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:
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

September 17, 2008
May 11, 2013
October 2008
December 2015   (final data collection date for primary outcome measure)
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 ]
Efficacy of cyclosporine ophthalmic emulsion (Restasis®) in the prevention of ocular graft-versus-host disease [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00755040 on ClinicalTrials.gov Archive Site
Correlation between Ocular Surface Disease Index (OSDI)and ophthalmologic examination [ Time Frame: 1 year after transplant ] [ Designated as safety issue: No ]
Correlation between Ocular Surface Disease Index and ophthalmologic examination [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
Randomized Placebo Controlled Double Blind Study of Restasis Versus Placebo in Primary Prevention of Ocular GVHD After Allogeneic Stem Cell Transplantation

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.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Chronic Myeloproliferative Disorders
  • Graft Versus Host Disease
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • Drug: cyclosporine ophthalmic emulsion
    Given as eye drops
  • Other: placebo
    Given as eye drops
  • 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
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. doi: 10.1097/ICO.0b013e318226bf97.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
256
July 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: VICC Clinical Trials Information Program 800-811-8480
United States
 
NCT00755040
VICC BMT 0766, P30CA068485, VU-VICC-BMT-0766, VU-080786
Yes
Madan Jagasia, MD, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Madan Jagasia, MD Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
March 2013

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