Clinical Trial: Prevention of Ocular Graft-Versus-Host Disease With Topical Cyclosporine in Recipients of Allogeneic HSCT

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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


Detailed Summary:

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.


Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

Current Primary Outcome: Ocular graft versus host disease is manifested by dry eye syndrome and disruptions in corneal integrity. The study will asses the efficacy of topical cyclosporine for preventing OGVHD manifestations [ Time Frame: 1 year after engraftment ]

The patient will start using ocular topical cyclosporine at the day of engraftment (around 14-16 days after cell infusion) and will continue to use it for one year.

The following landmarks will be evaluated:

  1. First evaluation of a new patient with the ophtalmologist: The patient will be evaluated by a qualified ophtalmologist before the allogeneic stem cell transplant with the following tests: Corneal integrity (yes or no), Schirmer test (mm), tear break up time (seconds).
  2. Immediately after engraftment has occured (around 14-16 days after cell infusion) the patient will start using topical cyclosporine and will continue to use it for one year.
  3. There will be monthly evaluations with Schirmer test to asses tear quiality and detect dry eye syndrome.
  4. Every three months the patient will have a complete optalmologic evaluation as describe before


Original Primary Outcome: Same as current

Current Secondary Outcome: Characteristics and clinical presentation of ocular graft versus host disease in patients receiving allogeneic bone marrow transplantation using a reduced intensity conditioning regimen [ Time Frame: 1 year ]

The secondary outcome of the study is to asses the clinical characteristics of ocular graft versus host disease in patients receiving allogeneic stem cell transplants performed with a reduced intensity conditioning regimen


Original Secondary Outcome: Same as current

Information By: Hospital Universitario Dr. Jose E. Gonzalez

Dates:
Date Received: May 13, 2014
Date Started: May 2014
Date Completion:
Last Updated: February 25, 2016
Last Verified: February 2016