Non Hodgkin Lymphoma Clinical Trial
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
Summary
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.
Full 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.
Eligibility Criteria
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
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There are 5 Locations for this study
Palo Alto California, 94305, United States
Chicago Illinois, 60611, United States
Nashville Tennessee, 37232, United States
Houston Texas, 77030, United States
Seattle Washington, 98910, United States
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