Study of SyB L-0501 in Combination With Rituximab to Treat Relapsed/Refractory Diffuse Large B-Cell Lymphoma

A Multinational, Multicenter, Open-Label Phase II Study of SyB L-0501 in Combination With Rituximab in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

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.

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