Back to resultsA Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant
Primary Purpose
Graft-Versus-Host Disease, GVHD, Undefined
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Photobiomodulation Therapy
Placebo sham device
Sponsored by
About this trial
This is an interventional treatment trial for Graft-Versus-Host Disease focused on measuring Graft-Versus-Host Disease, GVHD, Chronic Graft Versus Host Disease Oral, PhotobiomoduLatIon, Memorial Sloan Kettering Cancer Center, 22-271
Eligibility Criteria
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.
Sites / Locations
- National Institute of Health (Data Collection AND Specimen Analysis)Recruiting
- Memorial Sloan Kettering at Basking Ridge (Consent only)Recruiting
- Memorial Sloan Kettering Monmouth (Consent only)Recruiting
- Memorial Sloan Kettering Cancer Center @ Bergen (Consent only)Recruiting
- Memorial Sloan Kettering Cancer Center @ Commack (Consent only)Recruiting
- Memorial Sloan Kettering Westchester (Consent only)Recruiting
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
- Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)Recruiting
- University of Pittsburgh Medical Center (Data Collection Only)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Adult and pediatric patients who received an allogeneic stem cell transplant (allo-HCT)
Adult and pediatric patients who received a placebo treatment
Arm Description
Participants are Allo-HCT recipients
Participants are Allo-HCT recipients
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05675930
First Posted
December 22, 2022
Last Updated
September 15, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05675930
Brief Title
A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2022 (Actual)
Primary Completion Date
December 22, 2025 (Anticipated)
Study Completion Date
December 22, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This is a phase 2, double-blind, randomized (1:1 ratio) study
Masking
ParticipantCare Provider
Masking Description
Double-blind
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adult and pediatric patients who received an allogeneic stem cell transplant (allo-HCT)
Arm Type
Active Comparator
Arm Description
Participants are Allo-HCT recipients
Arm Title
Adult and pediatric patients who received a placebo treatment
Arm Type
Placebo Comparator
Arm Description
Participants are Allo-HCT recipients
Intervention Type
Device
Intervention Name(s)
Photobiomodulation Therapy
Other Intervention Name(s)
PBM Therapy, Thor LX2.3 system device
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo sham device
Other Intervention Name(s)
Thor LX2.3 sham device setting
Intervention Description
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 Information:
Title
Response rate of participants
Description
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.
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alina Markova, MD
Phone
6466082342
Email
markovaa@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Doris Ponce, MD
Phone
646-608-3739
Email
ponced@mskcc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alina Markova, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Health (Data Collection AND Specimen Analysis)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacqueline Mays, DDS, MHSc, PhD
Phone
(301) 496-8800
Email
jacqueline.mays@nih.gov
Facility Name
Memorial Sloan Kettering at Basking Ridge (Consent only)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alina Markova, MD
Phone
646-608-2342
Facility Name
Memorial Sloan Kettering Monmouth (Consent only)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alina Markova, MD
Phone
646-608-2342
Facility Name
Memorial Sloan Kettering Cancer Center @ Bergen (Consent only)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alina K Markova, MD
Phone
646-608-2342
Facility Name
Memorial Sloan Kettering Cancer Center @ Commack (Consent only)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alina K Markova, MD
Phone
646-608-2342
Facility Name
Memorial Sloan Kettering Westchester (Consent only)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alina Markova, MD
Phone
646-608-2342
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alina Markova, MD
Phone
646-608-2342
Facility Name
Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alina K Markova, MD, PhD
Phone
646-608-2342
Facility Name
University of Pittsburgh Medical Center (Data Collection Only)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annie Im, MD
Phone
412-864-7764
Email
imap@upmc.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
• 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.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant
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