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| Sponsor: | Millennium Pharmaceuticals, Inc. |
|---|---|
| Information provided by (Responsible Party): | Millennium Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00931918 |
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 II |
| 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 |
| 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
|
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 meeting any of the following exclusion criteria are not to be enrolled in the study:
Exclusion Criteria:
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
| 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 11, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
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 |