Intergroup Randomized Phase 2 Four Arm Study In Patients ≥ 60 With Previously Untreated Mantle Cell Lymphoma Of Therapy With: Arm A = Rituximab+ Bendamustine Followed By Rituximab Consolidation (RB → R); Arm B = Rituximab + Bendamustine + Bortezomib Followed By Rituximab Consolidation (RBV→ R), Arm C = Rituximab + Bendamustine Followed By Lenalidomide + Rituximab Consolidation (RB → LR) or Arm D = Rituximab + Bendamustine + Bortezomib Followed By Lenalidomide + Rituximab Consolidation (RBV → LR)

Who is this study for? Patients with Mantle Cell Lymphoma
What treatments are being studied? Rituximab
Status: Active, not recruiting
Location: See all (418) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer cells or stop them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of mantle cell lymphoma by blocking blood flow to the cancer. It is not yet known whether giving rituximab together with bendamustine and bortezomib is more effective than rituximab and bendamustine, followed by rituximab alone or with lenalidomide in treating mantle cell lymphoma. PURPOSE: This randomized phase II trial studies rituximab, bortezomib, bendamustine, and lenalidomide in treating previously untreated older patients with mantle cell lymphoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 120
Healthy Volunteers: No
View:

• DISEASE CHARACTERISTICS:

• Histologically confirmed untreated mantle cell lymphoma (MCL), with documented cyclin D1 by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescence in situ hybridization (FISH)

• Patients must have at least one objective measurable disease parameter

• Abnormal PET scans will not constitute evaluable disease, unless verified by CT scan or other appropriate imaging

• Measurable disease in the liver is required if the liver is the only site of lymphoma

• Patient must have no CNS involvement

• PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• ANC ≥ 1,500/mcL (1.5 x 10^9/L)*

• Platelets ≥ 100,000/mcL (100 x 10^9/L)* NOTE: *Unless due to marrow involvement.

• AST/ALT ≤ 2 times upper limit of normal (ULN)

• Bilirubin ≤ 2 times ULN

• Calculated creatinine clearance by Cockroft-Gault formula ≥ 30 mL/min

• Women (sexually mature female) must not be pregnant or breast-feeding

• Negative pregnancy test

• Women of childbearing potential and sexually active males use an accepted and effective method of contraception

• Men must agree to use a latex condom during sexual contact with a female of child-bearing potential, even if they have had a successful vasectomy

• All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure

• No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma, or any surgically or radiation-cured malignancy continuously disease free for ≥ 5 years so as not to interfere with interpretation of radiographic response

• Patient agrees that if randomized to Arms C or D, and proceed onto Arms G or H, they must register into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®

• Patients must have no medical contra-indications to, and be willing to take, deep vein thrombosis (DVT) prophylaxis as all patients registering to the lenalidomide/rituximab Arms G and H will be required to have DVT prophylaxis

• Patients randomized to Arms G or H who have a history of a thrombotic vascular event will be required to have therapeutic doses of low-molecular weight heparin or warfarin to maintain an INR between 2.0 - 3.0

• Patients on Arms G and H without a history of a thromboembolic event are required to take a daily aspirin (81 mg or 325 mg) for DVT prophylaxis

• Patients who are unable to tolerate aspirin should receive low molecular weight heparin therapy or warfarin treatment

• Women must agree to abstain from donating blood during study participation and for at least 28 days after discontinuation from protocol treatment

• Males must agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation from protocol treatment

• HIV-positive patients are not excluded but, to enroll, must meet all of the below criteria:

• HIV is sensitive to antiretroviral therapy

• Must be willing to take effective antiretroviral therapy, if indicated

• No history of CD4 prior to or at the time of lymphoma diagnosis < 300 cells/mm³

• No history of AIDS-defining conditions

• If on antiretroviral therapy, must not be taking zidovudine or stavudine

• Must be willing to take prophylaxis for Pneumocystis jiroveci pneumonia (PCP) during therapy and until at least 2 months following the completion of therapy or until the CD4 cells recover to over 250 cells/mm³, whichever occurs later

• Patients must not have grade 2 or greater peripheral neuropathy

• Patients must not have NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia

• Patients must not have hypersensitivity to bortezomib, boron, or mannitol

• Patients must not have a serious medical or psychiatric illness likely to interfere with study participation

• PRIOR CONCURRENT THERAPY:

• No prior therapy for MCL, except < 1 week of steroid therapy for symptom control

• HIV-positive patients are not excluded, but to enroll, must meet all of the below criteria:

• Must be willing to take effective antiretroviral therapy if indicated

• If on antiretroviral therapy, must not be taking zidovudine or stavudine

• Patients must not be participating in any other clinical trial or taking any other experimental medications within 14 days prior to registration

Locations
United States
Alaska
Alaska Breast Care and Surgery LLC
Anchorage
Alaska Women's Cancer Care
Anchorage
Anchorage Oncology Centre
Anchorage
Katmai Oncology Group
Anchorage
Providence Alaska Medical Center
Anchorage
California
Kaiser Permanente-Deer Valley Medical Center
Antioch
Kaiser Permanente, Fremont
Fremont
Kaiser Permanente
Fresno
Los Angeles County-USC Medical Center
Los Angeles
USC / Norris Comprehensive Cancer Center
Los Angeles
Kaiser Permanente-Modesto
Modesto
Kaiser Permanente-Oakland
Oakland
Kaiser Permanente-Redwood City
Redwood City
Kaiser Permanente-Richmond
Richmond
Kaiser Permanente-Roseville
Roseville
Kaiser Permanente - Sacramento
Sacramento
Kaiser Permanente-South Sacramento
Sacramento
Kaiser Permanente-San Francisco
San Francisco
Kaiser Permanente-Santa Teresa-San Jose
San Jose
Kaiser Permanente San Leandro
San Leandro
Kaiser Permanente-San Rafael
San Rafael
Kaiser Permanente Medical Center - Santa Clara
Santa Clara
Kaiser Permanente-Santa Rosa
Santa Rosa
Kaiser Permanente-South San Francisco
South San Francisco
Stanford University Hospitals and Clinics
Stanford
Kaiser Permanente-Stockton
Stockton
Kaiser Permanente Medical Center-Vacaville
Vacaville
Kaiser Permanente-Vallejo
Vallejo
Kaiser Permanente-Walnut Creek
Walnut Creek
Colorado
Rocky Mountain Cancer Centers-Aurora
Aurora
The Medical Center of Aurora
Aurora
Boulder Community Hospital
Boulder
Rocky Mountain Cancer Centers-Boulder
Boulder
Penrose-Saint Francis Healthcare
Colorado Springs
Rocky Mountain Cancer Centers-Penrose
Colorado Springs
Colorado Blood Cancer Institute
Denver
Colorado Cancer Research Program CCOP
Denver
Exempla Saint Joseph Hospital
Denver
Kaiser Permanente-Franklin
Denver
Porter Adventist Hospital
Denver
Presbyterian - Saint Lukes Medical Center - Health One
Denver
Rocky Mountain Cancer Centers-Midtown
Denver
Rocky Mountain Cancer Centers-Rose
Denver
Rose Medical Center
Denver
Mercy Medical Center
Durango
Southwest Oncology PC
Durango
Comprehensive Cancer Care and Research Institute of Colorado LLC
Englewood
Swedish Medical Center
Englewood
Poudre Valley Hospital
Fort Collins
Mountain Blue Cancer Care Center
Golden
North Colorado Medical Center
Greeley
Rocky Mountain Cancer Centers-Greenwood Village
Greenwood Village
Kaiser Permanente-Rock Creek
Lafayette
Rocky Mountain Cancer Centers-Lakewood
Lakewood
Saint Anthony Hospital
Lakewood
Littleton Adventist Hospital
Littleton
Rocky Mountain Cancer Centers-Littleton
Littleton
Kaiser Permanente-Lone Tree
Lone Tree
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree
Sky Ridge Medical Center
Lone Tree
Longmont United Hospital
Longmont
Rocky Mountain Cancer Centers-Longmont
Longmont
McKee Medical Center
Loveland
Parker Adventist Hospital
Parker
Rocky Mountain Cancer Centers-Parker
Parker
Rocky Mountain Cancer Centers - Pueblo
Pueblo
Saint Mary Corwin Medical Center
Pueblo
Rocky Mountain Cancer Centers-Thornton
Thornton
Exempla Lutheran Medical Center
Wheat Ridge
Connecticut
Saint Francis Hospital and Medical Center
Hartford
Washington, D.c.
Lombardi Comprehensive Cancer Center at Georgetown University
Washington
Delaware
Beebe Medical Center
Lewes
Christiana Care Health System-Christiana Hospital
Newark
Christiana Gynecologic Oncology LLC
Newark
Delaware Clinical and Laboratory Physicians PA
Newark
Helen F Graham Cancer Center
Newark
Medical Oncology Hematology Consultants PA
Newark
Regional Hematology and Oncology PA
Newark
Beebe Health Campus
Rehoboth Beach
Nanticoke Memorial Hospital
Seaford
Christiana Care Health System-Wilmington Hospital
Wilmington
Florida
Baptist Cancer Institute
Jacksonville
UF Cancer Center at Orlando Health
Orlando
Hawaii
Oncare Hawaii Inc-Pali Momi
'aiea
Pali Momi Medical Center
'aiea
Kaiser Permanente Moanalua Medical Center
Honolulu
Kapiolani Medical Center for Women and Children
Honolulu
Oncare Hawaii Inc-Kuakini
Honolulu
Oncare Hawaii Inc-POB II
Honolulu
OnCare Hawaii-Liliha
Honolulu
Queen's Medical Center
Honolulu
Straub Clinic and Hospital
Honolulu
University of Hawaii Cancer Center
Honolulu
Castle Medical Center
Kailua
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue
Iowa
Mary Greeley Medical Center
Ames
McFarland Clinic PC-William R Bliss Cancer Center
Ames
Hematology Oncology Associates-Quad Cities
Bettendorf
McFarland Clinic PC-Boone
Boone
Cedar Rapids Oncology Association
Cedar Rapids
Mercy Hospital
Cedar Rapids
Oncology Associates at Mercy Medical Center
Cedar Rapids
McFarland Clinic PC-Trinity Cancer Center
Fort Dodge
McFarland Clinic PC-Jefferson
Jefferson
McFarland Clinic PC-Marshalltown
Marshalltown
Mercy Medical Center-Sioux City
Sioux City
Saint Luke's Regional Medical Center
Sioux City
Siouxland Hematology Oncology Associates
Sioux City
Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise
Idaho Urologic Institute-Meridian
Meridian
Kootenai Cancer Center
Post Falls
Kootenai Cancer
Sandpoint
Illinois
Memorial Hospital of Carbondale
Carbondale
Centralia Oncology Clinic
Centralia
Hematology and Oncology Associates
Chicago
John H Stroger Jr Hospital of Cook County
Chicago
Mount Sinai Hospital Medical Center
Chicago
Northwestern University
Chicago
Carle on Vermilion
Danville
Cancer Care Center of Decatur
Decatur
Decatur Memorial Hospital
Decatur
Carle Physician Group-Effingham
Effingham
Crossroads Cancer Center
Effingham
Hematology Oncology Associates of Illinois-Highland Park
Highland Park
Presence Saint Mary's Hospital
Kankakee
North Shore Hematology Oncology
Libertyville
Carle Physician Group-Mattoon/Charleston
Mattoon
Good Samaritan Regional Health Center
Mount Vernon
Illinois Cancer Specialists-Niles
Niles
SwedishAmerican Regional Cancer Center/ACT
Rockford
Hematology Oncology Associates of Illinois - Skokie
Skokie
Memorial Medical Center
Springfield
Carle Cancer Center
Urbana
The Carle Foundation Hospital
Urbana
Indiana
IU Health Arnett Cancer Care
Lafayette
Franciscan Saint Anthony Health-Michigan City
Michigan City
Woodland Cancer Care Center
Michigan City
Reid Hospital and Health Care Services
Richmond
Kansas
Lawrence Memorial Hospital
Lawrence
Menorah Medical Center
Overland Park
Saint Luke's South Hospital
Overland Park
Kansas City CCOP
Prairie Village
Wesley Medical Center
Wichita
Kentucky
Oncology Hematology Care Inc-Crestview
Crestview Hills
Louisiana
Ochsner Health Center-Summa
Baton Rouge
Ochsner Baptist Medical Center
New Orleans
Ochsner Medical Center Jefferson
New Orleans
Massachusetts
Tufts Medical Center
Boston
Simonds-Sinon Regional Cancer Center
Fitchburg
Baystate Medical Center
Springfield
University of Massachusetts Medical School
Worcester
Maryland
Franklin Square Hospital Center
Baltimore
Union Hospital of Cecil County
Elkton
Holy Cross Hospital
Silver Spring
Maine
Harold Alfond Center for Cancer Care
Augusta
Eastern Maine Medical Center
Bangor
Penobscot Bay Medical Center
Rockport
Michigan
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor
Saint Joseph Mercy Hospital
Ann Arbor
Bronson Battle Creek
Battle Creek
Spectrum Health Big Rapids Hospital
Big Rapids
Oakwood Hospital and Medical Center
Dearborn
Saint John Hospital and Medical Center
Detroit
Wayne State University/Karmanos Cancer Institute
Detroit
Green Bay Oncology - Escanaba
Escanaba
Weisberg Cancer Treatment Center
Farmington Hills
Genesys Hurley Cancer Institute
Flint
Hurley Medical Center
Flint
Genesys Regional Medical Center
Grand Blanc
Grand Rapids Clinical Oncology Program
Grand Rapids
Mercy Health Saint Mary's
Grand Rapids
Spectrum Health at Butterworth Campus
Grand Rapids
Green Bay Oncology - Iron Mountain
Iron Mountain
Allegiance Health
Jackson
Borgess Medical Center
Kalamazoo
Bronson Methodist Hospital
Kalamazoo
West Michigan Cancer Center
Kalamazoo
Sparrow Hospital
Lansing
Saint Mary Mercy Hospital
Livonia
Mercy Health Mercy Campus
Muskegon
Lakeland Community Hospital
Niles
Saint Joseph Mercy Oakland
Pontiac
Saint Joseph Mercy Port Huron
Port Huron
Spectrum Health Reed City Hospital
Reed City
Saint Mary's of Michigan
Saginaw
Lakeland Hospital
Saint Joseph
Marie Yeager Cancer Center
Saint Joseph
Munson Medical Center
Traverse City
Saint John Macomb-Oakland Hospital
Warren
Minnesota
Sanford Clinic North-Bemidgi
Bemidji
Fairview Ridges Hospital
Burnsville
Mercy Hospital
Coon Rapids
Essentia Health Cancer Center
Duluth
Essentia Health Saint Mary's Medical Center
Duluth
Miller-Dwan Hospital
Duluth
Fairview-Southdale Hospital
Edina
Unity Hospital
Fridley
Hutchinson Area Health Care
Hutchinson
Minnesota Oncology Hematology PA-Maplewood
Maplewood
Saint John's Hospital - Healtheast
Maplewood
Abbott-Northwestern Hospital
Minneapolis
Health Partners Inc
Minneapolis
Hennepin County Medical Center
Minneapolis
New Ulm Medical Center
New Ulm
North Memorial Medical Health Center
Robbinsdale
Mayo Clinic
Rochester
Metro-Minnesota CCOP
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park
Regions Hospital
Saint Paul
United Hospital
Saint Paul
Saint Francis Regional Medical Center
Shakopee
Lakeview Hospital
Stillwater
Ridgeview Medical Center
Waconia
Rice Memorial Hospital
Willmar
Minnesota Oncology and Hematology PA-Woodbury
Woodbury
Missouri
Parkland Health Center-Bonne Terre
Bonne Terre
Saint Francis Medical Center
Cape Girardeau
Southeast Cancer Center
Cape Girardeau
University of Missouri - Ellis Fischel
Columbia
Centerpoint Medical Center LLC
Independence
Capital Region Medical Center-Goldschmidt Cancer Center
Jefferson City
Freeman Health System
Joplin
Heartland Hematology and Oncology Associates Incorporated
Kansas City
Research Medical Center
Kansas City
Saint Luke's Hospital of Kansas City
Kansas City
Saint Luke's East - Lee's Summit
Lee's Summit
Liberty Radiation Oncology Center
Liberty
Phelps County Regional Medical Center
Rolla
Saint John's Clinic-Rolla-Cancer and Hematology
Rolla
Heartland Regional Medical Center
Saint Joseph
Comprehensive Cancer Care PC
Saint Louis
Missouri Baptist Medical Center
Saint Louis
Saint John's Mercy Medical Center
Saint Louis
Saint Louis Cancer and Breast Institute-South City
Saint Louis
Washington University School of Medicine
Saint Louis
CoxHealth South Hospital
Springfield
Mercy Hospital Springfield
Springfield
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
Springfield
Missouri Baptist Sullivan Hospital
Sullivan
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills
Montana
Billings Clinic Cancer Center
Billings
Frontier Cancer Center and Blood Institute-Billings
Billings
Montana Cancer Consortium CCOP
Billings
Saint Vincent Healthcare
Billings
Bozeman Deaconess Hospital
Bozeman
Saint James Community Hospital and Cancer Treatment Center
Butte
Benefis Healthcare- Sletten Cancer Institute
Great Falls
Great Falls Clinic
Great Falls
Northern Montana Hospital
Havre
Saint Peter's Community Hospital
Helena
Glacier Oncology PLLC
Kalispell
Kalispell Medical Oncology
Kalispell
Kalispell Regional Medical Center
Kalispell
Community Medical Hospital
Missoula
Montana Cancer Specialists
Missoula
Saint Patrick Hospital - Community Hospital
Missoula
North Carolina
Southeastern Medical Oncology Center-Clinton
Clinton
Southeastern Medical Oncology Center-Goldsboro
Goldsboro
Wayne Memorial Hospital
Goldsboro
Hendersonville Hematology and Oncology at Pardee
Hendersonville
Margaret R Pardee Memorial Hospital
Hendersonville
Park Ridge Hospital Breast Health Center
Hendersonville
Southeastern Medical Oncology Center-Jacksonville
Jacksonville
Kinston Medical Specialists PA
Kinston
Iredell Memorial Hospital
Statesville
Southeastern Medical Oncology Center-Wilson
Wilson
Wake Forest University Health Sciences
Winston-salem
North Dakota
Roger Maris Cancer Center
Fargo
Sanford Clinic North-Fargo
Fargo
Sanford Medical Center-Fargo
Fargo
New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon
Norris Cotton Cancer Center Nashua
Nashua
New Jersey
Cooper Hospital University Medical Center
Camden
Veterans Adminstration New Jersey Health Care System
East Orange
New York
Hematology Oncology Associates of Central New York-Auburn
Auburn
Albert Einstein College of Medicine
Bronx
Montefiore Medical Center - Moses Campus
Bronx
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse
Glens Falls Hospital
Glens Falls
Hematology Oncology Associates of Central New York-Liverpool
Liverpool
Orange Regional Medical Center
Middletown
Mount Sinai Medical Center
New York
Weill Medical College of Cornell University
New York
University of Rochester
Rochester
Hematology Oncology Associates of Central New York-Rome
Rome
Hematology Oncology Associates of Central New York-Onondaga Hill
Syracuse
Ohio
Summa Akron City Hospital/Cooper Cancer Center
Akron
Summa Barberton Hospital
Barberton
Cleveland Clinic Cancer Center Beachwood
Beachwood
Oncology and Hematology Care Inc-Taft
Cincinnati
Oncology Hematology Care Inc - Anderson
Cincinnati
Oncology Hematology Care Inc - Kenwood
Cincinnati
Oncology Hematology Care Inc-Blue Ash
Cincinnati
Oncology Hematology Care Inc-Mercy West
Cincinnati
University of Cincinnati
Cincinnati
Case Western Reserve University
Cleveland
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland
Cleveland Clinic Foundation
Cleveland
MetroHealth Medical Center
Cleveland
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus
Dayton CCOP
Dayton
Good Samaritan Hospital - Dayton
Dayton
Grandview Hospital
Dayton
Miami Valley Hospital
Dayton
Samaritan North Health Center
Dayton
Mercy Cancer Center-Elyria
Elyria
Oncology Hematology Care Inc-Healthplex
Fairfield
Blanchard Valley Hospital
Findlay
Atrium Medical Center-Middletown Regional Hospital
Franklin
Wayne Hospital
Greenville
Cleveland Clinic Cancer Center Independence
Independence
Kettering Medical Center
Kettering
Cleveland Clinic Cancer Center Mansfield
Mansfield
Hillcrest Hospital Cancer Center
Mayfield Heights
Lake University Ireland Cancer Center
Mentor
North Coast Cancer Care
Sandusky
Cleveland Clinic Cancer Center Strongsville
Strongsville
Upper Valley Medical Center
Troy
South Pointe Hospital
Warrensville Heights
University Pointe
West Chester
UH-Seidman Cancer Center at Saint John Medical Center
Westlake
Cleveland Clinic Wooster Specialty Center
Wooster
Greene Memorial Hospital
Xenia
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Tulsa Cancer Institute
Tulsa
Oregon
Clackamas Radiation Oncology Center
Clackamas
Providence Milwaukie Hospital
Milwaukie
Providence Newberg Medical Center
Newberg
Providence Willamette Falls Medical Center
Oregon City
Providence Portland Medical Center
Portland
Providence Saint Vincent Medical Center
Portland
Western Oncology Research Consortium
Portland
Pennsylvania
Geisinger Medical Center
Danville
Geisinger Medical Center-Cancer Center Hazleton
Hazleton
Geisinger Medical Oncology at Evangelical Community Hospital
Lewisburg
Lewistown Hospital
Lewistown
Fox Chase Cancer Center
Philadelphia
Pottstown Memorial Medical Center
Pottstown
Geisinger Medical Oncology-Pottsville
Pottsville
Geisinger Medical Group
State College
Mount Nittany Medical Center
State College
Reading Hospital
West Reading
Geisinger Wyoming Valley
Wilkes-barre
South Carolina
AnMed Health Cancer Center
Anderson
Saint Francis Hospital
Greenville
Gibbs Cancer Center-Pelham
Greer
Spartanburg Regional Medical Center
Spartanburg
Upstate Carolina CCOP
Spartanburg
Tennessee
Wellmont Bristol Regional Medical Center
Bristol
Wellmont Medical Associates Oncology and Hematology-Bristol
Bristol
Wellmont Holston Valley Hospital and Medical Center
Kingsport
Wellmont Medical Associates Oncology and Hematology-Kingsport
Kingsport
Vanderbilt-Ingram Cancer Center
Nashville
Texas
Parkland Memorial Hospital
Dallas
University of Texas Southwestern Medical Center
Dallas
Virginia
University of Virginia
Charlottesville
Memorial Hospital Of Martinsville
Martinsville
Southwest VA Regional Cancer Center
Norton
Massey Cancer Center at Virginia Commonwealth University
Richmond
Washington
Kadlec Clinic Hematology and Oncology
Kennewick
EvergreenHealth Medical Center
Kirkland
Seattle Cancer Care Alliance at EvergreenHealth
Kirkland
Saint John Medical Center
Longview
Skagit Valley Hospital
Mount Vernon
Skagit Valley Hospital Regional Cancer Care Center
Mount Vernon
Olympic Medical Center
Port Angeles
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle
Seattle Cancer Care Alliance
Seattle
University of Washington Medical Center
Seattle
Olympic Medical Cancer Care Center
Sequim
Cancer Care Northwest - Spokane South
Spokane
Cancer Care Northwest-North Spokane
Spokane
Cancer Care Northwest-Valley
Spokane
Compass Oncology Vancouver
Vancouver
PeaceHealth Southwest Medical Center
Vancouver
Wenatchee Valley Hospital and Clinics
Wenatchee
Wisconsin
Langlade Hospital and Cancer Center
Antigo
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire
Sacred Heart Hospital
Eau Claire
Agnesian Cancer Center
Fond Du Lac
Green Bay Oncology at Saint Vincent Hospital
Green Bay
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay
Saint Mary's Hospital
Green Bay
Saint Vincent Hospital
Green Bay
UW Cancer Center Johnson Creek
Johnson Creek
Gundersen Lutheran Medical Center
La Crosse
University of Wisconsin Hospital and Clinics
Madison
Holy Family Memorial Hospital
Manitowoc
Bay Area Medical Center
Marinette
Marshfield Clinic
Marshfield
Saint Joseph's Hospital
Marshfield
Froedtert and the Medical College of Wisconsin
Milwaukee
Marshfield Clinic-Minocqua Center
Minocqua
D N Greenwald Center
Mukwonago
Cancer Center of Western Wisconsin
New Richmond
Oconomowoc Memorial Hospital-ProHealth Care Inc
Oconomowoc
Green Bay Oncology - Oconto Falls
Oconto Falls
Marshfield Clinic at James Beck Cancer Center
Rhinelander
Saint Mary's Hospital
Rhinelander
Marshfield Clinic-Rice Lake Center
Rice Lake
Saint Nicholas Hospital
Sheboygan
Marshfield Clinic Cancer Care at Saint Michael's Hospital
Stevens Point
Saint Michael's Hospital
Stevens Point
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay
Waukesha Memorial Hospital - ProHealth Care
Waukesha
Aspirus Regional Cancer Center
Wausau
Marshfield Clinic-Wausau Center
Wausau
Diagnostic and Treatment Center
Weston
Marshfield Clinic - Weston Center
Weston
Saint Clare's Hospital
Weston
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids
West Virginia
West Virginia University Healthcare
Morgantown
Wyoming
Rocky Mountain Oncology
Casper
Big Horn Basin Cancer Center
Cody
Billings Clinic-Cody
Cody
Welch Cancer Center
Sheridan
Other Locations
Canada
The Moncton Hospital
Moncton
Allan Blair Cancer Centre
Regina
Time Frame
Start Date: May 22, 2012
Estimated Completion Date: September 2031
Participants
Target number of participants: 373
Treatments
Experimental: Arm A
Patients receive induction therapy comprising rituximab IV on day 1 and bendamustine hydrochloride IV over 60 minutes on days 1-2. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to arm E.
Experimental: Arm B
Patients receive induction therapy comprising bortezomib IV subcutaneously (SC) on days 1, 4, 8, and 11 and rituximab and bendamustine hydrochloride as patients in arm A. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to arm F.
Experimental: Arm C
Patients receive induction therapy comprising rituximab and bendamustine hydrochloride as patients in arm A. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to arm G.
Experimental: Arm D
Patients receive bortezomib, rituximab, and bendamustine hydrochloride as patients in arm B. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to arm H.
Experimental: Arm E
Patients receive consolidation therapy comprising rituximab IV on day 1. Courses repeat every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Experimental: Arm F
Patients receive consolidation therapy comprising rituximab IV on day 1. Courses repeat every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Experimental: Arm G
Patients receive consolidation therapy comprising lenalidomide orally (PO) daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Experimental: Arm H
Patients receive consolidation therapy comprising lenalidomide PO daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Sponsors
Leads: Eastern Cooperative Oncology Group
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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