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

SymBio Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Diffuse, Mantle Cell Lymphoma, Lymphoma

Large B-Cell, Diffuse

Lymphoma, Large Cell

Non-Hodgkin's Lymphoma

Follicular Lymphoma

Treatments

Drug: Rituximab

Drug: SyB L-0501

Study type

Interventional

Funder types

Industry

Identifiers

NCT01118845

2010001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

63 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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