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
Laura Johnston

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Wen-Kai Weng, MD, PhD
Wen-Kai Weng, MD, PhD

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology

Robert Lowsky
Robert Lowsky

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Robert Negrin
Robert Negrin

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Sally Arai
Sally Arai

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Judith Shizuru
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

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