Clinical trial NCT01118845 (phase 2, status: completed)
Conditions: non-hodgkin's lymphoma, lymphoma, large cell, diffuse, mantle cell lymphoma, lymphoma, follicular lymphoma, large b-cell, diffuse
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: syb l-0501, rituximab
SMILES: CN1C(CCCC(O)=O)=NC2=CC(=CC=C12)N(CCCl)CCCl, ClCCN(CCCl)P1(=O)NCCCO1
Eligibility 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