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Completed

NCT Number: NCT00085696

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

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.

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Key information

Conditions

B-cell Lymphoma Follicular Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Marginal Lymphoma Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UCLA School of Medicine, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VELCADE and rituximab

Drug

Sponsors and collaborators

Lead sponsor

Millennium Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
First posted
Jun 15, 2004
Registry last updated
Feb 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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