Overview

This trial is active, not recruiting.

Conditions chronic myeloproliferative disorders, graft versus host disease, leukemia, lymphoma, multiple myeloma and plasma cell neoplasm, myelodysplastic syndromes, myelodysplastic/myeloproliferative neoplasms
Treatments cyclosporine ophthalmic emulsion, placebo
Phase phase 3
Sponsor Vanderbilt-Ingram Cancer Center
Collaborator National Cancer Institute (NCI)
Start date October 2008
End date October 2014
Trial size 165 participants
Trial identifier NCT00755040, P30CA068485, VICC BMT 0766, VU-080786, VU-VICC-BMT-0766

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.
cyclosporine ophthalmic emulsion
Given as eye drops
(Placebo Comparator)
Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.
placebo
Given as eye drops

Primary Outcomes

Measure
Number of patients that develop ocular GVHD while on study in the two arms (ocular cyclosporine (Restasis) vs. placebo)
time frame: 1 year after transplant.

Secondary Outcomes

Measure
Numerical score of Ocular Surface Disease Index (OSDI) and development or lack of ocular GVHD (by ophthalmologic examination) as measured by Odds ratio in a linear regression model.
time frame: 1 year after transplant

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Randomized Placebo Controlled Double Blind Study of Restasis Versus Placebo in Primary Prevention of Ocular GVHD After Allogeneic Stem Cell Transplantation
Principal investigator Madan Jagasia, MD
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 transplantation for hematologic malignancies or bone marrow failure disorders. Secondary - To correlate the Ocular Surface Disease Index with clinical ophthalmologic examination. OUTLINE: This is a multicenter study. Patients are stratified according to age, type of transplant (related vs unrelated), and intensity of transplant (ablative vs other). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant. - Arm II: Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant. Patients in both arms may also receive artificial tear drops at least twice daily as clinically necessary.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Vanderbilt-Ingram Cancer Center.