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

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

In brief

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.

Key facts

Study ID

NCT00755040

Run by

Vanderbilt-Ingram Cancer Center

People needed

164

Starts

2008-10-01

Expected to finish

2016-05-01

Last updated by the study team

2017-03-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University — Palo Alto, California, United States
• Norwestern Memorial Hospital — Chicago, Illinois, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• M. D. Anderson Cancer Center — Houston, Texas, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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