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

NCT01205737 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2013-10-22

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

TL011

375 mg/m2 iv every 3 weeks for 8 cycles

BIOLOGICAL

Rituximab

375 mg/m2 iv every 3 weeks for 8 cycles

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Mariano Provencio, MD, PhD · Hospital Universitario Puerta de Hierro

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-07-31
Completion
2013-09-30

Countries

  • Bulgaria
  • Estonia
  • France
  • Hungary
  • Italy
  • Latvia
  • Poland
  • Russia
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01205737 on ClinicalTrials.gov