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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00931918
First received: July 1, 2009
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
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:


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

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 70 Study Locations
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00931918     History of Changes
Other Study ID Numbers: C05013
Study First Received: July 1, 2009
Last Updated: July 24, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
Bortezomib
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 28, 2014