Study of Brentuximab Vedotin Combined With RCHOP or RCHP in Front-line Treatment of Patients With Diffuse Large B-cell Lymphoma (DLBCL)
Public ClinicalTrials.gov record NCT01925612. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2 Study of Brentuximab Vedotin in Combination With Standard of Care Treatment (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone [RCHOP]) or RCHP (Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone) as Front-line Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study has 3 parts. The purpose of Part 1 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) (known as BV+RCHOP) in patients with DLBCL who have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive RCHOP together with 1 of 2 doses of brentuximab vedotin. Patients will be tested to see if there is a difference in side effects between the 2 groups. The purpose of Part 2 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) (known as BV+RCHP) in patients with CD30-positive DLBCL who have never been treated. Patients will be enrolled to receive RCHP together with 1.8mg/kg of brentuximab vedotin. The purpose of Part 3 of this study is to assess the safety and efficacy of BV+RCHP compared to standard RCHOP in patients with CD30-positive DLBCL that have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive either BV+RCHP or RCHOP. Patients will be tested to see if there is a difference in side effects between the 2 groups.
Study identification
- NCT ID
- NCT01925612
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 87 participants
Conditions and interventions
Conditions
Interventions
- brentuximab vedotin Drug
- rituximab Drug
- vincristine Drug
- cyclophosphamide Drug
- prednisone Drug
- doxorubicin Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2013 (Type not available)
- Primary completion
- May 1, 2017 (Actual)
- Completion
- May 1, 2017 (Actual)
- Last update posted
- Jun 21, 2018
2013 – 2017
United States locations
- U.S. sites
- 36
- U.S. states
- 22
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Oncology Associates, PC - HAL | Phoenix | Arizona | 85016 | — |
| Arizona Oncology Associates, PC - HOPE | Tucson | Arizona | 85710 | — |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | — |
| Comprehensive Blood and Cancer Center | Bakersfield | California | 93309 | — |
| City of Hope National Medical Center | Duarte | California | 91010-3000 | — |
| Sansum Clinic | Santa Barbara | California | 93105 | — |
| Stanford Cancer Center | Stanford | California | 94305 | — |
| Rocky Mountain Cancer Centers - Aurora | Aurora | Colorado | 80012 | — |
| Augusta University | Augusta | Georgia | 30912 | — |
| Cardinal Bernardin Cancer Center / Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Illinois Cancer Specialists / Advocate Lutheran General Hospital | Niles | Illinois | 60714 | — |
| Norton Cancer Institute | Louisville | Kentucky | 40202 | — |
| Johns Hopkins Medical Center | Baltimore | Maryland | 21231 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Billings Clinic Cancer Research | Billings | Montana | 59101 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | — |
| Summit Medical Group | Morristown | New Jersey | 07962 | — |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07754 | — |
| New York Oncology Hematology, P.C. | Albany | New York | 12206 | — |
| Mid Ohio Oncology/Hematology Inc | Columbus | Ohio | 43219 | — |
| Willamette Valley Cancer Institute and Research Center | Springfield | Oregon | 97477 | — |
| Northwest Cancer Specialists, P.C. | Tualatin | Oregon | 97062 | — |
| Saint Francis Hospital / Bon Secours | Greenville | South Carolina | 29601 | — |
| Tennessee Cancer Specialists | Knoxville | Tennessee | 37909 | — |
| Texas Oncology - Austin Midtown | Austin | Texas | 78705 | — |
| Texas Oncology - Baylor Sammons Cancer Center | Dallas | Texas | 75246 | — |
| US Oncology Investigational Products Center (IPC) | Fort Worth | Texas | 76177 | — |
| MD Anderson Cancer Center / University of Texas | Houston | Texas | 77030-4095 | — |
| Texas Oncology - San Antonio Medical Center | San Antonio | Texas | 78229 | — |
| US Oncology Central Regulatory | The Woodlands | Texas | 77380 | — |
| Texas Oncology - Tyler | Tyler | Texas | 75702 | — |
| University of Utah | Salt Lake City | Utah | 84112 | — |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | — |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298 | — |
| Benaroya Research Institute/Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 15 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01925612, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 21, 2018 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01925612 live on ClinicalTrials.gov.