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

Primary Purpose

Graft-Versus-Host Disease

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Cyclosporine
Sponsored by
Hospital Universitario Dr. Jose E. Gonzalez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Graft-Versus-Host Disease focused on measuring Ocular Graft-Versus-Host-Disease, Topical Cyclosporine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Servicio de Hematologia Hospital Universitario Dr Jose Eleuterio Gonzalez

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Topical cyclosporine

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 13, 2014
Last Updated
February 25, 2016
Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
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1. Study Identification

Unique Protocol Identification Number
NCT02144025
Brief Title
Prevention of Ocular Graft-Versus-Host Disease With Topical Cyclosporine in Recipients of Allogeneic HSCT
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Dr. Jose E. Gonzalez

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft-Versus-Host Disease
Keywords
Ocular Graft-Versus-Host-Disease, Topical Cyclosporine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topical cyclosporine
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Cyclosporine
Other Intervention Name(s)
modusik A ofteno Brand
Intervention Description
Use of topical cyclosporine (one drop of cyclosporine in each eye, twice a day for 12 months)
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
1 year after engraftment
Secondary Outcome Measure Information:
Title
Characteristics and clinical presentation of ocular graft versus host disease in patients receiving allogeneic bone marrow transplantation using a reduced intensity conditioning regimen
Description
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
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Relapse of hematologic disease prior to 12 months of ocular cyclosporine use
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olga Cantu-Rodriguez, MD
Organizational Affiliation
Hospital Universitario "Dr. José Eleuterio González"
Official's Role
Principal Investigator
Facility Information:
Facility Name
Servicio de Hematologia Hospital Universitario Dr Jose Eleuterio Gonzalez
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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