ClinicalTrials.gov record
Bendamustine Hydrochloride and Rituximab With or Without Bortezomib Followed by Rituximab With or Without Lenalidomide in Treating Patients With High-Risk Stage II, Stage III, or Stage IV Follicular Lymphoma
ClinicalTrials.gov ID: NCT01216683
Public ClinicalTrials.gov record NCT01216683. 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 3-Arm Randomized Phase II Trial of Bendamustine-Rituximab (BR) Followed by Rituximab vs Bortezomib-BR (BVR) Followed by Rituximab vs BR Followed by Lenalidomide/Rituximab in High Risk Follicular Lymphoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether giving bendamustine hydrochloride and rituximab together alone is more effective than giving bendamustine hydrochloride and rituximab together with bortezomib or lenalidomide in treating follicular lymphoma. PURPOSE: This randomized phase II trial is studying giving bendamustine hydrochloride and rituximab together with or without bortezomib followed by rituximab with or without lenalidomide to see how well they work in treating patients with high-risk stage II, stage III, or stage IV follicular lymphoma.
Study identification
- NCT ID
- NCT01216683
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 289 participants
Conditions and interventions
Conditions
Interventions
- rituximab Biological
- Bendamustin Drug
- bortezomib Drug
- lenalidomide Drug
Biological · 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
- Feb 9, 2011 (Actual)
- Primary completion
- Dec 2, 2019 (Actual)
- Completion
- Dec 2, 2019 (Actual)
- Last update posted
- Jun 29, 2023
2011 – 2019
United States locations
- U.S. sites
- 227
- U.S. states
- 25
- U.S. cities
- 161
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Marin Cancer Care Inc | Greenbrae | California | 94904 | — |
| Salinas Valley Memorial | Salinas | California | 93901 | — |
| Stanford University Hospitals and Clinics | Stanford | California | 94305 | — |
| The Medical Center of Aurora | Aurora | Colorado | 80012 | — |
| Boulder Community Hospital | Boulder | Colorado | 80301 | — |
| Rocky Mountain Cancer Centers-Boulder | Boulder | Colorado | 80304 | — |
| Penrose-Saint Francis Healthcare | Colorado Springs | Colorado | 80907 | — |
| Porter Adventist Hospital | Denver | Colorado | 80210 | — |
| Exempla Saint Joseph Hospital | Denver | Colorado | 80218 | — |
| Presbyterian - Saint Lukes Medical Center - Health One | Denver | Colorado | 80218 | — |
| Rocky Mountain Cancer Centers-Midtown | Denver | Colorado | 80218 | — |
| Rocky Mountain Cancer Centers-Rose | Denver | Colorado | 80220 | — |
| Rose Medical Center | Denver | Colorado | 80220 | — |
| Colorado Cancer Research Program CCOP | Denver | Colorado | 80224-2522 | — |
| Colorado Blood Cancer Institute | Denver | Colorado | 80907 | — |
| Comprehensive Cancer Care and Research Institute of Colorado LLC | Englewood | Colorado | 80113 | — |
| Swedish Medical Center | Englewood | Colorado | 80113 | — |
| Poudre Valley Hospital | Fort Collins | Colorado | 80524 | — |
| Mountain Blue Cancer Care Center | Golden | Colorado | 80401 | — |
| North Colorado Medical Center | Greeley | Colorado | 80631 | — |
| Rocky Mountain Cancer Centers-Greenwood Village | Greenwood Village | Colorado | 80111 | — |
| Rocky Mountain Cancer Centers-Lakewood | Lakewood | Colorado | 80228 | — |
| Saint Anthony Hospital | Lakewood | Colorado | 80228 | — |
| Littleton Adventist Hospital | Littleton | Colorado | 80122 | — |
| Rocky Mountain Cancer Centers-Sky Ridge | Lone Tree | Colorado | 80124 | — |
| Sky Ridge Medical Center | Lone Tree | Colorado | 80124 | — |
| Longmont United Hospital | Longmont | Colorado | 80501 | — |
| McKee Medical Center | Loveland | Colorado | 80539 | — |
| Parker Adventist Hospital | Parker | Colorado | 80138 | — |
| Rocky Mountain Cancer Centers-Parker | Parker | Colorado | 80138 | — |
| Saint Mary Corwin Medical Center | Pueblo | Colorado | 81004 | — |
| North Suburban Medical Center | Thornton | Colorado | 80229 | — |
| Exempla Lutheran Medical Center | Wheat Ridge | Colorado | 80033 | — |
| Christiana Care Health System-Christiana Hospital | Newark | Delaware | 19718 | — |
| Emory University/Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| Georgia Regents University Medical Center | Augusta | Georgia | 30912 | — |
| Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho | 83706 | — |
| Rush - Copley Medical Center | Aurora | Illinois | 60504 | — |
| Illinois CancerCare-Bloomington | Bloomington | Illinois | 61701 | — |
| Saint Joseph Medical Center | Bloomington | Illinois | 61701 | — |
| Graham Hospital Association | Canton | Illinois | 61520 | — |
| Illinois CancerCare-Canton | Canton | Illinois | 61520 | — |
| Illinois CancerCare-Carthage | Carthage | Illinois | 62321 | — |
| Memorial Hospital | Carthage | Illinois | 62321 | — |
| Centralia Oncology Clinic | Centralia | Illinois | 62801 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Carle on Vermilion | Danville | Illinois | 61832 | — |
| Cancer Care Center of Decatur | Decatur | Illinois | 62526 | — |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | — |
| Carle Physician Group-Effingham | Effingham | Illinois | 62401 | — |
| Crossroads Cancer Center | Effingham | Illinois | 62401 | — |
| Eureka Hospital | Eureka | Illinois | 61530 | — |
| Illinois CancerCare-Eureka | Eureka | Illinois | 61530 | — |
| Illinois CancerCare Galesburg | Galesburg | Illinois | 61401 | — |
| Mason District Hospital | Havana | Illinois | 62644 | — |
| Hinsdale Hematology Oncology Associates Incorporated | Hinsdale | Illinois | 60521 | — |
| Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois | 61443 | — |
| North Shore Hematology Oncology | Libertyville | Illinois | 60048 | — |
| Illinois CancerCare-Macomb | Macomb | Illinois | 61455 | — |
| Mcdonough District Hospital | Macomb | Illinois | 61455 | — |
| Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois | 61938 | — |
| Illinois CancerCare-Monmouth | Monmouth | Illinois | 61462 | — |
| Illinois Cancer Specialists-Niles | Niles | Illinois | 60714 | — |
| Bromenn Regional Medical Center | Normal | Illinois | 61761 | — |
| Community Cancer Center Foundation | Normal | Illinois | 61761 | — |
| Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois | 61350 | — |
| Ottawa Regional Hospital and Healthcare Center | Ottawa | Illinois | 61350 | — |
| Illinois CancerCare-Pekin | Pekin | Illinois | 61554 | — |
| Pekin Cancer Treatment Center | Pekin | Illinois | 61554 | — |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61603 | — |
| Proctor Hospital | Peoria | Illinois | 61614 | — |
| Illinois CancerCare-Peoria | Peoria | Illinois | 61615 | — |
| Illinois Oncology Research Association CCOP | Peoria | Illinois | 61615 | — |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | — |
| Illinois CancerCare-Peru | Peru | Illinois | 61354 | — |
| Illinois Valley Hospital | Peru | Illinois | 61354 | — |
| Illinois CancerCare-Princeton | Princeton | Illinois | 61356 | — |
| Perry Memorial Hospital | Princeton | Illinois | 61356 | — |
| SwedishAmerican Regional Cancer Center/ACT | Rockford | Illinois | 61107 | — |
| Memorial Medical Center | Springfield | Illinois | 62781-0001 | — |
| Carle Cancer Center | Urbana | Illinois | 61801 | — |
| The Carle Foundation Hospital | Urbana | Illinois | 61801 | — |
| IU Health Arnett Cancer Care | Lafayette | Indiana | 47904 | — |
| Franciscan Saint Anthony Health-Michigan City | Michigan City | Indiana | 46360 | — |
| McFarland Clinic PC-William R Bliss Cancer Center | Ames | Iowa | 50010 | — |
| Ottumwa Regional Health Center | Ottumwa | Iowa | 52501 | — |
| Siouxland Hematology Oncology Associates | Sioux City | Iowa | 51101 | — |
| Mercy Medical Center-Sioux City | Sioux City | Iowa | 51104 | — |
| Saint Luke's Regional Medical Center | Sioux City | Iowa | 51104 | — |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | — |
| Wesley Medical Center | Wichita | Kansas | 67214 | — |
| Ochsner Health Center-Summa | Baton Rouge | Louisiana | 70809 | — |
| Ochsner Baptist Medical Center | New Orleans | Louisiana | 70115 | — |
| Ochsner Medical Center Jefferson | New Orleans | Louisiana | 70121 | — |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Dana-Farber Harvard Cancer Center | Boston | Massachusetts | 02115 | — |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | — |
| Saint Joseph Mercy Hospital | Ann Arbor | Michigan | 48106-0995 | — |
| Saint John Hospital and Medical Center | Detroit | Michigan | 48236 | — |
| Green Bay Oncology - Escanaba | Escanaba | Michigan | 49431 | — |
| Green Bay Oncology - Iron Mountain | Iron Mountain | Michigan | 49801 | — |
| Allegiance Health | Jackson | Michigan | 49201 | — |
| Borgess Medical Center | Kalamazoo | Michigan | 49001 | — |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | — |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | — |
| Saint Joseph Mercy Oakland | Pontiac | Michigan | 48341 | — |
| Saint Mary's of Michigan | Saginaw | Michigan | 48601 | — |
| Saint John Macomb-Oakland Hospital | Warren | Michigan | 48093 | — |
| Sanford Clinic North-Bemidgi | Bemidji | Minnesota | 56601 | — |
| Essentia Health Saint Joseph's Medical Center | Brainerd | Minnesota | 56401 | — |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | — |
| Mercy Hospital | Coon Rapids | Minnesota | 55433 | — |
| Essentia Health Cancer Center | Duluth | Minnesota | 55805 | — |
| Essentia Health Saint Mary's Medical Center | Duluth | Minnesota | 55805 | — |
| Miller-Dwan Hospital | Duluth | Minnesota | 55805 | — |
| Fairview-Southdale Hospital | Edina | Minnesota | 55435 | — |
| Unity Hospital | Fridley | Minnesota | 55432 | — |
| Hutchinson Area Health Care | Hutchinson | Minnesota | 55350 | — |
| Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota | 55109 | — |
| Saint John's Hospital - Healtheast | Maplewood | Minnesota | 55109 | — |
| Abbott-Northwestern Hospital | Minneapolis | Minnesota | 55407 | — |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | — |
| North Memorial Medical Health Center | Robbinsdale | Minnesota | 55422 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Metro-Minnesota CCOP | Saint Louis Park | Minnesota | 55416 | — |
| Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | 55416 | — |
| Regions Hospital | Saint Paul | Minnesota | 55101 | — |
| United Hospital | Saint Paul | Minnesota | 55102 | — |
| Saint Francis Regional Medical Center | Shakopee | Minnesota | 55379 | — |
| Lakeview Hospital | Stillwater | Minnesota | 55082 | — |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | — |
| Rice Memorial Hospital | Willmar | Minnesota | 56201 | — |
| Minnesota Oncology and Hematology PA-Woodbury | Woodbury | Minnesota | 55125 | — |
| Saint Francis Medical Center | Cape Girardeau | Missouri | 63703 | — |
| Veterans Adminstration New Jersey Health Care System | East Orange | New Jersey | 07018-1095 | — |
| Hunterdon Medical Center | Flemington | New Jersey | 08822 | — |
| Cancer Institute of New Jersey At Hamilton | Hamilton | New Jersey | 08690 | — |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | — |
| UMDNJ - New Jersey Medical School | Newark | New Jersey | 07103 | — |
| New York University Langone Medical Center | New York | New York | 10016 | — |
| Essentia Health Cancer Center-South University Clinic | Fargo | North Dakota | 58103 | — |
| Roger Maris Cancer Center | Fargo | North Dakota | 58122 | — |
| Sanford Clinic North-Fargo | Fargo | North Dakota | 58122 | — |
| Sanford Medical Center-Fargo | Fargo | North Dakota | 58122 | — |
| Summa Akron City Hospital/Cooper Cancer Center | Akron | Ohio | 44304 | — |
| Toledo Clinic Cancer Centers-Bowling Green | Bowling Green | Ohio | 43402 | — |
| Mercy Medical Center | Canton | Ohio | 44708 | — |
| Geaugra Hospital | Chardon | Ohio | 44024 | — |
| Case Western Reserve University | Cleveland | Ohio | 44106 | — |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Ireland Cancer Center Landerbrook Health Center | Mayfield Heights | Ohio | 44124 | — |
| Lake University Ireland Cancer Center | Mentor | Ohio | 44060 | — |
| Southwest General Health Center Ireland Cancer Center | Middleburg Heights | Ohio | 44130 | — |
| UHHS-Chagrin Highlands Medical Center | Orange | Ohio | 44122 | — |
| Toledo Clinic Cancer Centers-Oregon | Oregon | Ohio | 43616 | — |
| Ireland Cancer Center at Firelands Regional Medical Center | Sandusky | Ohio | 44870 | — |
| Flower Hospital | Sylvania | Ohio | 43560 | — |
| Toledo Community Hospital Oncology Program CCOP | Toledo | Ohio | 43617 | — |
| Toledo Clinic Cancer Centers-Toledo | Toledo | Ohio | 43623 | — |
| University Hospitals Sharon Health Center | Wadsworth | Ohio | 44281 | — |
| UH-Seidman Cancer Center at Saint John Medical Center | Westlake | Ohio | 44145 | — |
| UHHS-Westlake Medical Center | Westlake | Ohio | 44145 | — |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001 | — |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | — |
| Geisinger Medical Center-Cancer Center Hazleton | Hazleton | Pennsylvania | 18201 | — |
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | — |
| Geisinger Medical Oncology at Evangelical Community Hospital | Lewisburg | Pennsylvania | 17837 | — |
| Lewistown Hospital | Lewistown | Pennsylvania | 17044 | — |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19107 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| Aria Health-Torresdale Campus | Philadelphia | Pennsylvania | 19114 | — |
| Geisinger Medical Oncology-Pottsville | Pottsville | Pennsylvania | 17901 | — |
| Hematology and Oncology Associates of North East Pennsylvania | Scranton | Pennsylvania | 18508 | — |
| Geisinger Medical Group | State College | Pennsylvania | 16801 | — |
| Mount Nittany Medical Center | State College | Pennsylvania | 16803 | — |
| Reading Hospital | West Reading | Pennsylvania | 19611 | — |
| Geisinger Wyoming Valley | Wilkes-Barre | Pennsylvania | 18711 | — |
| Sanford Cancer Center-Oncology Clinic | Sioux Falls | South Dakota | 57104 | — |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | — |
| Vanderbilt-Ingram Cancer Center Cool Springs | Franklin | Tennessee | 37067 | — |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| Parkland Memorial Hospital | Dallas | Texas | 75235 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| West Virginia University Charleston | Charleston | West Virginia | 25304 | — |
| West Virginia University Healthcare | Morgantown | West Virginia | 26506 | — |
| Langlade Hospital and Cancer Center | Antigo | Wisconsin | 54409 | — |
| Fox Valley Hematology and Oncology | Appleton | Wisconsin | 54911 | — |
| Marshfield Clinic-Chippewa Center | Chippewa Falls | Wisconsin | 54729 | — |
| Marshfield Clinic Cancer Center at Sacred Heart | Eau Claire | Wisconsin | 54701 | — |
| Green Bay Oncology at Saint Vincent Hospital | Green Bay | Wisconsin | 54301-3526 | — |
| Bellin Memorial Hospital | Green Bay | Wisconsin | 54301 | — |
| Saint Vincent Hospital | Green Bay | Wisconsin | 54301 | — |
| Green Bay Oncology Limited at Saint Mary's Hospital | Green Bay | Wisconsin | 54303 | — |
| Saint Mary's Hospital | Green Bay | Wisconsin | 54303 | — |
| Aurora BayCare Medical Center | Green Bay | Wisconsin | 54311-6519 | — |
| UW Cancer Center Johnson Creek | Johnson Creek | Wisconsin | 53038 | — |
| Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | — |
| Dean Hematology and Oncology Clinic | Madison | Wisconsin | 53717 | — |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | — |
| Vince Lombardi Cancer Clinic-Marinette | Marinette | Wisconsin | 54143 | — |
| Marshfield Clinic | Marshfield | Wisconsin | 54449 | — |
| Saint Joseph's Hospital | Marshfield | Wisconsin | 54449 | — |
| Froedtert and the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
| Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin | 54548 | — |
| Oconomowoc Memorial Hospital-ProHealth Care Inc | Oconomowoc | Wisconsin | 53066-3896 | — |
| Green Bay Oncology - Oconto Falls | Oconto Falls | Wisconsin | 54154 | — |
| Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh | Wisconsin | 54904 | — |
| Marshfield Clinic at James Beck Cancer Center | Rhinelander | Wisconsin | 54501 | — |
| Saint Mary's Hospital | Rhinelander | Wisconsin | 54501 | — |
| Marshfield Clinic-Rice Lake Center | Rice Lake | Wisconsin | 54868 | — |
| Saint Nicholas Hospital | Sheboygan | Wisconsin | 53081 | — |
| Vince Lombardi Cancer Clinic-Sheboygan | Sheboygan | Wisconsin | 53081 | — |
| Marshfield Clinic Cancer Care at Saint Michael's Hospital | Stevens Point | Wisconsin | 54481 | — |
| Saint Michael's Hospital | Stevens Point | Wisconsin | 54481 | — |
| Green Bay Oncology - Sturgeon Bay | Sturgeon Bay | Wisconsin | 54235 | — |
| Aurora Medical Center in Summit | Summit | Wisconsin | 53066 | — |
| Vince Lombardi Cancer Clinic | Two Rivers | Wisconsin | 54241 | — |
| Waukesha Memorial Hospital - ProHealth Care | Waukesha | Wisconsin | 53188 | — |
| Aspirus Regional Cancer Center | Wausau | Wisconsin | 54401 | — |
| Aurora Cancer Care-Milwaukee West | Wauwatosa | Wisconsin | 53226 | — |
| Diagnostic and Treatment Center | Weston | Wisconsin | 54476 | — |
| Marshfield Clinic - Weston Center | Weston | Wisconsin | 54476 | — |
| Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin | 54494 | — |
| Riverview Hospital | Wisconsin Rapids | Wisconsin | 54494 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01216683, 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 29, 2023 · Synced Oct 26, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01216683 live on ClinicalTrials.gov.