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NCT05675930 · ClinicalTrials.gov registry record · Phase 2
A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant
A Phase 2 study of Graft-Versus-Host Disease and GvHD, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
- 9
- Study locations
NCT05675930: Recruiting Phase 2 study of Graft-Versus-Host Disease and GvHD, sponsored by Memorial Sloan Kettering Cancer Center.
NCT05675930 is a Phase 2 study of Graft-Versus-Host Disease and GvHD that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 44 participants, below the 82-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (46% lower). The trial reports 9 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05675930, a Phase 2 study of Graft-Versus-Host Disease and GvHD, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
- 9
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Photobiomodulation Therapy
- OTHER Placebo sham device
Study Locations (9)
New York
- Memorial Sloan Kettering Cancer Center @ Commack (Consent only) - Commack
- Memorial Sloan Kettering Westchester (Consent only) - Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) - New York
- Memorial Sloan Kettering Cancer Center @ Nassau (Consent only) - Uniondale
New Jersey
- Memorial Sloan Kettering at Basking Ridge (Consent only) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Consent only) - Middletown
- Memorial Sloan Kettering Cancer Center @ Bergen (Consent only) - Montvale
Maryland
- National Institute of Health (Data Collection AND Specimen Analysis) - Bethesda
Pennsylvania
- University of Pittsburgh Medical Center (Data Collection Only) - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2022-12-22 |
| Est. Completion | 2026-12-22 |
| Phase | Phase 2 |
What NCT05675930 shows while recruiting
NCT05675930 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 82-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (46% lower).
The record links to 3 conditions, with Graft-Versus-Host Disease appearing as the primary indexed condition, and to 2 interventions - of which Photobiomodulation Therapy is the first listed.
NCT05675930 lists 9 locations in 4 states (New York, New Jersey, Maryland).
Frequently Asked Questions
What is clinical trial NCT05675930 about?
NCT05675930 is a clinical study titled "A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant". 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.
What is the current status of trial NCT05675930?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2022-12-22. Estimated completion is 2026-12-22.
What conditions does trial NCT05675930 study?
This clinical trial studies the following conditions: Graft-Versus-Host Disease, GvHD, Undefined.
What interventions are being tested in trial NCT05675930?
The interventions under investigation include: Photobiomodulation Therapy (DEVICE), Placebo sham device (OTHER).
Who is sponsoring clinical trial NCT05675930?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05675930 being conducted?
This trial has 9 study locations across Maryland, New Jersey, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05675930's enrollment target sits among peer trials
44 16th of 38 higher than 22 of 38 other Graft-Versus-Host Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Graft-Versus-Host Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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