Status:
COMPLETED
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
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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. PU...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT00755040
Start Date
October 1 2008
End Date
May 1 2016
Last Update
March 7 2017
Active Locations (5)
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1
Stanford University
Palo Alto, California, United States, 94305
2
Norwestern Memorial Hospital
Chicago, Illinois, United States, 60611
3
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
4
M. D. Anderson Cancer Center
Houston, Texas, United States, 77030