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
Inclusion Criteria:
- Patients with documented CD20-positive for lymphoma cells
- Patients with measurable lesions
- 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 38.0C 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