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

Follicular Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00085696
• Other study ID #: M34103-061
• Status: Completed
• Phase: Phase 2
• First received: June 11, 2004
• Last updated: February 7, 2008
• Start date: May 2004

Study information

• Verified date: February 2008
• Source: Millennium Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• B-Cell Lymphoma
• Follicular Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Follicular
• Marginal Lymphoma

Intervention

Drug:
• VELCADE and rituximab

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States,