A Double-blind, Randomized Controlled Study in CD20-positive Diffuse B Cell Non-Hodgkin's Lymphoma Subjects

Inclusion criteria

• Newly diagnosed subjects with a confirmed pathologic diagnosis of diffuse large B cell non-Hodgkin's lymphoma (DLBCL) based on the 2008 World Health Organization classification.

2.CD20+ lymphoma cells at screening

• 18-80 (inclusive) years of age at screening
• Ann Arbor Stages I-IV at screening
• Any IPI score at screening
• ECOG good performance status (0-2) at screening
• Willing and able to provide written informed consent prior to performing study procedures
• Women of childbearing potential must use effective contraceptive methods starting from screening and until 12 months following the last infusion..

Exclusion criteria

• Any lymphoma other than CD20+ DLBCL
• History of indolent lymphoma
• DLBCL with central nervous system or meningeal involvement
• Primary gastrointestinal (MALT) lymphoma
• Bulky disease>10 cm diagnosed by imaging at screening
• Bone marrow involvement > 25% according to bone marrow biopsy at screening
• Subjects previously treated with chemotherapy, radiotherapy, immunotherapy or experimental therapies for lymphoma or other malignancy
• Hypersensitivity to active ingredients, excipients (sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections) and murine proteins
• Active uncontrolled infection (viral, bacterial or fungal infection) requiring systemic therapy at screening and/or at baseline visit.
• A documented history of recurrent or chronic clinically significant infection (viral, bacterial or fungal infection)
• Subjects with a history of tuberculosis or active tuberculosis at screening.
• Immunodeficiency syndrome or Human immunodeficiency virus (HIV) seropositivity
• Positive Hepatitis B surface antigen or antibodies to Hepatitis C
• History of other cancer within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of uterine cervix
• Any major surgical procedure within 12 weeks prior to screening and between screening and baseline
• Immunization with live viral vaccines less than 4 weeks prior to first study drug infusion, and/or planned live viral vaccination during study period.
• Known allergic reactions against foreign proteins
• Subjects for whom 8 cycles of CHOP might be problematic, and have the following findings/conditions, should not be enrolled:

• Cardiac contra-indication to doxorubicin: Left ventricular ejection fraction (LVEF) < 50% according to multi-acquisition gated (MUGA) scan or 2D Echocardiogram at screening
• Neurologic contra-indication to vincristine: (e.g., peripheral neuropathy)
• Abnormal hepatic function at screening and/or baseline
• AST/ALT ≥ 3 x upper normal value (ULN) or ≥ 5 x ULN in the presence of DLBCL involvement of the liver
• Bilirubin ≥ 2 x ULN or ≥ 5 x ULN in the presence of DLBCL involvement of the liver
• Abnormal renal function at screening and/or baseline
• Serum creatinine ≥ 2 x ULN
• Abnormal bone marrow function at screening and/or baseline
• Platelets < 100x109/L
• Neutrophils < 1.5x109/L
• Hb < 9g/dL
• Any other serious active disease or co-morbid medical condition (according to the investigator's decision and information provided in the Investigator Brochure of TL011)
• Subjects who, according to the investigator, are likely to be non-compliant or uncooperative during the study.
• Pregnant or lactating women or women that intend to get pregnant during study or within 12 months following the last infusion.
• Treatment with any investigational drug within 90 days before planned first cycle of chemotherapy.