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
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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 |
- 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 ]
- 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 |
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| 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| 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: | January 23, 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 May 23, 2013