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

This study is currently recruiting participants.

Verified March 2013 by Vanderbilt-Ingram Cancer Center

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Madan Jagasia, MD, Vanderbilt-Ingram Cancer Center

ClinicalTrials.gov Identifier:

NCT00755040

First received: September 17, 2008

Last updated: May 11, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 17, 2008

Last Updated Date

May 11, 2013

Start Date ^ICMJE

October 2008

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Efficacy of cyclosporine ophthalmic emulsion (Restasis®) in the prevention of ocular graft-versus-host disease [ Time Frame: 1 year after transplant. ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Efficacy of cyclosporine ophthalmic emulsion (Restasis®) in the prevention of ocular graft-versus-host disease [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00755040 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Correlation between Ocular Surface Disease Index (OSDI)and ophthalmologic examination [ Time Frame: 1 year after transplant ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Correlation between Ocular Surface Disease Index and ophthalmologic examination [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Randomized Placebo Controlled Double Blind Study of Restasis Versus Placebo in Primary Prevention of Ocular GVHD After Allogeneic Stem Cell Transplantation

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.

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.

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 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

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

Intervention ^ICMJE

Drug: cyclosporine ophthalmic emulsion
Given as eye drops
Other: placebo
Given as eye drops

Study Arm (s)

Experimental: Arm I
Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.

Intervention: Drug: cyclosporine ophthalmic emulsion
Placebo Comparator: Arm II
Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.

Intervention: Other: placebo

Publications *

Dietrich-Ntoukas T, Cursiefen C, Westekemper H, Eberwein P, Reinhard T, Bertz H, Nepp J, Lawitschka A, Heiligenhaus A, Seitz B, Messmer EM, Meyer-ter-Vehn T, Basara N, Greinix H, Datiles MB, Lee SJ, Pavletic SZ, Wolff D. Diagnosis and treatment of ocular chronic graft-versus-host disease: report from the German-Austrian-Swiss Consensus Conference on Clinical Practice in chronic GVHD. Cornea. 2012 Mar;31(3):299-310.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

256

Estimated Completion Date

July 2016

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: VICC Clinical Trials Information Program

800-811-8480

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00755040

Other Study ID Numbers ^ICMJE

VICC BMT 0766, P30CA068485, VU-VICC-BMT-0766, VU-080786

Has Data Monitoring Committee

Yes

Responsible Party

Madan Jagasia, MD, Vanderbilt-Ingram Cancer Center

Study Sponsor ^ICMJE

Vanderbilt-Ingram Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Madan Jagasia, MD

Vanderbilt-Ingram Cancer Center

Information Provided By

Vanderbilt-Ingram Cancer Center

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top