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

Last updated: January 24, 2017
Sponsor: Vanderbilt-Ingram Cancer Center
Overall Status: Completed

Phase

3

Condition

Leukemia

Cancer/tumors

Hematologic Cancer

Treatment

N/A

Clinical Study ID

NCT00755040
VICC BMT 0766
VU-080786
P30CA068485
VU-VICC-BMT-0766
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 acuteGVHD, florid progression or relapse of underlying disease)

  • history of documented ocular infections prior to stem cell transplant or duringtransplant (i.e. history of herpetic keratitis)

  • females who are pregnant or breastfeeding

Study Design

Total Participants: 164
Study Start date:
October 01, 2008
Estimated Completion Date:
May 31, 2016

Study 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.

Connect with a study center

  • Stanford University

    Palo Alto, California 94305
    United States

    Site Not Available

  • Norwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee 37232-6838
    United States

    Site Not Available

  • M. D. Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington 989109
    United States

    Site Not Available

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