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

Completed · Phase 2

Conditions studied: B-Cell Lymphoma, Follicular Lymphoma, Marginal Lymphoma

In brief

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.

Key facts

Study ID

NCT00085696

Run by

Millennium Pharmaceuticals, Inc.

People needed

66

Starts

2004-05-01

Last updated by the study team

2008-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• UCLA School of Medicine — Los Angeles, California, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Emory University Cancer Institute, Winship Cancer Institute — Atlanta, Georgia, United States
• Georgia Cancer Specialists — Marietta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Midwest Cancer Research Group — Skokie, Illinois, United States
• Cancer Center of Kansas — Wichita, Kansas, United States
• Oncology/Henmatology Associates of Kansas City — Kansas City, Missouri, United States
• Mid Ohio Oncology/Hematology Inc. — Columbus, Ohio, United States
• Charleston Cancer Center — Charleston, South Carolina, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• University of Utah, Huntsman Cancer Institute — Salt Lake City, Utah, United States
• FNVHO - US Oncology — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

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