Medpedia

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

DISEASE CHARACTERISTICS:
-  Diagnosis of hematologic malignancy or bone marrow failure disorder
-  Has undergone allogeneic stem cell transplantation within the past 80-120 days
-  No diagnosis of ocular graft-versus-host disease (GVHD)
-  No grade 4 acute GVHD
-  No relapse of underlying disease
PATIENT CHARACTERISTICS:
-  Life expectancy ≥ 6 months
-  No documented dry eye prior to undergoing stem cell transplantation
-  No history of documented ocular infections prior to or during stem cell
transplantation
-  No significant non-GVHD ocular problem that would preclude study participation
-  No history of non-compliance
PRIOR CONCURRENT THERAPY:
-  See Disease Characteristics

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.

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

• Efficacy of cyclosporine ophthalmic emulsion (Restasis®) in the prevention of ocular graft-versus-host disease
  Safety Issue: No
• Correlation between Ocular Surface Disease Index and ophthalmologic examination
  Safety Issue: No

• Madan Jagasia, MD
  Principal Investigator, Vanderbilt-Ingram Cancer Center

• Fred Hutchinson Cancer Research Center
  Seattle, Washington, 989109, United States
  Recruiting
  Contact Person

  (206) 667-4692
• M. D. Anderson Cancer Center at University of Texas
  Houston, Texas, 77030-4009, United States
  Recruiting
  Clinical Trials Office - M. D. Anderson Cancer Center at the U

  (713) 792-3245
• Vanderbilt-Ingram Cancer Center
  Nashville, Tennessee, 37232-6838, United States
  Recruiting
  Clinical Trials Office - Vanderbilt-Ingram Cancer Center

  (800) 811-8480
• Vanderbilt-Ingram Cancer Center at Franklin
  Nashville, Tennessee, 37064, United States
  Recruiting
  Madan Jagasia

  (615) 322-1770
• Vanderbilt-Ingram Cancer Center - Cool Springs
  Nashville, Tennessee, 37064, United States
  Recruiting
  Madan Jagasia

  (615) 322-1770

• Vanderbilt-Ingram Cancer Center
  Lead Sponsor
• Unspecified

• Clinical trial summary from the National Cancer Institute's PDQ® database
  http://cancer.gov/clinicaltrials/VU-VICC-BMT-0766