Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma
Ann Arbor Stage II Diffuse Large B-Cell Lymphoma, Ann Arbor Stage III Diffuse Large B-Cell Lymphoma, Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma
About this trial
This is an interventional treatment trial for Ann Arbor Stage II Diffuse Large B-Cell Lymphoma
Eligibility Criteria
Inclusion Criteria:
- PRE-REGISTRATION (STEP 0)
- Histologically confirmed DLBCL expressing CD20 antigen; patients with transformed lymphoma are excluded; in this regard, patients with composite lymphoma in the diagnostic tissue (concomitant DLBCL and follicular or other low-grade lymphoma component) are excluded; however, patients with DLBCL in primary diagnostic tissue but a bone marrow that shows low grade or indeterminate lymphoma are eligible; patients with known primary mediastinal large B-cell lymphoma (PMLBCL) are excluded; similarly, patients with known c-myc translocation (by fluorescence in situ hybridization) positive DLBCL are encouraged to participate in trials specifically designed for these patients; however patients with known c-myc DLBC positive are NOT excluded from this study; c-myc testing prior to study enrollment is NOT required
- Stages II bulky disease (defined as mass size of more than 10 cm), stage III, or IV (Ann Arbor staging); patients with stage I and stage II non-bulky disease are excluded from this study
- A paraffin-embedded tumor tissue specimen from the initial diagnostic biopsy has been located and ready to ship to the Mayo Clinic Lymphoma Laboratory following pre-registration; Note: excisional tumor biopsy is preferred; core needle biopsies will be considered adequate if there is enough tissue for the mandatory central pathology review immunohistochemistry and Genomics Education Partnership (GEP); submission of a tumor block is preferred, but if unavailable submit alternative materials
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Previously untreated and not receiving any other agent that would be considered as a treatment for the lymphoma; for subjects with severe systemic symptoms, compressive disease, or rapidly progressing symptomatic adenopathy, are allowed for lymphoma associated symptom treatment with up to 1 mg/kg/day prednisone, or equivalent, for a maximum of 7 days is permitted prior to beginning the treatment, at the discretion of the investigator; a washout period does not apply
- No known central nervous system (CNS) lymphoma or cerebrospinal fluid involvement with malignant lymphoma cells; these patients are usually treated with CNS directed therapy; screening for cerebrospinal fluid (CSF)/CNS involvement is NOT required but can be performed per treating medical doctor (MD) discretion; intrathecal (IT) methotrexate or IT cytarabine prophylaxis in patients with negative CSF who are felt to be at high risk of CNS relapse is allowed per local MD discretion; this should be noted on the treatment form
- Absence of history of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- Absence of history of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia; patients with a history of deep vein thrombosis(DVT)/pulmonary embolism (PE) or thrombophilia may participate if they are willing to be on full anticoagulation during the treatment if randomized to rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (R2CHOP) arm A; full anticoagulation is defined as warfarin, factor X inhibitors, or low molecular weight heparin at therapeutic doses
- Patient must be able and willing to receive anticoagulation therapy with aspirin 70-325 mg daily prophylaxis, low molecular weight heparin, factor X inhibitors or warfarin; patients unable or unwilling to take any prophylaxis are NOT eligible
- Absence of history of acquired immune deficiency syndrome (AIDS)-related conditions (other than the presenting DLBCL) or post-transplant lymphoproliferative disorder (PTLD) in immunocompromised patients; patients with human immunodeficiency virus (HIV) on antiretroviral therapy other than zidovudine (AZT) and/or stavudine and without prior AIDS defining conditions and adequate CD4 count (> 400) are eligible
- No other active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy; exceptions to this are as follows: localized non-melanotic skin cancer and any cancer that in the judgment of the investigator has been treated with curative intent and will not interfere with the study treatment plan and response assessment
- No history of radiation therapy to >= 25% of the bone marrow for other diseases or history of anthracycline therapy
- Patients must not be receiving erythroid stimulating agents (EPO: Procrit, Aranesp)
- RANDOMIZATION (STEP 1)
- Patient meets the eligibility criteria outlined above
- Site has received notification from Mayo Clinic - Rochester Division of Hematopathology of the central confirmation of diagnosis and tissue adequacy for mandatory research studies
- Patients must have measurable disease (at least 1 lesion of >= 1.5 cm in one diameter) as detected by computed tomography (CT) or the CT images of the positron emission tomography (PET)/CT
- International Prognostic Index (IPI) of 2 or greater
- Ejection fraction of >= 45% by either multi-gated acquisition (MUGA) scan or echocardiogram (ECHO)
- Absence of co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Absolute neutrophil count (ANC) >= 1500
- Platelets (PLT) >= 100,000
- Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin must be normal
- Alkaline (Alk.) phosphatase =< 3 x ULN unless evidence of the direct liver involvement by lymphoma - then =< 5 x ULN
- Aspartate aminotransferase (AST) =< 3 x ULN unless evidence of the direct liver involvement by lymphoma - then =< 5 x ULN
- Creatinine =< 2 x ULN or creatinine clearance (CrCl) > 30 ml/min
- Women must not be pregnant or breast-feeding
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- Men must agree to use a latex condom during sexual contact with a FCBP 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
Sites / Locations
- Alaska Breast Care and Surgery LLC
- Alaska Women's Cancer Care
- Anchorage Oncology Centre
- Katmai Oncology Group
- Providence Alaska Medical Center
- Mayo Clinic in Arizona
- Banner University Medical Center - Tucson
- University of Arizona Cancer Center-North Campus
- John L McClellan Memorial Veterans Hospital
- Kaiser Permanente-Deer Valley Medical Center
- Sutter Auburn Faith Hospital
- Kaiser Permanente-Baldwin Park
- Kaiser Permanente-Bellflower
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Kaiser Permanente - Harbor City
- Kaiser Permanente-Irvine
- Loma Linda University Medical Center
- Memorial Medical Center
- Palo Alto Medical Foundation-Camino Division
- Palo Alto Medical Foundation-Gynecologic Oncology
- Kaiser Permanente-Oakland
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Palo Alto Medical Foundation Health Care
- Stanford Cancer Institute Palo Alto
- Kaiser Permanente - Panorama City
- Kaiser Permanente-Richmond
- Sutter Medical Center Sacramento
- Kaiser Permanente-South Sacramento
- Kaiser Permanente - Sacramento
- Kaiser Permanente-San Diego Mission
- Kaiser Permanente-San Diego Zion
- California Pacific Medical Center-Pacific Campus
- Kaiser Permanente-San Francisco
- Kaiser Permanente-Santa Teresa-San Jose
- Stanford Cancer Center South Bay
- Kaiser Permanente-San Marcos
- Kaiser Permanente-San Rafael
- Kaiser Permanente Medical Center - Santa Clara
- Palo Alto Medical Foundation-Santa Cruz
- Kaiser Permanente-Santa Rosa
- Sutter Pacific Medical Foundation
- Kaiser Permanente-South San Francisco
- Palo Alto Medical Foundation-Sunnyvale
- Kaiser Permanente-Walnut Creek
- Kaiser Permanente-Woodland Hills
- Rocky Mountain Cancer Centers-Aurora
- The Medical Center of Aurora
- Boulder Community Hospital
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- Kaiser Permanente-Franklin
- Porter Adventist Hospital
- Colorado Blood Cancer Institute
- Presbyterian - Saint Lukes Medical Center - Health One
- Rocky Mountain Cancer Centers-Midtown
- SCL Health Saint Joseph Hospital
- Rocky Mountain Cancer Centers-Rose
- Rose Medical Center
- Western States Cancer Research NCORP
- Mercy Medical Center
- Mountain Blue Cancer Care Center - Swedish
- Swedish Medical Center
- Mountain Blue Cancer Care Center
- North Colorado Medical Center
- Rocky Mountain Cancer Centers-Greenwood Village
- Kaiser Permanente-Rock Creek
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony Hospital
- Rocky Mountain Cancer Centers-Littleton
- Littleton Adventist Hospital
- Rocky Mountain Cancer Centers-Sky Ridge
- Sky Ridge Medical Center
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- McKee Medical Center
- Parker Adventist Hospital
- Rocky Mountain Cancer Centers-Parker
- Saint Mary Corwin Medical Center
- Rocky Mountain Cancer Centers-Thornton
- SCL Health Lutheran Medical Center
- Smilow Cancer Hospital Care Center at Saint Francis
- The Hospital of Central Connecticut
- Yale University
- Bayhealth Hospital Kent Campus
- Beebe Medical Center
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- TidalHealth Nanticoke / Allen Cancer Center
- Sibley Memorial Hospital
- The Watson Clinic
- Orlando Health Cancer Institute
- Emory University Hospital/Winship Cancer Institute
- Northside Hospital
- Atlanta VA Medical Center
- Northside Hospital - Gwinnett
- Medical Center of Central Georgia
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Hawaii Cancer Care Inc - Waterfront Plaza
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Queen's Cancer Center - Kuakini
- The Cancer Center of Hawaii-Liliha
- Kaiser Permanente Moanalua Medical Center
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Cancer Institute - Boise
- Saint Luke's Cancer Institute - Fruitland
- Saint Luke's Cancer Institute - Meridian
- Saint Luke's Cancer Institute - Nampa
- Kootenai Clinic Cancer Services - Post Falls
- Saint Luke's Cancer Institute - Twin Falls
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Illinois CancerCare-Carthage
- Northwestern University
- Weiss Memorial Hospital
- UChicago Medicine Comprehensive Cancer Center - Saint Joseph Hospital
- Carle at The Riverfront
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Heartland Cancer Research NCORP
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Ascension Alexian Brothers - Elk Grove Village
- Illinois CancerCare-Eureka
- Illinois CancerCare-Galesburg
- Northwestern Medicine Cancer Center Delnor
- Ingalls Memorial Hospital
- Hinsdale Hematology Oncology Associates Incorporated
- Duly Health and Care Joliet
- Illinois CancerCare-Kewanee Clinic
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/Charleston
- Trinity Medical Center
- Illinois CancerCare-Monmouth
- Illinois Cancer Specialists-Niles
- Cancer Care Center of O'Fallon
- Illinois CancerCare-Ottawa Clinic
- Illinois CancerCare-Pekin
- Illinois CancerCare-Peoria
- Illinois CancerCare-Peru
- Illinois CancerCare-Princeton
- West Suburban Medical Center
- Swedish American Hospital
- SwedishAmerican Regional Cancer Center/ACT
- Central Illinois Hematology Oncology Center
- Southern Illinois University School of Medicine
- Springfield Clinic
- Memorial Medical Center
- Carle Cancer Center
- The Carle Foundation Hospital
- Northwestern Medicine Cancer Center Warrenville
- Elkhart Clinic
- Michiana Hematology Oncology PC-Elkhart
- Elkhart General Hospital
- Indiana University/Melvin and Bren Simon Cancer Center
- IU Health Central Indiana Cancer Centers-East
- Community Howard Regional Health
- IU Health La Porte Hospital
- IU Health Arnett Cancer Care
- Premier Oncology Hematology Associates
- Michiana Hematology Oncology PC-Mishawaka
- Saint Joseph Regional Medical Center-Mishawaka
- IU Health Ball Memorial Hospital
- Michiana Hematology Oncology PC-Plymouth
- Reid Health
- Michiana Hematology Oncology PC-South Bend
- Northern Indiana Cancer Research Consortium
- Michiana Hematology Oncology PC-Westville
- McFarland Clinic - Ames
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Iowa-Wide Oncology Research Coalition NCORP
- Medical Oncology and Hematology Associates-Des Moines
- Mercy Medical Center - Des Moines
- Mission Cancer and Blood - Laurel
- Mercy Medical Center - North Iowa
- Ottumwa Regional Health Center
- Siouxland Regional Cancer Center
- MercyOne Waterloo Cancer Center
- Mercy Medical Center-West Lakes
- Lawrence Memorial Hospital
- Kansas City NCI Community Oncology Research Program
- Wesley Medical Center
- Flaget Memorial Hospital
- Jewish Hospital
- UofL Health Medical Center Northeast
- Ochsner Health Center-Summa
- Ochsner Medical Center Kenner
- Ochsner LSU Health Monroe Medical Center
- Ochsner Medical Center Jefferson
- LSU Health Sciences Center at Shreveport
- Harold Alfond Center for Cancer Care
- Eastern Maine Medical Center
- Lafayette Family Cancer Center-EMMC
- Greater Baltimore Medical Center
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Christiana Care - Union Hospital
- TidalHealth Peninsula Regional
- Tufts Medical Center
- Boston Medical Center
- Baystate Medical Center
- UMass Memorial Medical Center - University Campus
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- Bronson Battle Creek
- Beaumont Hospital - Dearborn
- Wayne State University/Karmanos Cancer Institute
- Ascension Saint John Hospital
- Green Bay Oncology - Escanaba
- Genesys Hurley Cancer Institute
- Spectrum Health at Butterworth Campus
- Trinity Health Grand Rapids Hospital
- Allegiance Health
- West Michigan Cancer Center
- Trinity Health Saint Mary Mercy Livonia Hospital
- Trinity Health Muskegon Hospital
- Saint Joseph Mercy Oakland
- Lake Huron Medical Center
- Spectrum Health Reed City Hospital
- Ascension Saint Mary's Hospital
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Munson Medical Center
- Saint John Macomb-Oakland Hospital
- Sanford Joe Lueken Cancer Center
- Fairview Ridges Hospital
- Mercy Hospital
- Essentia Health Cancer Center
- Saint Luke's Hospital of Duluth
- Fairview Southdale Hospital
- Lake Region Healthcare Corporation-Cancer Care
- Unity Hospital
- Hutchinson Area Health Care
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Health Partners Inc
- North Memorial Medical Health Center
- Mayo Clinic in Rochester
- Coborn Cancer Center at Saint Cloud Hospital
- Metro Minnesota Community Oncology Research Consortium
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- University of Mississippi Medical Center
- Central Care Cancer Center - Bolivar
- Saint Francis Medical Center
- Southeast Cancer Center
- Saint Luke's Hospital
- Capital Region Southwest Campus
- Saint Luke's Hospital of Kansas City
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Saint Louis Cancer and Breast Institute-South City
- Missouri Baptist Medical Center
- Mercy Hospital Saint Louis
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Billings Clinic Cancer Center
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Kalispell Regional Medical Center
- Saint Patrick Hospital - Community Hospital
- Community Medical Hospital
- CHI Health Saint Francis
- CHI Health Good Samaritan
- Nebraska Hematology and Oncology
- Nebraska Cancer Research Center
- Southeast Nebraska Cancer Center - 68th Street Place
- University of Nebraska Medical Center
- Cancer and Blood Specialists-Henderson
- Comprehensive Cancer Centers of Nevada - Henderson
- Las Vegas Cancer Center-Henderson
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
- GenesisCare USA - Henderson
- University Medical Center of Southern Nevada
- Cancer and Blood Specialists-Shadow
- Radiation Oncology Centers of Nevada Central
- GenesisCare USA - Las Vegas
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
- Radiation Oncology Centers of Nevada Southeast
- Cancer Therapy and Integrative Medicine
- Comprehensive Cancer Centers of Nevada - Northwest
- GenesisCare USA - Vegas Tenaya
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
- Comprehensive Cancer Centers of Nevada-Summerlin
- Las Vegas Cancer Center-Medical Center
- Comprehensive Cancer Centers of Nevada
- GenesisCare USA - Fort Apache
- OptumCare Cancer Care at Fort Apache
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
- Comprehensive Cancer Centers of Nevada - Central Valley
- Nevada Cancer Research Foundation NCORP
- New Hampshire Oncology Hematology PA-Concord
- Wentworth-Douglass Hospital
- LRGHealthcare-Lakes Region General Hospital
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
- Solinsky Center for Cancer Care
- Cooper Hospital University Medical Center
- Englewood Hospital and Medical Center
- Saint Barnabas Medical Center
- Virtua Memorial
- Inspira Medical Center Mullica Hill
- The Valley Hospital-Luckow Pavilion
- Valley Hospital
- Inspira Medical Center Vineland
- Valley Health System-Hematology/Oncology
- University of New Mexico Cancer Center
- Presbyterian Kaseman Hospital
- Memorial Medical Center - Las Cruces
- Christus Saint Vincent Regional Cancer Center
- Montefiore Medical Center-Einstein Campus
- Montefiore Medical Center-Weiler Hospital
- Montefiore Medical Center - Moses Campus
- Kings County Hospital
- State University of New York Downstate Medical Center
- Roswell Park Cancer Institute
- Hematology Oncology Associates of Central New York-East Syracuse
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
- Champlain Valley Physicians Hospital Medical Center
- University of Rochester
- State University of New York Upstate Medical University
- Randolph Hospital
- UNC Lineberger Comprehensive Cancer Center
- Southeastern Medical Oncology Center-Clinton
- Southeastern Medical Oncology Center-Goldsboro
- Wayne Memorial Hospital
- Cone Health Cancer Center
- Hendersonville Hematology and Oncology at Pardee
- Margaret R Pardee Memorial Hospital
- Southeastern Medical Oncology Center-Jacksonville
- Vidant Oncology-Kinston
- Annie Penn Memorial Hospital
- Iredell Memorial Hospital
- Marion L Shepard Cancer Center at Vidant Beaufort Hospital
- Wake Forest University Health Sciences
- Sanford Bismarck Medical Center
- Sanford Broadway Medical Center
- Sanford Clinic North-Fargo
- Sanford Roger Maris Cancer Center
- Summa Health System - Akron Campus
- Cleveland Clinic Akron General
- Summa Health System - Barberton Campus
- Cleveland Clinic Mercy Hospital
- Geauga Hospital
- University of Cincinnati Cancer Center-UC Medical Center
- Good Samaritan Hospital - Cincinnati
- TriHealth Cancer Institute-Westside
- TriHealth Cancer Institute-Anderson
- Case Western Reserve University
- MetroHealth Medical Center
- Ohio State University Comprehensive Cancer Center
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Columbus NCI Community Oncology Research Program
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Miami Valley Hospital North
- Mercy Cancer Center-Elyria
- Blanchard Valley Hospital
- Saint Rita's Medical Center
- Marietta Memorial Hospital
- Toledo Clinic Cancer Centers-Maumee
- UH Seidman Cancer Center at Landerbrook Health Center
- UH Seidman Cancer Center at Lake Health Mentor Campus
- Licking Memorial Hospital
- UH Seidman Cancer Center at Firelands Regional Medical Center
- Springfield Regional Cancer Center
- Springfield Regional Medical Center
- ProMedica Flower Hospital
- University of Toledo
- Toledo Clinic Cancer Centers-Toledo
- Saint Ann's Hospital
- UH Seidman Cancer Center at Saint John Medical Center
- University of Oklahoma Health Sciences Center
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Clackamas Radiation Oncology Center
- Providence Cancer Institute Clackamas Clinic
- Bay Area Hospital
- Providence Newberg Medical Center
- Providence Willamette Falls Medical Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Lehigh Valley Hospital-Cedar Crest
- Saint Luke's University Hospital-Bethlehem Campus
- Bryn Mawr Hospital
- Geisinger Medical Center
- Doylestown Hospital
- Delaware County Memorial Hospital
- Ephrata Cancer Center
- Ephrata Community Hospital
- Adams Cancer Center
- Cherry Tree Cancer Center
- Geisinger Medical Center-Cancer Center Hazleton
- Penn State Milton S Hershey Medical Center
- Geisinger Medical Oncology-Lewisburg
- Paoli Memorial Hospital
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- Temple University Hospital
- Pottstown Hospital
- Geisinger Cancer Services-Pottsville
- Hematology and Oncology Associates of North East Pennsylvania
- Geisinger Medical Oncology-Selinsgrove
- Grand View Hospital
- Mount Nittany Medical Center
- Chester County Hospital
- Reading Hospital
- Geisinger Wyoming Valley/Henry Cancer Center
- Lankenau Medical Center
- WellSpan Health-York Hospital
- Prisma Health Cancer Institute - Spartanburg
- Prisma Health Cancer Institute - Easley
- Greenville Health System Cancer Institute-Andrews
- Prisma Health Cancer Institute - Butternut
- Prisma Health Cancer Institute - Faris
- Prisma Health Greenville Memorial Hospital
- Prisma Health Cancer Institute - Eastside
- Prisma Health Cancer Institute - Greer
- Prisma Health Cancer Institute - Seneca
- Rapid City Regional Hospital
- Sanford Cancer Center Oncology Clinic
- Avera Cancer Institute
- Sanford USD Medical Center - Sioux Falls
- Vanderbilt University/Ingram Cancer Center
- Dell Seton Medical Center at The University of Texas
- Parkland Memorial Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- Brooke Army Medical Center
- Covenant Medical Center-Lakeside
- Texas Tech University Health Sciences Center-Lubbock
- University of Texas Health Science Center at San Antonio
- Huntsman Cancer Institute/University of Utah
- University of Virginia Cancer Center
- Augusta Health Center for Cancer and Blood Disorders
- Sovah Health Martinsville
- Swedish Cancer Institute-Edmonds
- PeaceHealth Saint John Medical Center
- Swedish Medical Center-Ballard Campus
- Swedish Medical Center-First Hill
- PeaceHealth Southwest Medical Center
- West Virginia University Charleston Division
- Langlade Hospital and Cancer Center
- ThedaCare Regional Cancer Center
- Aurora Cancer Care-Southern Lakes VLCC
- HSHS Sacred Heart Hospital
- Marshfield Clinic Cancer Center at Sacred Heart
- Aurora Health Care Germantown Health Center
- Aurora Cancer Care-Grafton
- Green Bay Oncology at Saint Vincent Hospital
- Bellin Memorial Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Aurora BayCare Medical Center
- UW Cancer Center Johnson Creek
- Aurora Cancer Care-Kenosha South
- Gundersen Lutheran Medical Center
- Dean Hematology and Oncology Clinic
- University of Wisconsin Carbone Cancer Center
- Holy Family Memorial Hospital
- Aurora Bay Area Medical Group-Marinette
- Bay Area Medical Center
- Marshfield Medical Center-Marshfield
- Marshfield Medical Center
- Aurora Cancer Care-Milwaukee
- Aurora Saint Luke's Medical Center
- Medical College of Wisconsin
- Aurora Sinai Medical Center
- Marshfield Clinic-Minocqua Center
- Cancer Center of Western Wisconsin
- ProHealth Oconomowoc Memorial Hospital
- Saint Vincent Hospital Cancer Center at Oconto Falls
- Vince Lombardi Cancer Clinic - Oshkosh
- Aurora Cancer Care-Racine
- Ascension Saint Mary's Hospital
- Saint Mary's Hospital
- Lakeview Medical Center-Marshfield Clinic
- Marshfield Medical Center-Rice Lake
- Vince Lombardi Cancer Clinic-Sheboygan
- Ascension Saint Michael's Hospital
- Green Bay Oncology - Sturgeon Bay
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- Aurora Cancer Care-Waukesha
- ProHealth Waukesha Memorial Hospital
- UW Cancer Center at ProHealth Care
- Aspirus Regional Cancer Center
- Marshfield Clinic-Wausau Center
- Aurora Cancer Care-Milwaukee West
- Aurora West Allis Medical Center
- Diagnostic and Treatment Center
- Marshfield Medical Center - Weston
- Aspirus Cancer Care - Wisconsin Rapids
- Marshfield Clinic - Wisconsin Rapids Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm A (rituximab, combination chemotherapy, lenalidomide)
Arm B (rituximab, combination chemotherapy)
Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1; prednisone PO on days 1-5; and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients receive rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone as in Arm A. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.