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Cyclosporine Eye Drops in Preventing Graft-Versus-Host Disease of the Eye in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer or Bone Marrow Failure Disorder - NCT00755040-37064A(Clinical Trial 242476)



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City:  Nashville
State:  
TN
Zip Code: 37064
Conditions: Chronic Myeloproliferative Disorders - Graft Versus Host Disease - Leukemia - Lymphoma - Multiple Myeloma and Plasma Cell Neoplasm - Myelodysplastic Syndromes - Myelodysplastic/Myeloproliferative Neoplasms
Purpose: RATIONALE: Cyclosporine eye drops may prevent graft-versus-host disease of the eye in patients who have undergone donor stem cell transplant for hematologic cancer or bone marrow failure disorder. PURPOSE: This randomized phase I trial is studying how well cyclosporine eye drops work in preventing graft-versus-host disease of the eye in patients who have undergone donor stem cell transplant for hematologic cancer or bone marrow failure disorder.
Study summary: OBJECTIVES: Primary - To assess the efficacy of cyclosporine ophthalmic emulsion (Restasis®) in the prevention of ocular graft-versus-host disease in patients who have undergone allogeneic stem cell transplantation for hematologic malignancies or bone marrow failure disorders. Secondary - To correlate the Ocular Surface Disease Index with clinical ophthalmologic examination. OUTLINE: This is a multicenter study. Patients are stratified according to age, type of transplant (related vs unrelated), and intensity of transplant (ablative vs other). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant. - Arm II: Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant. Patients in both arms may also receive artificial tear drops at least twice daily as clinically necessary.
Criteria: DISEASE CHARACTERISTICS: - Diagnosis of hematologic malignancy or bone marrow failure disorder - Has undergone allogeneic stem cell transplantation within the past 80-120 days - No diagnosis of ocular graft-versus-host disease (GVHD) - No grade 4 acute GVHD - No relapse of underlying disease PATIENT CHARACTERISTICS: - Life expectancy ≥ 6 months - No documented dry eye prior to undergoing stem cell transplantation - No history of documented ocular infections prior to or during stem cell transplantation - No significant non-GVHD ocular problem that would preclude study participation - No history of non-compliance PRIOR CONCURRENT THERAPY: - See Disease Characteristics
Study is available at: Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, TN 37064
United States

Primary Contact:
Madan Jagasia
Phone: 615-322-1770
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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