A Phase 2 Study of VELCADE® (Bortezomib) With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma
Data Collection
Immune System Diseases+6
+ Immunoproliferative Disorders
+ Lymphatic Diseases
Treatment Study
Summary
Study start date: May 1, 2004
Actual date on which the first participant was enrolled.The purpose of this study is to evaluate the safety and effectiveness of VELCADE when given in combination with rituximab in patients with Relapsed or Refractory Indolent B-Cell Lymphoma. This study will investigate if treatment with VELCADE and rituximab increases the time it takes your lymphoma to get worse.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.66 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Male or female subject 18 years or older * Diagnosis of B-cell lymphoma (CD20+) of * follicular lymphoma (grades 1, 2, and 3) or * marginal zone lymphoma (extranodal, nodal, and splenic) * Documented relapse or progression following prior anti-neoplastic treatment. * At least 1 measurable lymph node mass that is \>1.5 cm. * No active CNS lymphoma * Voluntary consent Exclusion Criteria: * Previous treatment with VELCADE * Any anti-neoplastic or experimental therapy within 3 weeks before the first dose of study drug. * Any treatment with nitrosoureas within 6 weeks before the first dose of study drug. * Treatment with Zevalin™ or Bexxar® within 10 weeks before the first dose of study drug. * Rituximab, Campath® or other unconjugated therapeutic antibody within 4 weeks before the first dose of study drug. * Radiation therapy within 3 weeks before the first dose of study drug. * Major surgery within 2 weeks before the first dose of study drug. * Peripheral neuropathy or neuropathic pain * History of allergic reaction attributable to compounds containing boron or mannitol * Known anaphylaxis or hypersensitivity to any component of rituximab * Diagnosed or treated for a selected malignancies other than NHL within 5 years. * Active systemic infection requiring treatment * Female subjects must not be pregnant, breast-feeding, or become pregnant during the course of the study. * Male subjects who do not agree to use an acceptable method of contraception for the duration of the study * Any serious medical or psychiatric illness likely to interfere with participation in this clinical study * Concurrent treatment with another investigational agent. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 13 locations
Florida Cancer Specialists
Fort Myers, United StatesEmory University Cancer Institute, Winship Cancer Institute
Atlanta, United StatesGeorgia Cancer Specialists
Marietta, United States