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

Sponsor

Millennium Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00085696

Collaborator

(none)

Enrollment

Locations

5.1

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
B-Cell Lymphoma Follicular Lymphoma Marginal Lymphoma	Drug: VELCADE and rituximab	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2004

Actual Primary Completion Date :

Apr 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA School of Medicine	Los Angeles	California	United States	90095
2	Florida Cancer Specialists	Fort Myers	Florida	United States	33901
3	Emory University Cancer Institute, Winship Cancer Institute	Atlanta	Georgia	United States	30322
4	Georgia Cancer Specialists	Marietta	Georgia	United States	30060
5	Rush University Medical Center	Chicago	Illinois	United States	60612
6	Midwest Cancer Research Group	Skokie	Illinois	United States	60077
7	Cancer Center of Kansas	Wichita	Kansas	United States	67214
8	Oncology/Henmatology Associates of Kansas City	Kansas City	Missouri	United States	64111
9	Mid Ohio Oncology/Hematology Inc.	Columbus	Ohio	United States	43213
10	Charleston Cancer Center	Charleston	South Carolina	United States	29406
11	MD Anderson Cancer Center	Houston	Texas	United States	77030
12	University of Utah, Huntsman Cancer Institute	Salt Lake City	Utah	United States	84112
13	FNVHO - US Oncology	Fairfax	Virginia	United States	20031