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 study is currently recruiting participants.
Verified July 2012 by Millennium Pharmaceuticals, Inc.

First Received on July 1, 2009.  
Last Updated on July 18, 2012  
History of Changes
This Clinical Trial Sponsored By: Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party): Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00931918
 

Purpose for Clinical Trial

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.

Condition Study Intervention Clinical Trial Phase
Non-Germinal B-Cell-like (GCB) Diffuse Large B-cell Lymphoma (DLBCL) Drug: Vc-RCHOP
Drug: RCHOP
Phase 2

Study Type: Study Interventional
Study Design: Allocation: Randomized
Study Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics:
Lymphoma
Drug Information available for:
Cyclophosphamide
Bortezomib

U.S. FDA Resources

Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures For Clinical Trial:

  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures For Clinical Trial:

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

Estimated Enrollment: 190
Study Start Date: October 2009
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Active Comparator: RCHOP

(rituximab, cyclophosphamide, doxorubicin, prednisone)
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.
Experimental: Vc-RCHOP

(VELCADE, rituximab, cyclophosphamide, doxorubicin, prednisone)
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.
Other Name: VELCADE

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00931918

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

 
Show 70 Study Locations

Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Inv

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