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

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

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.

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 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

Keywords: 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 noncontiguous stage ii adult burkitt lymphoma noncontiguous stage ii adult diffuse large cell lymphoma noncontiguous stage ii adult diffuse mixed cell lymphoma noncontiguous stage ii adult diffuse small cleaved cell lymphoma noncontiguous stage ii adult immunoblastic large cell lymphoma noncontiguous stage ii adult lymphoblastic lymphoma noncontiguous stage ii grade 1 follicular lymphoma noncontiguous stage ii grade 2 follicular lymphoma noncontiguous stage ii grade 3 follicular lymphoma noncontiguous stage ii mantle cell lymphoma noncontiguous stage ii marginal zone lymphoma noncontiguous stage ii small lymphocytic lymphoma accelerated phase chronic myelogenous leukemia adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission adult acute myeloid leukemia with 11q23 (mll) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) atypical chronic myeloid leukemia, bcr-abl negative blastic phase chronic myelogenous leukemia chronic myelomonocytic leukemia chronic phase chronic myelogenous leukemia secondary acute myeloid leukemia stage iii chronic lymphocytic leukemia stage iv chronic lymphocytic leukemia chronic eosinophilic leukemia primary myelofibrosis chronic neutrophilic leukemia de novo myelodysplastic syndromes myelodysplastic/myeloproliferative neoplasm, unclassifiable previously treated myelodysplastic syndromes secondary myelodysplastic syndromes stage i multiple myeloma stage ii multiple myeloma stage iii multiple myeloma