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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporine | Drug | Use of topical cyclosporine (one drop of cyclosporine in each eye, twice a day for 12 months) |
|
| 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:
| 1 year after engraftment |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olga Cantu-Rodriguez, MD | Hospital Universitario "Dr. José Eleuterio González" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Servicio de Hematologia Hospital Universitario Dr Jose Eleuterio Gonzalez | Monterrey | Nuevo León | 64460 | Mexico |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| 1 year |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |