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:
Vanderbilt-Ingram Cancer Center
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
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Purpose
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 | Intervention | 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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial acute myeloid leukemia with mutated CEBPA
primary myelofibrosis
MedlinePlus related topics:
Acute Myeloid Leukemia
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Eye Diseases
Leukemia
Lymphoma
Multiple Myeloma
Myelodysplastic Syndromes
Drug Information available for:
Cyclosporine
U.S. FDA Resources
Further study details as provided by Vanderbilt-Ingram Cancer Center:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- Correlation between Ocular Surface Disease Index (OSDI)and ophthalmologic examination [ Time Frame: 1 year after transplant ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 256 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | July 2016 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
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: Arm II
Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.
|
Other: placebo
Given as eye drops
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00755040
Contacts
| Contact: VICC Clinical Trials Information Program | 800-811-8480 |
Locations
| United States, California | |
| Stanford University | Recruiting |
| Palo Alto, California, United States, 94305 | |
| Contact: Joanne Otani 650-721-2372 jfehling@standord.edu | |
| Principal Investigator: Laura Johnston, MD | |
| United States, Illinois | |
| Norwestern Memorial Hospital | Not yet recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Lori Ackatz, RN 312-695-2333 | |
| Contact: Pam Conley 312-503-2558 | |
| Principal Investigator: Sandra Basti, MD | |
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center - Cool Springs | Recruiting |
| Nashville, Tennessee, United States, 37064 | |
| Contact: VICC Clinical Trials Information Program 800-811-8480 | |
| Principal Investigator: Madan Jagasia, MD | |
| Vanderbilt-Ingram Cancer Center at Franklin | Recruiting |
| Nashville, Tennessee, United States, 37064 | |
| Contact: VICC Clinical Trials Information Program 800-811-8480 | |
| Principal Investigator: Madan Jagasia, MD | |
| Vanderbilt-Ingram Cancer Center | Recruiting |
| Nashville, Tennessee, United States, 37232-6838 | |
| Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 | |
| Principal Investigator: Madan Jagasia, MD | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | Recruiting |
| Seattle, Washington, United States, 989109 | |
| Contact: Katie Laigo 206-667-6830 klaigo@fhcrc.org | |
| Principal Investigator: Mary Flowers, MD | |
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
| Principal Investigator: | Madan Jagasia, MD | Vanderbilt-Ingram Cancer Center |
More Information
Additional Information:
No publications provided by Vanderbilt-Ingram Cancer Center
Additional 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, VU-VICC-BMT-0766, VU-080786 |
| Study First Received: | September 17, 2008 |
| Last Updated: | May 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Vanderbilt-Ingram Cancer Center:
|
myelodysplastic/myeloproliferative neoplasm, unclassifiable 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 |
Additional relevant MeSH terms:
|
Myeloproliferative Disorders Myelodysplastic-Myeloproliferative Diseases Neoplasms Graft vs Host Disease Leukemia Lymphoma Lymphoma, Non-Hodgkin Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myelodysplastic Syndromes Preleukemia Lymphoma, Large-Cell, Immunoblastic Immune System Diseases Neoplasms by Histologic Type |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Precancerous Conditions Cyclosporins Cyclosporine Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013