study of syb l-0501 in combination with rituximab to treat relapsed/refractory diffuse large b-cell lymphoma

Conditions: Non-Hodgkin's Lymphoma; Lymphoma, Large Cell; Diffuse, Mantle Cell Lymphoma, Lymphoma; Follicular Lymphoma; Large B-Cell, Diffuse

Summary: the purpose of this study is to determine the efficacy of syb l-0501 in combination with rituximab in patients with relapsed/refractory diffuse large b-cell lymphoma.

primary objective is to determine the efficacy, as measured by overall response rate on the basis of revised response criteria for malignant lymphoma, of syb l-0501 at 120 mg/m\^2/day on day2 and 3 in combination with rituximab at 375 mg/m\^2 on day 1 of each 21-day cycle in patients with relapsed/refractory diffuse large b-cell lymphoma.

Eligibility criteria:
inclusion criteria: * patients with documented cluster of differentiation 20 (cd20)-positive for lymphoma cells * patients with measurable lesions * patients with measurable lesions \>1.5 cm in major axes * relapsed or refractory after 1 to 3 prior therapeutic treatments for diffuse large b-cell lymphoma. * patients who are expected to survive for at least 3 months * patients aged from 20 to 75 years at the time informed consent is obtained * performance status (p.s.) of 0 to 1 at initial administration of the study drug * patients with adequately maintained organ functions * patients capable of personally giving voluntary informed consent in writing to participate in the study exclusion criteria: * patients who have been without treatment for less than 3 weeks after prior treatment * patients who can be candidates for autologous peripheral blood stem cell transplantation at the discretion of the investigator. * patients who received adequate prior treatments and did not respond to any of them. * patients with central nervous system (cns) involvement or patients with clinical symptoms suggestive of cns involvement. * patients with serious, active infections * patients with serious complications * patients with complications or medical history of serious cardiac disease * patients with serious gastrointestinal symptoms * patients with malignant pleural effusion, cardiac effusion, or ascites retention * patients positive for hepatitis b surface (hbs) antigen, hepatitis c virus (hcv) antibody, or hiv antibody * patients with serious bleeding tendencies * patients with a fever of 38.0°c or higher * patients with, or confirmed in the past to have had, interstitial pneumonia, pulmonary fibrosis, or pulmonary emphysema * patients with active multiple primary cancer or patients with a history of other malignant cancer within the past 5 years, except for basal cell cancer of the skin, squamous cell cancer, or cervical cancer in situ * patients with, or confirmed in the past to have had, autoimmune hemolytic anemia * patients who received syb l-0501 in the past * patients who received cytokine preparation such as erythropoietin or granulocyte colony-stimulating factor (g-csf) or blood transfusions within 2 weeks before the examination at registration for this study * patients who received other investigational products or unapproved medication within 3 months before registration in this study

Keywords: non-hodgkin's lymphoma lymphoma, large b-cell diffuse, mantle cell lymphoma, lymphoma follicular, lymphoma large b-cell, diffuse