A Phase 2 Study of VELCADE® (Bortezomib) With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma

Date de début de l'étude : 1 mai 2004

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.