Status:
COMPLETED
A Double-blind, Randomized Controlled Study in CD20-positive Diffuse B Cell Non-Hodgkin's Lymphoma Subjects
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
DLBCL
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
This is a prospective international, multi-center, randomized, double-blind controlled study designed to assess and compare the pharmacokinetics, pharmacodynamics and the safety of MabThera® and TL011...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT01205737
Start Date
September 1 2010
End Date
September 1 2013
Last Update
October 22 2013
Active Locations (41)
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1
Teva Investigational Site 59005
Pleven, Bulgaria
2
Teva Investigational Site 59003
Plovdiv, Bulgaria
3
Teva Investigational Site 59001
Sofia, Bulgaria
4
Teva Investigational Site 59002
Sofia, Bulgaria