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

Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Study ID
NCT01205737
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • TL011 — BIOLOGICAL
    375 mg/m2 iv every 3 weeks for 8 cycles
  • Rituximab — BIOLOGICAL
    375 mg/m2 iv every 3 weeks for 8 cycles

Study Details

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.

Key Dates

Start date
Sep 30, 2010
Status verified
Oct 2013
Primary completion
Jul 31, 2013
Completion
Sep 30, 2013

Study Design

Enrollment
186 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TL011
  • Active Comparator: MabThera®

Primary Outcome Measure

AUC during a dosing interval for Rituximab [ Time Frame: 21 weeks ]

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