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Study of VELCADE and Rituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

NCT00312845 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 676

Last updated 2012-06-25

Study results available
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Summary

The purpose of this study is to determine if the combination of VELCADE and rituximab improves progression free survival relative to rituximab alone in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (B-NHL) who never received rituximab or who have previously responded to rituximab. This is an international study being conducted in the United States and in many countries around the world. A complete list of study locations is listed below.

Conditions

  • Non-Hodgkin's Lymphoma

Interventions

DRUG

Bortezomib + Rituximab

VELCADE for Injection will be administered weekly on Days 1,8,15, and 22 of a 35-day cycle in combination with 4 doses of rituximab once a week on Days 1,8,15, and 22 of Cycle 1 and in combination with a single dose of rituximab on Day 1 of Cycles 2 to 5.

DRUG

Rituximab

rituximab once a week on Days 1,8,15, and 22 of Cycle 1, and as a single dose on Day 1 of Cycles 2 to 5 (for a total of 8 doses).

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    collaborator INDUSTRY

  • Millennium Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Millennium Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2010-06-30
Completion
2010-07-31

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • Cyprus
  • Czechia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • India
  • Israel
  • Italy
  • Mexico
  • New Zealand
  • Poland
  • Portugal
  • Puerto Rico
  • Romania
  • Russia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Thailand
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT00312845 on ClinicalTrials.gov