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

Completed · Phase 2

Conditions studied: Non-Germinal B-Cell-like (GCB) Diffuse Large B-cell Lymphoma (DLBCL)

In brief

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 (DLBCL). The study will determine whether the addition of VELCADE to RCHOP improves progression-free survival (PFS) in patients with non-GCB DLBCL.

Key facts

Study ID

NCT00931918

Run by

Millennium Pharmaceuticals, Inc.

People needed

206

Starts

2009-10-01

Expected to finish

2015-08-01

Last updated by the study team

2017-01-11

Who can join

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

You may qualify if…

• 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:

You may not qualify if…

• 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.

Where it is running

• Fountain Valley Regional Hospital — Fountain Valley, California, United States
• St. Jude Heritage Healthcare — Fullerton, California, United States
• Moores Cancer Center- UCSD — La Jolla, California, United States
• Antelope Valley Cancer Center — Lancaster, California, United States
• Loma Linda University Cancer Center — Loma Linda, California, United States
• University of Southern California — Los Angeles, California, United States
• Jonsson Comprehensive Cancer Center — Los Angeles, California, United States
• TORI- Central Pharmacy — Los Angeles, California, United States
• TORI- Central Regulatory — Los Angeles, California, United States
• Oncology Care Medical Associates — Montebello, California, United States
• Bay Area Cancer Research Group — Pleasant Hill, California, United States
• Wilshire Oncology Medical Group — Rancho Cucamonga, California, United States
• Sharp Healthcare — San Diego, California, United States
• Central Coast Medical Oncology Corporation — Santa Maria, California, United States
• Rocky Mountain Cancer Center — Denver, Colorado, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Florida Cancer Specialists & Research Institute — Gainsville, Florida, United States
• Alves/ Domenech Oncology-Hematology Clinic — Hollywood, Florida, United States
• Florida Cancer Institute ATI — New Port Richey, Florida, United States
• MD Anderson Cancer Center of Orlando — Orlando, Florida, United States
• Coastal Oncology, PL — Ormond Beach, Florida, United States
• Winship Cancer Institute at Emory University — Atlanta, Georgia, United States
• Georgia Cancer Specialists — Atlanta, Georgia, United States
• Dublin Hematology and Oncology — Dublin, Georgia, United States
• Tower Cancer Research Foundation — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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