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NCT00931918 · ClinicalTrials.gov registry record · 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
A Phase 2 study of Non-Germinal B-Cell-like (GCB) Diffuse Large B-cell Lymphoma (DLBCL), sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 206
- Enrollment target
- 20
- Study locations
NCT00931918: Completed Phase 2 study of Non-Germinal B-Cell-like (GCB) Diffuse Large B-cell Lymphoma (DLBCL), sponsored by Millennium Pharmaceuticals.
NCT00931918 is a Phase 2 study of Non-Germinal B-Cell-like (GCB) Diffuse Large B-cell Lymphoma (DLBCL) that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 206 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00931918, a Phase 2 study of Non-Germinal B-Cell-like (GCB) Diffuse Large B-cell Lymphoma (DLBCL), has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 206 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall respo
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Rituximab
- DRUG Vincristine
- DRUG Bortezomib
Study Locations (20)
California
- Tower Cancer Research Foundation - Beverly Hills
- Fountain Valley Regional Hospital - Fountain Valley
- St. Jude Heritage Healthcare - Fullerton
- Moores Cancer Center- UCSD - La Jolla
- Antelope Valley Cancer Center - Lancaster
- Loma Linda University Cancer Center - Loma Linda
- University of Southern California - Los Angeles
- Jonsson Comprehensive Cancer Center - Los Angeles
- TORI- Central Pharmacy - Los Angeles
- TORI- Central Regulatory - Los Angeles
- Oncology Care Medical Associates - Montebello
- Bay Area Cancer Research Group - Pleasant Hill
- Wilshire Oncology Medical Group - Rancho Cucamonga
- Sharp Healthcare - San Diego
- Central Coast Medical Oncology Corporation - Santa Maria
Florida
- Florida Cancer Specialists - Fort Myers
- Florida Cancer Specialists & Research Institute - Gainsville
- Alves/ Domenech Oncology-Hematology Clinic - Hollywood
- Florida Cancer Institute ATI - New Port Richey
Colorado
- Rocky Mountain Cancer Center - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2009-10 |
| Est. Completion | 2015-08 |
| Phase | Phase 2 |
What the finished NCT00931918 record still lists
NCT00931918 is an interventional study that assigns participants to a tested intervention. The registered 206 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% higher).
The record links to 1 condition, with Non-Germinal B-Cell-like (GCB) Diffuse Large B-cell Lymphoma (DLBCL) appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00931918 names 20 study sites across 3 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT00931918 about?
NCT00931918 is a clinical study titled "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 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...
What is the current status of trial NCT00931918?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 206 participants. The study started on 2009-10. Estimated completion is 2015-08.
What conditions does trial NCT00931918 study?
This clinical trial studies the following conditions: Non-Germinal B-Cell-like (GCB) Diffuse Large B-cell Lymphoma (DLBCL).
What interventions are being tested in trial NCT00931918?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Rituximab (DRUG), Vincristine (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT00931918?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00931918 being conducted?
This trial has 20 study locations across California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00931918's enrollment target sits among peer trials
206 298th of 2000 higher than 1,703 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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