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

NCT02144025 | Completed Phase 2 DMC

• 1 other identifier: HU-EICHO
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

Graft-Versus-Host Disease

Keywords

Ocular Graft-Versus-Host-Disease; Topical Cyclosporine

Outcome Measures

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

  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: 1. 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). 2. 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. 3. There will be monthly evaluations with Schirmer test to asses tear quiality and detect dry eye syndrome. 4. Every three months the patient will have a complete optalmologic evaluation as describe before

  1 year after engraftment

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

  1 year

Other Outcomes (1)

• Relapse of hematologic disease prior to 12 months of ocular cyclosporine use

  12 months

Study Arms (1)

Topical cyclosporine

EXPERIMENTAL

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

Interventions

Cyclosporine DRUG

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

Also known as: modusik A ofteno Brand

Topical cyclosporine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Servicio de Hematologia Hospital Universitario Dr Jose Eleuterio Gonzalez

Monterrey, Nuevo León, 64460, Mexico

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Olga Cantu-Rodriguez, MD

  Hospital Universitario "Dr. José Eleuterio González"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 21, 2014
• Study Start: May 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 26, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)