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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA068485 | U.S. NIH Grant/Contract | View source | |
| VU-VICC-BMT-0766 | |||
| VU-080786 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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
Secondary
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.
Patients in both arms may also receive artificial tear drops at least twice daily as clinically necessary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocular Cyclosporine (Restasis) | Experimental | Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant. |
|
| Placebo | Placebo Comparator | Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclosporine ophthalmic emulsion | Drug | Given as eye drops |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients That Develop Ocular GVHD While on Study in the Two Arms (Ocular Cyclosporine (Restasis) vs. Placebo) | 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. | Up to 2 years after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Madan Jagasia, MD | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94305 | United States | ||
| Norwestern Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22157574 | Derived | 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. |
| Label | URL |
|---|---|
| Vanderbilt-Ingram Cancer Center, Find a Clinical Trial | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I | Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant. cyclosporine ophthalmic emulsion: Given as eye drops |
| FG001 | Arm II |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo |
| Other |
Given as eye drops |
|
| 1 year after transplant |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6838 | United States |
| M. D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 989109 | United States |
Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.
placebo: Given as eye drops
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ocular Cyclosporine (Restasis) | Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant. cyclosporine ophthalmic emulsion: Given as eye drops |
| BG001 | Placebo | Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant. placebo: Given as eye drops |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients That Develop Ocular GVHD While on Study in the Two Arms (Ocular Cyclosporine (Restasis) vs. Placebo) | 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. | Number of patients that develop ocular GVHD while on study | Posted | Number | participants | Up to 2 years after transplantation |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Not collected/analysed due to staffing constraints | Posted | 1 year after transplant |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I | Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant. cyclosporine ophthalmic emulsion: Given as eye drops | 3 | 83 | 49 | 83 | ||
| EG001 | Arm II | Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant. placebo: Given as eye drops | 7 | 81 | 18 | 81 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood/Bone Marrow | Blood and lymphatic system disorders | Relapse of underlying disease |
| ||
| Multi-organ failure | General disorders |
| |||
| Blood/Bone Marrow Other | Blood and lymphatic system disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burning | Eye disorders |
| |||
| Red eye | Eye disorders |
| |||
| Discharge | Eye disorders |
| |||
| Excessive tearing | Eye disorders |
| |||
| Eye pain | Eye disorders |
| |||
| Foreign Body Sensation | Eye disorders |
| |||
| Itching | Eye disorders |
| |||
| Stinging | Eye disorders |
| |||
| Visual disturbance | Eye disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Madan Jagasia, M.D. | Vanderbilt Ingram Cancer Center | (615) 936-8422 | madan.jagasia@vanderbilt.edu |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D006086 | Graft vs Host Disease |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| D009190 | Myelodysplastic Syndromes |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D002051 | Burkitt Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D015465 | Leukemia, Myeloid, Accelerated Phase |
| D000013 | Congenital Abnormalities |
| D054438 | Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
| D001752 | Blast Crisis |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| C580364 | Pdgfra-Associated Chronic Eosinophilic Leukemia |
| D055728 | Primary Myelofibrosis |
| D015467 | Leukemia, Neutrophilic, Chronic |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007154 | Immune System Diseases |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D007951 | Leukemia, Myeloid |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002471 | Cell Transformation, Neoplastic |
| D063646 | Carcinogenesis |
| D009385 | Neoplastic Processes |
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| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| >=65 years |
|
| Male |
|