Recruiting
Phase 2

Photobiomodulation

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05675930

Conditions

Graft-Versus-Host Disease

GVHD

Undefined

Eligibility Criteria

Sex: All

Age: 4+

Healthy Volunteers: Not accepted

Interventions

Photobiomodulation Therapy

Placebo sham device

Study Details

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

Study ID

NCT05675930

Start date

Dec 22, 2022

Status verified date

May, 2026

Completion date

Dec 22, 2026

Anticipated

Primary completion date

Dec 22, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4+

Healthy Volunteers: Not accepted

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

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Participants are Allo-HCT recipients

placebo comparator: Adult and pediatric patients who received a placebo treatment

Participants are Allo-HCT recipients

Interventions

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

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

Primary outcome measure

  • Response rate of participants [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

Alina Markova, MD

6466082342markovaa@mskcc.org

Doris Ponce, MD

646-608-3739ponced@mskcc.org

Locations

National Institute of Health (Data Collection AND Specimen Analysis)

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

Jacqueline Mays, DDS, MHSc, PhD

(301) 496-8800jacqueline.mays@nih.gov

Memorial Sloan Kettering at Basking Ridge (Consent only)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Alina Markova, MD

646-608-2342

Memorial Sloan Kettering Monmouth (Consent only)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Alina Markova, MD

646-608-2342

Memorial Sloan Kettering Cancer Center @ Bergen (Consent only)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Alina K Markova, MD

646-608-2342

Memorial Sloan Kettering Cancer Center @ Commack (Consent only)

Recruiting

Commack, New York, United States, 11725

Contacts

Alina K Markova, MD

646-608-2342

Memorial Sloan Kettering Westchester (Consent only)

Recruiting

Harrison, New York, United States, 10604

Contacts

Alina Markova, MD

646-608-2342

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Alina Markova, MD

646-608-2342

Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Alina K Markova, MD, PhD

646-608-2342

University of Pittsburgh Medical Center (Data Collection Only)

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Annie Im, MD

412-864-7764imap@upmc.edu

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • Graft-Versus-Host Disease
  • GVHD
  • Chronic Graft Versus Host Disease Oral
  • PhotobiomoduLatIon
  • Memorial Sloan Kettering Cancer Center
  • 22-271

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-05-22.