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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult and pediatric patients who received an allogeneic stem cell transplant (allo-HCT) | Active Comparator | Participants are Allo-HCT recipients |
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| Adult and pediatric patients who received a placebo treatment | Placebo Comparator | Participants are Allo-HCT recipients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alina Markova, MD | Contact | 6466082342 | markovaa@mskcc.org | |
| Doris Ponce, MD | Contact | 646-608-3739 | ponced@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Alina Markova, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Health (Data Collection AND Specimen Analysis) | Recruiting | Bethesda | Maryland | 20892 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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• Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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This is a phase 2, double-blind, randomized (1:1 ratio) study
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Double-blind
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| 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 |
|
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| Memorial Sloan Kettering at Basking Ridge (Consent only) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
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| Memorial Sloan Kettering Monmouth (Consent only) | Recruiting | Middletown | New Jersey | 07748 | United States |
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| Memorial Sloan Kettering Cancer Center @ Bergen (Consent only) | Recruiting | Montvale | New Jersey | 07645 | United States |
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| Memorial Sloan Kettering Cancer Center @ Commack (Consent only) | Recruiting | Commack | New York | 11725 | United States |
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| Memorial Sloan Kettering Westchester (Consent only) | Recruiting | Harrison | New York | 10604 | United States |
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| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | Recruiting | New York | New York | 10065 | United States |
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| Memorial Sloan Kettering Cancer Center @ Nassau (Consent only) | Recruiting | Uniondale | New York | 11553 | United States |
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| University of Pittsburgh Medical Center (Data Collection Only) | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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