VELCADE® (Bortezomib) With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Millennium Pharmaceuticals, Inc.
• Treatments: Bortezomib; Rituximab

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.