Phase III Study of SyB L-0501 in Combination With Rituximab to Treat Recurrent/Relapsed 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 Day 2 and Day 3 in combination with rituximab at 375 mg/m^2 on Day 1 of each 21-day cycle in patients with recurrent/relapsed diffuse large B-cell lymphoma.

Inclusion criteria

Patients who satisfy all of the conditions listed below.

• Patients with histopathologically confirmed diffuse large B-cell lymphoma (DLBCL) except for transformed lymphoma on the basis of World Health Organization (WHO) histological classification (4th ed., 2008).
• Patients with documented Cluster of differentiation 20 (CD20)-positive for lymphoma cells.
• Patient with recurrent or relapsed DLBCL after R-CHOP-like theraphy as the firstline therapy.
• Patients with measurable lesions >1.5 cm in major axes.
• Patients who are expected to survive for at least 3 months.
• Patients aged 20 or above at the time informed consent is obtained.
• Patient with Performance Status (P.S.) 0-1.
• Patients with adequately maintained organ function.

Exclusion criteria

The study subject should be excluded if any one of the following condition exists.

• 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.
• Patient who received prior chemotherapy 3 regimens or more.
• Patients with central nervous system (CNS) involvement or patients with clinical symptoms suggestive of CNS involvement.
• Patient with serious active infection.
• Patient with serious complication.
• Patient with complication or medical history of serious cardiac disease.
• Patient with serious gastrointestinal symptoms.
• Patient with malignant pleural effusion, pericardial effusion, or ascites retention.
• Patients positive for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody, or HIV antibody.
• Patient with serious bleeding tendency.
• Patient 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.
• Patient who received bendamustin hydrochloride 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.