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

Launched by TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. · Sep 17, 2010

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Eligibility criteria

• 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:
• • 1. Any lymphoma other than CD20+ DLBCL
• • 2. History of indolent lymphoma
• • 3. DLBCL with central nervous system or meningeal involvement
• • 4. Primary gastrointestinal (MALT) lymphoma
• • 5. Bulky disease\>10 cm diagnosed by imaging at screening
• • 6. Bone marrow involvement \> 25% according to bone marrow biopsy at screening
• • 7. Subjects previously treated with chemotherapy, radiotherapy, immunotherapy or experimental therapies for lymphoma or other malignancy
• • 8. Hypersensitivity to active ingredients, excipients (sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections) and murine proteins
• • 9. Active uncontrolled infection (viral, bacterial or fungal infection) requiring systemic therapy at screening and/or at baseline visit.
• • 10. A documented history of recurrent or chronic clinically significant infection (viral, bacterial or fungal infection)
• • 11. Subjects with a history of tuberculosis or active tuberculosis at screening.
• • 12. Immunodeficiency syndrome or Human immunodeficiency virus (HIV) seropositivity
• • 13. Positive Hepatitis B surface antigen or antibodies to Hepatitis C
• • 14. History of other cancer within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of uterine cervix
• • 15. Any major surgical procedure within 12 weeks prior to screening and between screening and baseline
• • 16. Immunization with live viral vaccines less than 4 weeks prior to first study drug infusion, and/or planned live viral vaccination during study period.
• • 17. Known allergic reactions against foreign proteins
• 18. 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
• • 19. 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)
• • 20. Subjects who, according to the investigator, are likely to be non-compliant or uncooperative during the study.
• • 21. Pregnant or lactating women or women that intend to get pregnant during study or within 12 months following the last infusion.
• • 22. Treatment with any investigational drug within 90 days before planned first cycle of chemotherapy.