Clinical Trial VICCBMT0766
Title
Randomized Placebo Controlled Double Blind Study of Restasis Versus Placebo in Primary Prevention of Ocular GVHD After Allogeneic Stem Cell Transplantation
Principal Investigator(s)
Details
- Protocol No. VICCBMT0766
- Open Date: 10/23/2008
- Staging: Phase III
- Age Group: Adults
- Scope: Local
- Objective: To assess the efficacy of topical cyclosporine drops (Restasis) in the prevention of ocular GVHD
- Disease Sites: Bone Marrow Transplant
- Therapies: None Specified
- Drugs: Restasis
- Participating Institutions: Northwestern Memorial Hospital; Stanford University; Fred Hutchinson Cancer Research Center; M.D. Anderson Cancer Center, Houston; Vanderbilt University
- National Clinical Trial ID: NCT00755040
- Secondary Protocol No: Not Specified
Description
Patients are being asked to take part in this research study because they have had a stem cell transplant from a donor (related or unrelated). They are at risk of getting chronic graft-versus-host disease (cGVHD). Ocular GVHD also known as dry eye is one of the symptoms of cGVHD. The purpose of this study is to see how effective Restasis- is in the prevention of ocular GVHD.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
|---|---|
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Learn More
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