Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT00931918
Status:
COMPLETED
Last Update Posted:
2017-01-11
First Post:
2009-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
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
Sponsor:
Millennium Pharmaceuticals, Inc.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
The drug tested in this study is called bortezomib (VELCADE®). VELCADE® was tested in people who have Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma. This study looked at the efficacy of RCHOP \[rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone\] with or without VELCADE®.
The study enrolled 206 patients. Participants were enrolled in one of the two open label treatment groups:
* RCHOP
* Vc-RCHOP \[bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone\]
Participants received treatment for up to six, 21-day cycles.
This multi-center trial was conducted in the United States. The overall time to participate in this study was up to 48 months. Participants made multiple visits to the clinic, and were followed for progression free survival and overall survival until patient withdrawal, death, or 2 years after the last participant was enrolled.
The study enrolled 206 patients. Participants were enrolled in one of the two open label treatment groups:
* RCHOP
* Vc-RCHOP \[bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone\]
Participants received treatment for up to six, 21-day cycles.
This multi-center trial was conducted in the United States. The overall time to participate in this study was up to 48 months. Participants made multiple visits to the clinic, and were followed for progression free survival and overall survival until patient withdrawal, death, or 2 years after the last participant was enrolled.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1183-0186 | REGISTRY | WHO | View |