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

NCT ID: NCT02144025

Last Updated: 2016-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-02-29

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 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.

Conditions

Graft-Versus-Host Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Topical cyclosporine

This is a single arm study of patients who have received allogeneic bone marrow transplants performed with a reduced intensity conditioning regimen. In this arm, patients who are candidates to this trial, will receive topical cyclosporine twice a day for 12 months to prevent ocular graft versus host disease.

Group Type: EXPERIMENTAL

Cyclosporine

Intervention Type: DRUG

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

Interventions

Cyclosporine

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

Intervention Type: DRUG

Other Intervention Names

modusik A ofteno Brand

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Dr. Jose E. Gonzalez

OTHER

Sponsor Role: lead

Responsible Party

Dra. Olga Graciela Cantu Rodriguez

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olga Cantu-Rodriguez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario "Dr. José Eleuterio González"

Locations

Servicio de Hematologia Hospital Universitario Dr Jose Eleuterio Gonzalez

Monterrey, Nuevo León, Mexico

Countries

Mexico

Other Identifiers

HU-EICHO

Identifier Type: -

Identifier Source: org_study_id