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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

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ClinicalTrials.gov Identifier: NCT00755040
Recruitment Status : Completed
First Posted : September 18, 2008
Results First Posted : December 8, 2016
Last Update Posted : March 7, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Madan Jagasia, MD, Vanderbilt-Ingram Cancer Center

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Chronic Myeloproliferative Disorders Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Drug: cyclosporine ophthalmic emulsion Other: placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Placebo Controlled Double Blind Study of Restasis Versus Placebo in Primary Prevention of Ocular GVHD After Allogeneic Stem Cell Transplantation
Study Start Date : October 2008
Actual Primary Completion Date : December 2014
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
Genetic and Rare Diseases Information Center resources: Acute Lymphoblastic Leukemia Burkitt Lymphoma Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Myelodysplastic Syndromes Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Lymphosarcoma Multiple Myeloma Follicular Lymphoma B-cell Lymphoma Mantle Cell Lymphoma Diffuse Large B-Cell Lymphoma Hodgkin Lymphoma Marginal Zone Lymphoma Homologous Wasting Disease Chronic Myelomonocytic Leukemia Juvenile Myelomonocytic Leukemia Chronic Myeloid Leukemia Myelofibrosis Chronic Myeloproliferative Disorders Lymphoma, Large-cell Myelodysplastic/myeloproliferative Disease Lymphoblastic Lymphoma Plasmacytoma Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Chronic Neutrophilic Leukemia
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Ocular Cyclosporine (Restasis)
Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.
 Drug: cyclosporine ophthalmic emulsion
Given as eye drops
Placebo Comparator: Placebo
Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.
 Other: placebo
Given as eye drops


Outcome Measures
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Primary Outcome Measures :
  1. Number of Patients That Develop Ocular GVHD While on Study in the Two Arms (Ocular Cyclosporine (Restasis) vs. Placebo) [ Time Frame: Up to 2 years after transplantation ]
    Data analysis will be performed on an intention-to-treat basis. Logistic regression will be used to estimate the odds ratio and 95% confidence interval of the two treatment groups with the adjustment of baseline covariates. Outcome comparisons for categorical/dichotomous variables will be assessed by 2 test or Fisher's exact test where expected cell frequencies were <5; continuous variables will be compared by X/2 test or by Mann-Whitney U test where the data are strongly skewed.


Secondary Outcome Measures :
  1. 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 ]
    OSDI is a patient reported questionnaire consisting of 12 questions which are scored from 0 to 4. The total scored is computed and depending on the number of questions answered scores are computed which are then categorized into mild, moderate or severe dry eye symptoms. This tool should adequately reflect the morbidity of the dry eye symptoms.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00755040


Locations
United States, California
Stanford University
Palo Alto, California, United States, 94305
United States, Illinois
Norwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 989109
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Madan Jagasia, MD Vanderbilt-Ingram Cancer Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Vanderbilt-Ingram Cancer Center, Find a Clinical Trial  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Madan Jagasia, MD, Associate Professor of Medicine; Director, Outpatient Transplant Program; Section Chief, Hematology and Stem Cell Transplant; Hematologist/Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00755040     History of Changes
Other Study ID Numbers: VICC BMT 0766
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-BMT-0766
VU-080786
First Posted: September 18, 2008    Key Record Dates
Results First Posted: December 8, 2016
Last Update Posted: March 7, 2017
Last Verified: January 2017

Keywords provided by Madan Jagasia, MD, Vanderbilt-Ingram Cancer Center:
graft versus host disease
stage III adult Burkitt lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult Hodgkin lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III mantle cell lymphoma
stage III marginal zone lymphoma
stage III small lymphocytic lymphoma
stage IV adult Burkitt lymphoma
 stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult Hodgkin lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV mantle cell lymphoma
stage IV marginal zone lymphoma
stage IV small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma

Additional relevant MeSH terms:
Lymphoma
Syndrome
Leukemia
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Graft vs Host Disease
Myeloproliferative Disorders
Plasmacytoma
Myelodysplastic-Myeloproliferative Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Disease
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Cyclosporins
Cyclosporine