NCT01205737
Completed
Phase 1
A Phase Ib, Double Blind RCT to Evaluate and Compare the PK, PD and Safety of MabThera® With TL011, in Combination With CHOP, in Subjects With CD20+ DLBCL
Teva Branded Pharmaceutical Products R&D, Inc.41 sites in 10 countries186 target enrollmentSeptember 2010
ConditionsDLBCL
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- DLBCL
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Enrollment
- 186
- Locations
- 41
- Primary Endpoint
- AUC during a dosing interval for Rituximab
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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, in combination with CHOP in previously untreated patients with diffuse large B cell lymphoma.
Investigators
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
- •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)
Outcomes
Primary Outcomes
AUC during a dosing interval for Rituximab
Time Frame: 21 weeks
Secondary Outcomes
- PK and PD parameters(Throughout study)
Study Sites (41)
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