Clinical trial NCT00085696: VELCADE® (Bortezomib) With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma
Official title: A Phase 2 Study of VELCADE® (Bortezomib) With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: B-Cell Lymphoma
Follicular Lymphoma
Marginal Lymphoma
Keywords: Lymphoma
Non-Hodgkin's
NHL
B-Cell
Indolent
Lead sponsor: Millennium Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2004-06-15
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

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