Status:
COMPLETED
Study to Assess the Effectiveness of RCHOP With or Without VELCADE in Previously Untreated Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma Patients
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Non-Germinal B-Cell-like (GCB) Diffuse Large B-cell Lymphoma (DLBCL)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a randomized, open-label, multi-center, phase 2 study of RCHOP with or without VELCADE in adult patients with previously untreated non-(Germinal B-Cell-like) GCB Diffuse Large B-cell Lymphoma ...
Detailed Description
The drug tested in this study is called bortezomib (VELCADE®). VELCADE® was tested in people who have Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma. This study looked at the efficacy o...
Eligibility Criteria
Inclusion
- Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- Patients with previously untreated DLBCL that has been sub classified as the non-GCB subtype.
- At least 1 measurable tumor mass.
- Availability of paraffin block with sufficient tumor tissue.
- No evidence of central nervous system lymphoma.
- Eastern Cooperative Oncology Group (ECOG) performance status of \< or equal to 2.
- Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse.
- Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse.
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
Exclusion
- Diagnosed or treated for a malignancy other than DLBCL within 2 years of first dose or evidence of active malignancy other than DLBCL.
- Peripheral neuropathy of Grade 2 or greater.
- Known history of human immunodeficiency virus (HIV) infection, unless receiving highly active antiretroviral therapy (HAART).
- Active infection requiring systemic therapy.
- Major surgery within 2 weeks before first dose.
- Patients with a left ventricular ejection fraction (LVEF) or less than 45%.
- Myocardial infarction with 6 months of enrollment or evidence of current uncontrolled cardiovascular conditions as described in the protocol.
- History of allergic reaction/ hypersensitivity attributable to boron, mannitol, polysorbate 80 or sodium citrate dehydrate, or anaphylaxis or immunoglobulin E (IgE)-mediated hypersensitivity to murine proteins or to any component of rituximab.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT00931918
Start Date
October 1 2009
End Date
August 1 2015
Last Update
January 11 2017
Active Locations (70)
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1
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211
2
Fountain Valley Regional Hospital
Fountain Valley, California, United States, 92708
3
St. Jude Heritage Healthcare
Fullerton, California, United States, 92835
4
Moores Cancer Center- UCSD
La Jolla, California, United States, 92093