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Prevention of Ocular Graft-Versus-Host Disease With Topical Cyclosporine in Recipients of Allogeneic HSCT — HSCT  

Graft-Versus-Host Disease Clinical Trial

Official title:
Prevention of Ocular Graft-Versus Host Disease With Topical Cyclosporine in Recipients of Allogeneic Hematopoietic Stem Cell Transplants Performed With a Reduced Intensity Conditioning Regimen

Clinical Trial Summary

Ocular Graft Versus Host Disease (OGVHD) is a serious potential complication of allogeneic bone marrow transplants. The usual treatment is topical cyclosporine but when the treatment is initiated the damage to the lacrimal glands has already taken place.

The present study aims to prevent OGVHD in reduced-intensity allogeneic hematopoietic transplants by using topical cyclosporine immediately after the engraftment has been achieved

Clinical Trial Description

The patient will start using topical cyclosporine immediately after engraftment has taken place (around day 14-18 after the cell infusion) and will continue to receive it for one year.

All >18 year old patients receiving allogeneic stem cell transplants performed with a reduced intensity conditioning regimen at our center are potential candidates for the study.

The purpose of the study is to evaluate the efficacy of topical cyclosporine in prevention of ocular versus graft disease when its use is indicated immediately after the engraftment has occured. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02144025
Study type Interventional
Source Hospital Universitario Dr. Jose E. Gonzalez
Contact
Status Completed
Phase Phase 2
Start date May 2014
Completion date February 2016
View Details
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