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Completed

NCT Number: NCT02144025

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

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

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Key information

Conditions

Graft-Versus-Host Disease Graft vs Host Disease Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Servicio de Hematologia Hospital Universitario Dr Jose Eleuterio Gonzalez

Monterrey, Nuevo León, 64460, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who have written consent wishing to participate in the study
  • Patients who have received an allogeneic stem cell hematopoietic transplants performed with a reduced intensity conditioning regimen
  • >18 year old

Exclusion criteria

  • <18 year old
  • Patients not wishing to participate in the study or have
  • Patients who have received autologous stem cell hematopoietic transplants
  • Patients with history of rheumatologic diseases
  • Patients with a previous diagnosis of dry eye síndrome
  • Patients with previous eye surgery that disrupts corenal integrity

Treatment and study plan

cyclosporine

Drug

Use of topical cyclosporine (one drop of cyclosporine in each eye, twice a day for 12 months)

Other names: modusik A ofteno Brand

Primary outcomes

  1. 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:

    • 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).
    • 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.
    • There will be monthly evaluations with Schirmer test to asses tear quiality and detect dry eye syndrome.
    • Every three months the patient will have a complete optalmologic evaluation as describe before

Secondary outcomes

  1. 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

Other outcomes

  1. Relapse of hematologic disease prior to 12 months of ocular cyclosporine use

    Time frame: 12 months

    Patients who relapse after hematopoietic stem cell transplant prior to 12 months of continous ocular cyclosporine use will be evaluated for signs and symptoms of ocular GVHD and will be discarded from study because it is expected that systemic cyclosporine will also be suspended.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Other

Registry information

Official study 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

Acronym: HSCT

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 21, 2014
Registry last updated
Feb 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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