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

NCT05675930 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 22-271
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 9

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.

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

Outcome Measures

Primary Outcomes (1)

• Response rate of participants

  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.

  28 days

Study Arms (2)

Adult and pediatric patients who received an allogeneic stem cell transplant (allo-HCT)

ACTIVE COMPARATOR

Participants are Allo-HCT recipients

Device: Photobiomodulation Therapy

Adult and pediatric patients who received a placebo treatment

PLACEBO COMPARATOR

Participants are Allo-HCT recipients

Other: Placebo sham device

Interventions

Photobiomodulation Therapy DEVICE

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

Also known as: PBM Therapy, Thor LX2.3 system device

Adult and pediatric patients who received an allogeneic stem cell transplant (allo-HCT)

Placebo sham device OTHER

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

Also known as: Thor LX2.3 sham device setting

Adult and pediatric patients who received a placebo treatment

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (9)

National Institute of Health (Data Collection AND Specimen Analysis)

Bethesda, Maryland, 20892, United States

RECRUITING

Memorial Sloan Kettering at Basking Ridge (Consent only)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Consent only)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Cancer Center @ Bergen (Consent only)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Cancer Center @ Commack (Consent only)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Consent only)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)

Uniondale, New York, 11553, United States

RECRUITING

University of Pittsburgh Medical Center (Data Collection Only)

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Alina Markova, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alina Markova, MD

CONTACT

6466082342; markovaa@mskcc.org

Doris Ponce, MD

CONTACT

646-608-3739; ponced@mskcc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 9, 2023
• Study Start: December 22, 2022
• Primary Completion (Estimated): December 22, 2026
• Study Completion (Estimated): December 22, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (9)