent only)	Middletown	New Jersey	United States	07748
4	Memorial Sloan Kettering Cancer Center @ Bergen (Consent only)	Montvale	New Jersey	United States	07645
5	Memorial Sloan Kettering Cancer Center @ Commack (Consent only)	Commack	New York	United States	11725
6	Memorial Sloan Kettering Westchester (Consent only)	Harrison	New York	United States	10604
7	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York	United States	10065
8	Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)	Uniondale	New York	United States	11553
9	University of Pittsburgh Medical Center (Data Collection Only)	Pittsburgh	Pennsylvania	United States	15213