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

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

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

Study Overview

• Status: Completed
• Conditions: Graft-Versus-Host Disease
• Intervention / Treatment: Drug: Cyclosporine

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mexico
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64460
      • Servicio de Hematologia Hospital Universitario Dr Jose Eleuterio Gonzalez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Cyclosporine; Use of topical cyclosporine (one drop of cyclosporine in each eye, twice a day for 12 months); Other Names: modusik A ofteno Brand

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
• Investigators: Principal Investigator: Olga Cantu-Rodriguez, MD, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: May 13, 2014
• First Submitted That Met QC Criteria: May 16, 2014
• First Posted (Estimate): May 21, 2014

Study Record Updates

• Last Update Posted (Estimate): February 26, 2016
• Last Update Submitted That Met QC Criteria: February 25, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Ocular Graft-Versus-Host-Disease; Topical Cyclosporine
• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Calcineurin Inhibitors; Cyclosporine; Cyclosporins
• Other Study ID Numbers: HU-EICHO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO