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
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
3 other identifiers
interventional
289
1 country
227
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 lymphoma
Started Feb 2011
Typical duration for phase_2 lymphoma
227 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2010
CompletedFirst Posted
Study publicly available on registry
October 7, 2010
CompletedStudy Start
First participant enrolled
February 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 2, 2019
CompletedResults Posted
Study results publicly available
February 23, 2021
CompletedJune 29, 2023
June 1, 2023
8.8 years
October 6, 2010
December 21, 2020
June 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Complete Remission (CR) Rate
Complete remission is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy. This analysis was conducted among 222 evaluable patients for the primary analysis. The purpose of this analysis is to compare the complete remission rate of rituximab + bendamustine vs. bortezomib + rituximab + bendamustine as induction therapy, therefore, the proportion of patients with complete remission was compared between Arm B (bortezomib + rituximab + bendamustine) and Arms A and C combined (rituximab + bendamustine).
Assessed every 4 weeks during induction treatment and every 8 weeks during continuation treatment, up to 2 years
1-year Post-induction Disease-free Survival (DFS) Rate
1-year post induction disease-free survival rate is defined as the proportion of patients achieving complete remission during induction treatment and are alive and maintaining complete remission at 1 year after induction completion. The purpose of this analysis is to compare the 1-year post-induction disease-free survival (DFS) rate with rituximab plus lenalidomide to rituximab alone as continuation therapy following induction treatment of bendamustine+rituximab, therefore, patients with induction treatment of bendamustine + rituximab + bortezomib were not included in this analysis.
Assessed at 1 year post-induction, approximately 1.5 years
Secondary Outcomes (23)
3-year Progression-free Survival Rate
Assessed every cycle during treatment and every 6 months between 2 and 5 years from study entry
5-year Overall Survival Rate
Assessed every cycle during treatment and every 6 months between 2 and 5 years from study entry
Complete Remission (CR) Rate
Assessed every 4 weeks during induction treatment and every 8 weeks during continuation treatment, up to 2 years
1-year Disease-free Survival (DFS) Rate
Assessed at 1 year post-induction, approximately 1.5 years
Progression-free Survival
Assessed every cycle during treatment and every 6 months between 2 and 5 years from study entry
- +18 more secondary outcomes
Study Arms (3)
Arm A then Arm D (Induction with Bendamustine + Rituximab; Continuation with Rituximab)
EXPERIMENTALArm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Arm D (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Arm B then Arm E (Induction with Bendamustine + Rituximab + Bortezomib; Continuation with Rituximab)
EXPERIMENTALArm B (induction): Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Arm E (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab as in arm D.
Arm C then Arm F (Induction with Bendamustine+Rituximab; Continuation with Lenalidomide + Rituximab)
EXPERIMENTALArm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Arm F (continuation): Immediately after completing induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Given IV
Given IV
Given orally
Eligibility Criteria
You may qualify if:
- Histologically confirmed (biopsy-proven) diagnosis of follicular B-cell non-Hodgkin lymphoma with no evidence of transformation to large cell histology
- Patients having both diffuse and follicular architectural elements are eligible if the histology is predominantly follicular (i.e., ≥ 50% of the cross-sectional area) and there is no evidence of transformation to a large cell histology
- Diagnostic confirmation (i.e., core needle or excisional lymph node biopsy) required if the interval since tissue diagnosis of low-grade malignant lymphoma is \> 24 months
- Bone marrow biopsy alone not acceptable
- Stage II, III, or IV AND grade 1, 2, or 3a disease
- Must meet criteria for High Tumor Burden (higher risk) as defined by either the Groupe D'Etude des Lymphomes Follicularies (GELF) criteria OR the follicular lymphoma international prognostic index (FLIPI) as defined below:
- Patient must meet ≥ 1 of the following GELF criteria:
- Nodal or extranodal mass ≥ 7 cm
- At least 3 nodal masses \> 3.0 cm in diameter
- Systemic symptoms due to lymphoma or B symptoms
- Splenomegaly with spleen \> 16 cm by CT scan
- Evidence of compression syndrome (e.g., ureteral, orbital, gastrointestinal) or pleural or peritoneal serous effusion due to lymphoma (irrespective of cell content)
- Leukemic presentation (≥ 5.0 x 10\^9/L malignant circulating follicular cells)
- Cytopenias (polymorphonuclear leukocytes \< 1.0 X 10\^9/L, hemoglobin \< 10 g/dL, and/or platelets \< 100 x 10\^9/L)
- Patient must have a FLIPI-1 score of 3, 4, or 5 (1 point per criterion below):
- +25 more criteria
You may not qualify if:
- Prior chemotherapy, radiotherapy, or immunotherapy for lymphoma
- Prednisone or other corticosteroids used for non-lymphomatous conditions will not be considered as prior chemotherapy
- A prior/recent short course (\< 2 weeks) of steroids for symptom relief of lymphoma-related symptoms is allowed
- Recent history of malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for ≥ 2 years
- Pregnant or nursing
- Active, uncontrolled infections (afebrile for \> 48 hours off antibiotics)
- ≥ grade 2 neuropathy
- Myocardial infarction within the past 6 months
- NYHA class III-IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- Known hypersensitivity to boron or mannitol
- Chronic carriers of hepatitis B virus (HBV) with positive hepatitis surface antigen (HBsAg +)
- Patient must have improved their response or have had no interval change in their tumor measurements with restaging from Induction cycle 3 to 6 as determined at Cycle 6 restaging.
- Adequate organ function
- ECOG performance status 0-2
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ECOG-ACRIN Cancer Research Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (227)
Marin Cancer Care Inc
Greenbrae, California, 94904, United States
Salinas Valley Memorial
Salinas, California, 93901, United States
Stanford University Hospitals and Clinics
Stanford, California, 94305, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
Boulder Community Hospital
Boulder, Colorado, 80301, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
Exempla Saint Joseph Hospital
Denver, Colorado, 80218, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220, United States
Rose Medical Center
Denver, Colorado, 80220, United States
Colorado Cancer Research Program CCOP
Denver, Colorado, 80224-2522, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80907, United States
Comprehensive Cancer Care and Research Institute of Colorado LLC
Englewood, Colorado, 80113, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Mountain Blue Cancer Care Center
Golden, Colorado, 80401, United States
North Colorado Medical Center
Greeley, Colorado, 80631, United States
Rocky Mountain Cancer Centers-Greenwood Village
Greenwood Village, Colorado, 80111, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, 80228, United States
Saint Anthony Hospital
Lakewood, Colorado, 80228, United States
Littleton Adventist Hospital
Littleton, Colorado, 80122, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, 80124, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
Longmont United Hospital
Longmont, Colorado, 80501, United States
McKee Medical Center
Loveland, Colorado, 80539, United States
Parker Adventist Hospital
Parker, Colorado, 80138, United States
Rocky Mountain Cancer Centers-Parker
Parker, Colorado, 80138, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004, United States
North Suburban Medical Center
Thornton, Colorado, 80229, United States
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, 80033, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Georgia Regents University Medical Center
Augusta, Georgia, 30912, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Rush - Copley Medical Center
Aurora, Illinois, 60504, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61701, United States
Saint Joseph Medical Center
Bloomington, Illinois, 61701, United States
Graham Hospital Association
Canton, Illinois, 61520, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Memorial Hospital
Carthage, Illinois, 62321, United States
Centralia Oncology Clinic
Centralia, Illinois, 62801, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Carle on Vermilion
Danville, Illinois, 61832, United States
Cancer Care Center of Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Eureka Hospital
Eureka, Illinois, 61530, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
Illinois CancerCare Galesburg
Galesburg, Illinois, 61401, United States
Mason District Hospital
Havana, Illinois, 62644, United States
Hinsdale Hematology Oncology Associates Incorporated
Hinsdale, Illinois, 60521, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
North Shore Hematology Oncology
Libertyville, Illinois, 60048, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Mcdonough District Hospital
Macomb, Illinois, 61455, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
Illinois CancerCare-Monmouth
Monmouth, Illinois, 61462, United States
Illinois Cancer Specialists-Niles
Niles, Illinois, 60714, United States
Bromenn Regional Medical Center
Normal, Illinois, 61761, United States
Community Cancer Center Foundation
Normal, Illinois, 61761, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
Pekin Cancer Treatment Center
Pekin, Illinois, 61554, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61603, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Illinois Oncology Research Association CCOP
Peoria, Illinois, 61615, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Illinois Valley Hospital
Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
SwedishAmerican Regional Cancer Center/ACT
Rockford, Illinois, 61107, United States
Memorial Medical Center
Springfield, Illinois, 62781-0001, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
The Carle Foundation Hospital
Urbana, Illinois, 61801, United States
IU Health Arnett Cancer Care
Lafayette, Indiana, 47904, United States
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, 46360, United States
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, 50010, United States
Ottumwa Regional Health Center
Ottumwa, Iowa, 52501, United States
Siouxland Hematology Oncology Associates
Sioux City, Iowa, 51101, United States
Mercy Medical Center-Sioux City
Sioux City, Iowa, 51104, United States
Saint Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Wesley Medical Center
Wichita, Kansas, 67214, United States
Ochsner Health Center-Summa
Baton Rouge, Louisiana, 70809, United States
Ochsner Baptist Medical Center
New Orleans, Louisiana, 70115, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Dana-Farber Harvard Cancer Center
Boston, Massachusetts, 02115, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106-0995, United States
Saint John Hospital and Medical Center
Detroit, Michigan, 48236, United States
Green Bay Oncology - Escanaba
Escanaba, Michigan, 49431, United States
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, 49801, United States
Allegiance Health
Jackson, Michigan, 49201, United States
Borgess Medical Center
Kalamazoo, Michigan, 49001, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
Saint Mary's of Michigan
Saginaw, Michigan, 48601, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, 56601, United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805, United States
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805, United States
Miller-Dwan Hospital
Duluth, Minnesota, 55805, United States
Fairview-Southdale Hospital
Edina, Minnesota, 55435, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, 07018-1095, United States
Hunterdon Medical Center
Flemington, New Jersey, 08822, United States
Cancer Institute of New Jersey At Hamilton
Hamilton, New Jersey, 08690, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
UMDNJ - New Jersey Medical School
Newark, New Jersey, 07103, United States
New York University Langone Medical Center
New York, New York, 10016, United States
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103, United States
Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Sanford Clinic North-Fargo
Fargo, North Dakota, 58122, United States
Sanford Medical Center-Fargo
Fargo, North Dakota, 58122, United States
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, 44304, United States
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, 43402, United States
Mercy Medical Center
Canton, Ohio, 44708, United States
Geaugra Hospital
Chardon, Ohio, 44024, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ireland Cancer Center Landerbrook Health Center
Mayfield Heights, Ohio, 44124, United States
Lake University Ireland Cancer Center
Mentor, Ohio, 44060, United States
Southwest General Health Center Ireland Cancer Center
Middleburg Heights, Ohio, 44130, United States
UHHS-Chagrin Highlands Medical Center
Orange, Ohio, 44122, United States
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, 43616, United States
Ireland Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio, 44870, United States
Flower Hospital
Sylvania, Ohio, 43560, United States
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, 43617, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, 43623, United States
University Hospitals Sharon Health Center
Wadsworth, Ohio, 44281, United States
UH-Seidman Cancer Center at Saint John Medical Center
Westlake, Ohio, 44145, United States
UHHS-Westlake Medical Center
Westlake, Ohio, 44145, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Geisinger Medical Oncology at Evangelical Community Hospital
Lewisburg, Pennsylvania, 17837, United States
Lewistown Hospital
Lewistown, Pennsylvania, 17044, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Aria Health-Torresdale Campus
Philadelphia, Pennsylvania, 19114, United States
Geisinger Medical Oncology-Pottsville
Pottsville, Pennsylvania, 17901, United States
Hematology and Oncology Associates of North East Pennsylvania
Scranton, Pennsylvania, 18508, United States
Geisinger Medical Group
State College, Pennsylvania, 16801, United States
Mount Nittany Medical Center
State College, Pennsylvania, 16803, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, 18711, United States
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Vanderbilt-Ingram Cancer Center Cool Springs
Franklin, Tennessee, 37067, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Parkland Memorial Hospital
Dallas, Texas, 75235, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
West Virginia University Charleston
Charleston, West Virginia, 25304, United States
West Virginia University Healthcare
Morgantown, West Virginia, 26506, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409, United States
Fox Valley Hematology and Oncology
Appleton, Wisconsin, 54911, United States
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729, United States
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, 54701, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, 54301-3526, United States
Bellin Memorial Hospital
Green Bay, Wisconsin, 54301, United States
Saint Vincent Hospital
Green Bay, Wisconsin, 54301, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, 54303, United States
Saint Mary's Hospital
Green Bay, Wisconsin, 54303, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311-6519, United States
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin, 53038, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
Dean Hematology and Oncology Clinic
Madison, Wisconsin, 53717, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Vince Lombardi Cancer Clinic-Marinette
Marinette, Wisconsin, 54143, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Saint Joseph's Hospital
Marshfield, Wisconsin, 54449, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548, United States
Oconomowoc Memorial Hospital-ProHealth Care Inc
Oconomowoc, Wisconsin, 53066-3896, United States
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904, United States
Marshfield Clinic at James Beck Cancer Center
Rhinelander, Wisconsin, 54501, United States
Saint Mary's Hospital
Rhinelander, Wisconsin, 54501, United States
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, 54868, United States
Saint Nicholas Hospital
Sheboygan, Wisconsin, 53081, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081, United States
Marshfield Clinic Cancer Care at Saint Michael's Hospital
Stevens Point, Wisconsin, 54481, United States
Saint Michael's Hospital
Stevens Point, Wisconsin, 54481, United States
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235, United States
Aurora Medical Center in Summit
Summit, Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic
Two Rivers, Wisconsin, 54241, United States
Waukesha Memorial Hospital - ProHealth Care
Waukesha, Wisconsin, 53188, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226, United States
Diagnostic and Treatment Center
Weston, Wisconsin, 54476, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, 54476, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494, United States
Riverview Hospital
Wisconsin Rapids, Wisconsin, 54494, United States
Related Publications (1)
Evens AM, Hong F, Habermann TM, Advani RH, Gascoyne RD, Witzig TE, Quon A, Ranheim EA, Ansell SM, Cheema PS, Dy PA, O'Brien TE, Winter JN, Cescon TP, Chang JE, Kahl BS. A Three-Arm Randomized Phase II Study of Bendamustine/Rituximab with Bortezomib Induction or Lenalidomide Continuation in Untreated Follicular Lymphoma: ECOG-ACRIN E2408. Clin Cancer Res. 2020 Sep 1;26(17):4468-4477. doi: 10.1158/1078-0432.CCR-20-1345. Epub 2020 Jun 12.
PMID: 32532790RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- ECOG-ACRIN Biostatistics Center
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew M. Evens, DO, MS
Robert H. Lurie Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2010
First Posted
October 7, 2010
Study Start
February 9, 2011
Primary Completion
December 2, 2019
Study Completion
December 2, 2019
Last Updated
June 29, 2023
Results First Posted
February 23, 2021
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.