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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
Not Recruiting
Trial ID: NCT00755040
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.
Official Title
Randomized Placebo Controlled Double Blind Study of Restasis Versus Placebo in Primary Prevention of Ocular GVHD After Allogeneic Stem Cell Transplantation
Stanford Investigator(s)
Laura Johnston
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Wen-Kai Weng, MD, PhD
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology
Robert Lowsky
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Robert Negrin
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Sally Arai
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Judith Shizuru
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and of Pediatrics (Stem Cell Transplantation)
Eligibility
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
Intervention(s):
other: placebo
drug: cyclosporine ophthalmic emulsion
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Physician Referrals
650-723-0822