Clinical trial NCT02144025: Prevention of Ocular Graft-Versus-Host Disease With Topical Cyclosporine in Recipients of Allogeneic 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Graft-Versus-Host Disease
Keywords: Ocular Graft-Versus-Host-Disease
Topical Cyclosporine
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2014-05-21
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 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
timeFrame: 1 year after engraftment
Secondary outcomes:
measure: Characteristics and clinical presentation of ocular graft versus host disease in patients receiving allogeneic bone marrow transplantation using a reduced intensity conditioning regimen
timeFrame: 1 year
Other outcomes:
measure: Relapse of hematologic disease prior to 12 months of ocular cyclosporine use
timeFrame: 12 months
Locations:
city: Monterrey
country: Mexico
facility: Servicio de Hematologia Hospital Universitario Dr Jose Eleuterio Gonzalez
state: Nuevo Leon
Study officials:
affiliation: Hospital Universitario "Dr. José Eleuterio González"
name: Olga Cantu-Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
References: