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NCT05675930 Clinical Trial

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

Graft-Versus-Host Disease Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05675930
Other study ID # 22-271
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date December 22, 2022
Est. completion date December 22, 2025

Study information
Verified date June 2024
Source Memorial Sloan Kettering Cancer Center
Contact Alina Markova, MD
Phone 6466082342
Email markovaa@mskcc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 44
Est. completion date December 22, 2025
Est. primary completion date December 22, 2025
Accepts healthy volunteers No
Gender All
Age group 4 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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:
• 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

Locations
Country Name City State
United States Memorial Sloan Kettering at Basking Ridge (Consent only) Basking Ridge New Jersey
United States National Institute of Health (Data Collection AND Specimen Analysis) Bethesda Maryland
United States Memorial Sloan Kettering Cancer Center @ Commack (Consent only) Commack New York
United States Memorial Sloan Kettering Westchester (Consent only) Harrison New York
United States Memorial Sloan Kettering Monmouth (Consent only) Middletown New Jersey
United States Memorial Sloan Kettering Cancer Center @ Bergen (Consent only) Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York
United States University of Pittsburgh Medical Center (Data Collection Only) Pittsburgh Pennsylvania
United States Memorial Sloan Kettering Cancer Center @ Nassau (Consent only) Uniondale New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
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Completed NCT00993343 - Randomized Trial Comparing Sirolimus and Tacrolimus Versus Cyclosporine and Methotrexate as Graft-versus-host Disease (GVHD) Prophylaxis After Allogeneic Stem Cell Transplantation Phase 3
Completed NCT00360685 - Tacrolimus and Mycophenolate Mofetil (MMF) in GVHD Prophylactic Regimen Compared to Tacrolimus and Methotrexate (MTX N/A
Active, not recruiting NCT04503616 - Cyclophosphamide, Abatacept, and Tacrolimus for GvHD Prevention Phase 1/Phase 2
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Completed NCT02193880 - Safety of Post-transplant Alpha-beta Depleted T-cell Infusion Following Haploidentical Stem Cell Transplant (Haplo SCT) N/A
Completed NCT02942173 - CD45RA Depleted T-cell Infusion for Prevention of Infections After TCRab/CD19-depleted Allo-HSCT Phase 2/Phase 3
Completed NCT02145403 - Phase 1/2 Study of Carfilzomib for the Prevention of Relapse and GVHD in Allo-HCT for Hematologic Malignancies Phase 1/Phase 2
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Completed NCT00141713 - The Use of Etanercept (Enbrel®) in the Treatment of Acute Graft-Versus-Host Disease Phase 2
Recruiting NCT01991301 - Carfilzomib for the Prevention of Graft Versus Host Disease Phase 1
Completed NCT00408928 - Study on the Safety and Effectiveness of VELCADE® in the Treatment of Graft-Versus-Host Disease Phase 2
Completed NCT01633229 - Bone Marrow Stromal Cell Infusions for Stem Cell Transplant Complications Phase 1
Completed NCT05856058 - To Assess SHR0302 Oral Solutions and Tablets in Healthy Subjects Clinical Studies of Relative Bioavailability Phase 1
Completed NCT02342613 - Adoptive Immunotherapy With Activated Marrow Infiltrating Lymphocytes and Cyclophosphamide Graft-Versus-Host Disease Prophylaxis in Patients With Relapse of Hematologic Malignancies After Allogeneic Hematopoietic Cell Transplantation Phase 1
Recruiting NCT06423131 - Prospective Clinical Trial for Children With TCRαβ Depleted vs Traditional Haplo Identicle HSCT N/A
Completed NCT02144025 - Prevention of Ocular Graft-Versus-Host Disease With Topical Cyclosporine in Recipients of Allogeneic HSCT Phase 2
Completed NCT01369914 - The Natural History of Graft-Versus-Host Disease in the Eyes
Completed NCT00806728 - Study of MEDI-507 in With Steroid-Resistant Acute Graft-Versus-Host Disease Phase 1

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