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

Official Title: “An Open-Label, Randomized, Phase 2 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”

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.

This study will be recruiting patients in Utah, Texas, Florida, Illinois, New Jersey and Michigan. Please call 1-866-835-2233 for more information.

Intervention(s) in this Clinical Trial

• Drug: Vc-RCHOP
  • bortezomib administered intravenously on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab intravenously, cyclophosphamide intravenously, doxorubicin intravenously and vincristine intravenously on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
• Drug: RCHOP
  • RCHOP administered as follows: rituximab intravenously, cyclophosphamide intravenously, doxorubicin intravenously and vincristine intravenously on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: RCHOP
  • (rituximab, cyclophosphamide, doxorubicin, prednisone)
• Experimental: Vc-RCHOP
  • (VELCADE, rituximab, cyclophosphamide, doxorubicin, prednisone)

Primary Measures

• To determine whether the addition of VELCADE to RCHOP improves progression-free survival (PFS) in patients with non-germinal center B-cell-like (non-GCB) diffuse large B-cell lymphoma (DLBCL).
  • Time Frame: 48 months
    Safety Issue?: No

Secondary Measures

• Overall Survival
  • Time Frame: 48 months
    Safety Issue?: No
• Overall Response Rate, Complete Response Rate and Duration of Response
  • Time Frame: 48 months
    Safety Issue?: No
• Fluorodeoxyglucose positron emission tomography (FDG-PET) negative rate
  • Time Frame: 48 months
    Safety Issue?: No
• Time to Progression
  • Time Frame: 48 months
    Safety Issue?: No
• Safety of the drug combination of VELCADE with RCHOP (Vc-RCHOP)
  • Time Frame: 48 months
    Safety Issue?: Yes

• Each patient must meet all of the following inclusion criteria to be enrolled in the study:

Inclusion Criteria:

• 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 Criteria:

• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Millennium Pharmaceuticals, Inc. Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Millennium Pharmaceuticals, Inc.  

Overall Contact: For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center 1-866-835-2233 medical@mlnm.com

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00931918

Study ID Number: C05013

ClinicalTrials.gov Identifier: NCT00931918

Health Authority: United States: Food and Drug Administration