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Graft Versus Host Disease

Restasis® Versus Placebo in Primary Prevention of Ocular GVHD After Allogeneic SCT
A Randomized Placebo Controlled Double-Blind Study of Restasis® Versus Placebo in Primary Prevention of Ocular GVHD After Allogeneic Stem Cell Transplantation
Status Conditions Phase Study ID
Closed Chronic Graft Versus Host Disease (cGVHD) Phase I 2321.00
NCT00755040
Summary

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. 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.


Investigator
Mary Flowers, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • 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
Exclusions (conditions that would prevent participation in this study)
  • 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
Last Updated
May 12, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.