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

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SymBio Pharmaceuticals
• Treatments: Bendamustine Hydrochloride; Rituximab

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