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

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

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.

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclosporine; Cyclosporins; Ophthalmic Solutions; Tetrahydrozoline

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