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

Hospital Universitario Dr. Jose E. Gonzalez

Status and phase: Completed; Phase 2

Conditions: Graft-Versus-Host Disease

Treatments: Drug: Cyclosporine

Study type: Interventional

Funder types: Other

Identifiers

NCT02144025

HU-EICHO

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Topical cyclosporine

Experimental group

Description:

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.

Treatment:

Drug: Cyclosporine