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

Graft-Versus-Host Disease Clinical Trial

— HSCT  

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 Details — Status: Completed

Administrative data

• NCT number: NCT02144025
• Other study ID #: HU-EICHO
• Status: Completed
• Phase: Phase 2
• First received: May 13, 2014
• Last updated: February 25, 2016
• Start date: May 2014
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Coordinación de Investigación en Salud
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Graft vs Host Disease
• Graft-Versus-Host Disease

Intervention

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

Locations

Country	Name	City	State
Mexico	Servicio de Hematologia Hospital Universitario Dr Jose Eleuterio Gonzalez	Monterrey	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relapse of hematologic disease prior to 12 months of ocular cyclosporine use	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.	12 months	Yes
Primary	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	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	1 year after engraftment	Yes
Secondary	Characteristics and clinical presentation of ocular graft versus host disease in patients receiving allogeneic bone marrow transplantation using a reduced intensity conditioning regimen	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	1 year	Yes