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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
676
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.
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).
Progression Free Survival
Progression free survival is defined as time from randomization to progressive disease or death due to any cause, whichever occurs first.
Time frame: Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months.
Overall Response Rate
Overall response rate is defined as Complete Response (CR) + Complete Response Unconfirmed (CRu) + Partial Response (PR) using International Working Group Criteria (IWGC) and Independent Radiographic Review results and clinical results. The IWGC CR requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms, and normalization of lactic dehydrogenase and bone marrow involvement. CRu requires more than 75% reduction in sum of product of nodes (SPD). PR requires moer than 50% reduction in SPD.
Time frame: Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months.
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East Alabama Medical Center
Opelika, Alabama, United States
Central Hematology Oncology Medical Group, Inc
Alhambra, California, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, United States
Providence Saint Joseph Medical Center
Burbank, California, United States
St. Jude Heritage Medical Group
Fullerton, California, United States
Wilshire Oncology Medical Group, Inc.
La Verne, California, United States
Pacific Shores Medical Group
Long Beach, California, United States
University of Southern California
Los Angeles, California, United States
University of California, Los Angeles
Los Angeles, California, United States
North Valley Hematology Oncology
Mission Hills, California, United States
...and 196 more locations