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
This trial is active, not recruiting.
|Conditions||chronic myeloproliferative disorders, graft versus host disease, leukemia, lymphoma, multiple myeloma and plasma cell neoplasm, myelodysplastic syndromes, myelodysplastic/myeloproliferative neoplasms|
|Treatments||cyclosporine ophthalmic emulsion, placebo|
|Sponsor||Vanderbilt-Ingram Cancer Center|
|Collaborator||National Cancer Institute (NCI)|
|Start date||October 2008|
|End date||October 2014|
|Trial size||165 participants|
|Trial identifier||NCT00755040, P30CA068485, VICC BMT 0766, VU-080786, VU-VICC-BMT-0766|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Palo Alto, CA||Stanford University||no longer recruiting|
|Chicago, IL||Norwestern Memorial Hospital||no longer recruiting|
|Nashville, TN||Vanderbilt-Ingram Cancer Center||no longer recruiting|
|Nashville, TN||Vanderbilt-Ingram Cancer Center - Cool Springs||no longer recruiting|
|Houston, TX||M. D. Anderson Cancer Center||no longer recruiting|
|Seattle, WA||Fred Hutchinson Cancer Research Center||no longer recruiting|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Number of patients that develop ocular GVHD while on study in the two arms (ocular cyclosporine (Restasis) vs. placebo)
time frame: 1 year after transplant.
Numerical score of Ocular Surface Disease Index (OSDI) and development or lack of ocular GVHD (by ophthalmologic examination) as measured by Odds ratio in a linear regression model.
time frame: 1 year after transplant
Male or female participants at least 18 years old.
Inclusion criteria: - Age greater than or equal to 18 years at time of enrollment - Day 80-120 after first allogeneic stem cell transplant for hematologic malignancies or -marrow failure disorder at time of study enrollment - Signed informed consent - Willing to adhere to protocol requirements Exclusion criteria: - history of non-compliance - diagnosis of ocular GVHD at time of study enrollment - documented dry eye prior to onset of stem cell transplant - significant non- GVHD ocular problems that precludes participation in study - life expectancy of lesser than 6 months at time of enrollment (viz. grade 4 acute GVHD, florid progression or relapse of underlying disease) - history of documented ocular infections prior to stem cell transplant or during transplant (i.e. history of herpetic keratitis) - females who are pregnant or breastfeeding
|Official title||Randomized Placebo Controlled Double Blind Study of Restasis Versus Placebo in Primary Prevention of Ocular GVHD After Allogeneic Stem Cell Transplantation|
|Principal investigator||Madan Jagasia, MD|
|Description||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.|
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