A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma
Liver Lymphoma, Mantle Cell Lymphoma
About this trial
This is an interventional treatment trial for Liver Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Baseline measurements and evaluations must be obtained within 6 weeks of randomization to the study. Abnormal PET or CT scans may constitute evaluable disease. Patient must have at least one objective measurable disease parameter. Measurable disease in the liver is required if the liver is the only site of lymphoma.
- MIPI score must be calculated and entered in Oncology Patient Enrollment Network (OPEN).
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Patients must have untreated histologically confirmed mantle cell lymphoma, with cyclin D1 (BCL1) expression by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescent in situ hybridization (FISH). The diagnosis must be confirmed by formal hematopathology review at the enrolling center.
- Patients being treated with gastric reducing agents proton pump inhibitors must be switched to an alternative drug before starting acalabrutinib.
Absolute neutrophil count (ANC) >= 1,000/mcL (obtained with 14 days of randomization). If disease includes marrow involvement or hypersplenism, please reference the below revised ANC requirement:
- ANC >= 500/mcL
Platelets >= 75,000 mcL (obtained with 14 days of randomization). If disease includes involvement or hypersplenism, please reference the below revised platelet requirement:
- Platelets >= 25,000/mcL
Total bilirubin =< 2 x institutional upper limit of normal (ULN) (obtained with 14 days of randomization). If disease includes hepatic infiltration or is causing biliary obstruction, or if elevated bilirubin is due to Gilbert's disease, please reference the below revised bilirubin requirements:
- Bilirubin =< 3 x institutional ULN
Aspartate aminotransferase (AST) and alanine transaminase (ALT) =< 2.5 x institutional ULN (obtained with 14 days of randomization). If disease includes hepatic infiltration or is causing biliary obstruction, or if elevated bilirubin is due to Gilbert's disease, please reference the below revised AST/ALT requirements:
- AST/ALT =< 5 x institutional ULN
- Prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (aPTT) in the absence of lupus anticoagulant) < 2 x institutional ULN (obtained with 14 days of randomization). Patients receiving anticoagulant therapy (other than warfarin or equivalent vitamin K antagonists which are excluded), higher INR/aPTT may be permitted to enroll to this study after discussion with the primary investigator (PI).
- Creatinine =< institutional ULN, OR glomerular filtration rate (GFR) >= 40 mL/min/1.73 m^2 (obtained with 14 days of randomization).
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional classification. To be eligible for this trial, patients should be class 2B or better.
- Patients must have a QT interval (QTc) =< 480 msec obtained within 14 days of randomization.
- Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. Patients must also not expect to conceive or father children from the time of registration, while on study treatment, and until 12 months after the last dose of study treatment. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: has achieved menarche at some point, has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- Women of childbearing potential and sexually active males must agree to use accepted and effective method(s) of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for 12 months after treatment ends.
- Patients are not eligible if they require treatment with a strong cytochrome P450 (CYP) 3A inhibitor.
Patients may not have received the following within 7 days prior to the first dose of study drug:
- Strong and moderate CYP3A inhibitors
- Strong and moderate CYP3A inducers
Patients are ineligible if they have any of the following:
- Malabsorption syndrome or disease significantly affecting gastrointestinal function.
- Active bleeding or history of bleeding diathesis (e.g. hemophilia or von Willebrand disease).
- Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenia purpura).
- Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (e.g. phenprocoumon) within 7 days of first dose of study drug.
- History of significant cerebrovascular disease/event, including stroke or intracranial hemorrhage, within 6 months before the first dose of study drug.
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infections at study enrollment (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
- History of severe allergic reaction attributed to compounds of similar chemical or biologic composition to rituximab, bendamustine, cytarabine, or acalabrutinib.
Patients must be able to fulfill one of the following eligibility requirements pertaining to biospecimen availability for submission following randomization:
- Archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen from the original diagnostic biopsy is available for submission OR,
If tumor tissue is not available, peripheral blood collected prior to initiation of protocol therapy will be submitted
- NOTE: Biospecimens must be submitted within 60 days following randomization to Adaptive Biotechnologies for ClonoSEQ ID molecular marker identification of unique clonal immunoglobulin deoxyribonucleic acid (DNA) sequence. If peripheral blood will be submitted, Adaptive Biotechnologies should be contacted prior to patient randomization for guidance pertaining to collection and submission requirements.
Sites / Locations
- Anchorage Associates in Radiation Medicine
- Anchorage Radiation Therapy Center
- Alaska Breast Care and Surgery LLC
- Alaska Oncology and Hematology LLC
- Alaska Women's Cancer Care
- Anchorage Oncology Centre
- Katmai Oncology Group
- Providence Alaska Medical Center
- Fairbanks Memorial Hospital
- Cancer Center at Saint Joseph's
- Banner University Medical Center - Tucson
- University of Arizona Cancer Center-North Campus
- Mercy Hospital Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs
- Kaiser Permanente-Anaheim
- Mission Hope Medical Oncology - Arroyo Grande
- Kaiser Permanente-Baldwin Park
- Kaiser Permanente-Bellflower
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Kaiser Permanente-Fontana
- Kaiser Permanente - Harbor City
- Kaiser Permanente-Irvine
- Kaiser Permanente Los Angeles Medical Center
- Kaiser Permanente West Los Angeles
- Kaiser Permanente-Ontario
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Desert Regional Medical Center
- Kaiser Permanente - Panorama City
- Kaiser Permanente-Riverside
- Mercy Cancer Center - Sacramento
- Kaiser Permanente-San Diego Mission
- Kaiser Permanente-San Diego Zion
- Pacific Central Coast Health Center-San Luis Obispo
- Kaiser Permanente-San Marcos
- Mission Hope Medical Oncology - Santa Maria
- Kaiser Permanente-Woodland Hills
- Woodland Memorial Hospital
- Rocky Mountain Cancer Centers-Aurora
- The Medical Center of Aurora
- Boulder Community Hospital
- Boulder Community Foothills Hospital
- Rocky Mountain Cancer Centers-Boulder
- Rocky Mountain Cancer Centers - Centennial
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- Saint Francis Cancer Center
- Cancer Center of Colorado at Sloan's Lake
- National Jewish Health-Main Campus
- The Women's Imaging Center
- 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 Surgical Care
- Mercy Medical Center
- Southwest Oncology PC
- Mountain Blue Cancer Care Center - Swedish
- Rocky Mountain Cancer Centers - Swedish
- Swedish Medical Center
- The Melanoma and Skin Cancer Institute
- National Jewish Health-Western Hematology Oncology
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Good Samaritan Medical Center
- 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
- Saint Mary Corwin Medical Center
- National Jewish Health-Northern Hematology Oncology
- Rocky Mountain Cancer Centers-Thornton
- SCL Health Lutheran Medical Center
- Sibley Memorial Hospital
- Mayo Clinic in Florida
- Emory University Hospital Midtown
- Emory University Hospital/Winship Cancer Institute
- Emory Saint Joseph's Hospital
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Cancer Institute - Boise
- Saint Alphonsus Cancer Care Center-Caldwell
- Kootenai Health - Coeur d'Alene
- Walter Knox Memorial Hospital
- Saint Luke's Cancer Institute - Fruitland
- Idaho Urologic Institute-Meridian
- Saint Luke's Cancer Institute - Meridian
- Saint Alphonsus Medical Center-Nampa
- Saint Luke's Cancer Institute - Nampa
- Kootenai Clinic Cancer Services - Post Falls
- Kootenai Cancer Clinic
- Saint Luke's Cancer Institute - Twin Falls
- Saint Anthony's Health
- Rush - Copley Medical Center
- Advocate Good Shepherd Hospital
- Illinois CancerCare-Bloomington
- Loyola Center for Health at Burr Ridge
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- SIH Cancer Institute
- Illinois CancerCare-Carthage
- Centralia Oncology Clinic
- Northwestern University
- John H Stroger Jr Hospital of Cook County
- University of Chicago Comprehensive Cancer Center
- Advocate Illinois Masonic Medical Center
- AMG Crystal Lake - Oncology
- Carle on Vermilion
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Northwestern Medicine Cancer Center Kishwaukee
- Illinois CancerCare-Dixon
- Advocate Good Samaritan Hospital
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Advocate Sherman Hospital
- Illinois CancerCare-Eureka
- NorthShore University HealthSystem-Evanston Hospital
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Northwestern Medicine Cancer Center Delnor
- NorthShore University HealthSystem-Glenbrook Hospital
- Ingalls Memorial Hospital
- Advocate South Suburban Hospital
- NorthShore University HealthSystem-Highland Park Hospital
- Loyola Medicine Homer Glen
- Illinois CancerCare-Kewanee Clinic
- Northwestern Medicine Lake Forest Hospital
- AMG Libertyville - Oncology
- Condell Memorial Hospital
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/Charleston
- Loyola University Medical Center
- Marjorie Weinberg Cancer Center at Loyola-Gottlieb
- Good Samaritan Regional Health Center
- UC Comprehensive Cancer Center at Silver Cross
- Cancer Care Center of O'Fallon
- Advocate Christ Medical Center
- University of Chicago Medicine-Orland Park
- Illinois CancerCare-Ottawa Clinic
- Advocate Lutheran General Hospital
- Illinois CancerCare-Pekin
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Illinois CancerCare-Peoria
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Valley Radiation Oncology
- Illinois CancerCare-Princeton
- Southern Illinois University School of Medicine
- Springfield Clinic
- Memorial Medical Center
- Southwest Illinois Health Services LLP
- Carle Cancer Center
- The Carle Foundation Hospital
- Northwestern Medicine Cancer Center Warrenville
- Illinois CancerCare - Washington
- Rush-Copley Healthcare Center
- Mary Greeley Medical Center
- McFarland Clinic PC - Ames
- McFarland Clinic PC-Boone
- Saint Anthony Regional Hospital
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Alegent Health Mercy Hospital
- Greater Regional Medical Center
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates-Des Moines
- Broadlawns Medical Center
- Mercy Medical Center - Des Moines
- Mission Cancer and Blood - Laurel
- Iowa Lutheran Hospital
- McFarland Clinic PC-Trinity Cancer Center
- Trinity Regional Medical Center
- McFarland Clinic PC-Jefferson
- McFarland Clinic PC-Marshalltown
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- Central Care Cancer Center - Garden City
- Central Care Cancer Center - Great Bend
- HaysMed University of Kansas Health System
- University of Kansas Cancer Center
- Lawrence Memorial Hospital
- Olathe Health Cancer Center
- University of Kansas Cancer Center-Overland Park
- Ascension Via Christi - Pittsburg
- Salina Regional Health Center
- Cotton O'Neil Cancer Center / Stormont Vail Health
- University of Kansas Health System Saint Francis Campus
- University of Kansas Hospital-Westwood Cancer Center
- Flaget Memorial Hospital
- Commonwealth Cancer Center-Corbin
- Saint Joseph Hospital
- Saint Joseph Radiation Oncology Resource Center
- Saint Joseph Hospital East
- Saint Joseph London
- Jewish Hospital
- Saints Mary and Elizabeth Hospital
- UofL Health Medical Center Northeast
- Saint Joseph Mount Sterling
- Jewish Hospital Medical Center South
- Ochsner LSU Health Monroe Medical Center
- Ochsner Medical Center Jefferson
- LSU Health Sciences Center at Shreveport
- Eastern Maine Medical Center
- Lafayette Family Cancer Center-EMMC
- Johns Hopkins University/Sidney Kimmel Cancer Center
- UMass Memorial Medical Center - University Campus
- Hickman Cancer Center
- University of Michigan Comprehensive Cancer Center
- Bronson Battle Creek
- Wayne State University/Karmanos Cancer Institute
- Weisberg Cancer Treatment Center
- Helen DeVos Children's Hospital at Spectrum Health
- Mercy Health Saint Mary's
- Spectrum Health at Butterworth Campus
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Ascension Borgess Cancer Center
- Borgess Medical Center
- Toledo Clinic Cancer Centers-Monroe
- Mercy Health Mercy Campus
- Lakeland Hospital Niles
- Cancer and Hematology Centers of Western Michigan - Norton Shores
- Spectrum Health Reed City Hospital
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Munson Medical Center
- Metro Health Hospital
- Riverwood Healthcare Center
- Essentia Health - Baxter Clinic
- Sanford Joe Lueken Cancer Center
- Essentia Health Saint Joseph's Medical Center
- Fairview Ridges Hospital
- Minnesota Oncology - Burnsville
- Cambridge Medical Center
- Mercy Hospital
- Essentia Health - Deer River Clinic
- Essentia Health Saint Mary's - Detroit Lakes Clinic
- Essentia Health Cancer Center
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Fairview Southdale Hospital
- Essentia Health - Ely Clinic
- Lake Region Healthcare Corporation-Cancer Care
- Essentia Health - Fosston
- Unity Hospital
- Essentia Health Hibbing Clinic
- Essentia Health - International Falls Clinic
- Fairview Clinics and Surgery Center Maple Grove
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Health Partners Inc
- Monticello Cancer Center
- Essentia Health - Moose Lake Clinic
- New Ulm Medical Center
- Essentia Health - Park Rapids
- Fairview Northland Medical Center
- North Memorial Medical Health Center
- Mayo Clinic in Rochester
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Essentia Health Sandstone
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Sanford Thief River Falls Medical Center
- Essentia Health Virginia Clinic
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Sanford Cancer Center Worthington
- Fairview Lakes Medical Center
- Saint Louis Cancer and Breast Institute-Ballwin
- Central Care Cancer Center - Bolivar
- Parkland Health Center-Bonne Terre
- Cox Cancer Center Branson
- Saint Francis Medical Center
- Southeast Cancer Center
- Saint Luke's Hospital
- Siteman Cancer Center at West County Hospital
- Parkland Health Center - Farmington
- Capital Region Southwest Campus
- Freeman Health System
- Mercy Hospital Joplin
- Truman Medical Centers
- University of Kansas Cancer Center - North
- University of Kansas Cancer Center - Lee's Summit
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Saint Louis Cancer and Breast Institute-South City
- Washington University School of Medicine
- Mercy Hospital South
- Siteman Cancer Center-South County
- Missouri Baptist Medical Center
- Siteman Cancer Center at Christian Hospital
- Mercy Hospital Saint Louis
- Siteman Cancer Center at Saint Peters Hospital
- Sainte Genevieve County Memorial Hospital
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Mercy Hospital Washington
- Community Hospital of Anaconda
- Billings Clinic Cancer Center
- Saint Vincent Healthcare
- Saint Vincent Frontier Cancer Center
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Great Falls Clinic
- Kalispell Regional Medical Center
- Saint Patrick Hospital - Community Hospital
- Community Medical Hospital
- CHI Health Saint Francis
- CHI Health Good Samaritan
- Saint Elizabeth Regional Medical Center
- Nebraska Medicine-Village Pointe
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- Creighton University Medical Center
- University of Nebraska Medical Center
- Midlands Community Hospital
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
- Morristown Medical Center
- Overlook Hospital
- Roswell Park Cancer Institute
- Glens Falls Hospital
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- NYP/Weill Cornell Medical Center
- University of Rochester
- UNC Lineberger Comprehensive Cancer Center
- Southeastern Medical Oncology Center-Clinton
- Southeastern Medical Oncology Center-Goldsboro
- Southeastern Medical Oncology Center-Jacksonville
- Vidant Oncology-Kenansville
- Vidant Oncology-Kinston
- Vidant Oncology-Richlands
- Sanford Bismarck Medical Center
- Essentia Health Cancer Center-South University Clinic
- Sanford South University Medical Center
- Southpointe-Sanford Medical Center Fargo
- Sanford Medical Center Fargo
- Sanford Broadway Medical Center
- Sanford Roger Maris Cancer Center
- Essentia Health - Jamestown Clinic
- University of Cincinnati Cancer Center-UC Medical Center
- Good Samaritan Hospital - Cincinnati
- Bethesda North Hospital
- TriHealth Cancer Institute-Westside
- TriHealth Cancer Institute-Anderson
- Case Western Reserve University
- MetroHealth Medical Center
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- Mercy Health Perrysburg Cancer Center
- ProMedica Flower Hospital
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
- Mercy Health - Saint Anne Hospital
- Toledo Clinic Cancer Centers-Toledo
- University of Cincinnati Cancer Center-West Chester
- University of Oklahoma Health Sciences Center
- Mercy Hospital Oklahoma City
- Saint Alphonsus Medical Center-Baker City
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Providence Cancer Institute Clackamas Clinic
- Bay Area Hospital
- Providence Newberg Medical Center
- Saint Alphonsus Medical Center-Ontario
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Oregon Health and Science University
- Saint Charles Health System-Redmond
- Rhode Island Hospital
- Prisma Health Cancer Institute - Spartanburg
- Medical University of South Carolina
- Prisma Health Cancer Institute - Easley
- Prisma Health Cancer Institute - Butternut
- Prisma Health Cancer Institute - Faris
- Prisma Health Cancer Institute - Eastside
- Prisma Health Cancer Institute - Greer
- Prisma Health Cancer Institute - Seneca
- Sanford Cancer Center Oncology Clinic
- Avera Cancer Institute
- Sanford USD Medical Center - Sioux Falls
- Saint Joseph Regional Cancer Center
- American Fork Hospital / Huntsman Intermountain Cancer Center
- Sandra L Maxwell Cancer Center
- Logan Regional Hospital
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center
- Riverton Hospital
- Saint George Regional Medical Center
- Utah Cancer Specialists-Salt Lake City
- Huntsman Cancer Institute/University of Utah
- LDS Hospital
- Central Vermont Medical Center/National Life Cancer Treatment
- University of Vermont Medical Center
- University of Vermont and State Agricultural College
- Norris Cotton Cancer Center-North
- University of Virginia Cancer Center
- Virginia Commonwealth University/Massey Cancer Center
- Providence Regional Cancer System-Aberdeen
- MultiCare Auburn Medical Center
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Harrison Medical Center
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-Centralia
- Swedish Cancer Institute-Edmonds
- Saint Elizabeth Hospital
- Providence Regional Cancer Partnership
- Saint Francis Hospital
- MultiCare Gig Harbor Medical Park
- Swedish Cancer Institute-Issaquah
- Kadlec Clinic Hematology and Oncology
- Providence Regional Cancer System-Lacey
- Saint Clare Hospital
- PeaceHealth Saint John Medical Center
- Jefferson Healthcare
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- MultiCare Good Samaritan Hospital
- Pacific Gynecology Specialists
- Swedish Medical Center-Ballard Campus
- Swedish Medical Center-Cherry Hill
- Swedish Medical Center-First Hill
- PeaceHealth United General Medical Center
- Providence Regional Cancer System-Shelton
- MultiCare Deaconess Cancer and Blood Specialty Center - Valley
- MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
- MultiCare Deaconess Cancer and Blood Specialty Center - North
- Franciscan Research Center-Northwest Medical Plaza
- Mary Bridge Children's Hospital and Health Center
- MultiCare Tacoma General Hospital
- Northwest Medical Specialties PLLC
- PeaceHealth Southwest Medical Center
- Providence Saint Mary Regional Cancer Center
- Providence Regional Cancer System-Yelm
- Langlade Hospital and Cancer Center
- ThedaCare Regional Cancer Center
- Duluth Clinic Ashland
- Northwest Wisconsin Cancer Center
- Aurora Cancer Care-Southern Lakes VLCC
- Aurora Saint Luke's South Shore
- Marshfield Medical Center-EC Cancer Center
- Aurora Health Center-Fond du Lac
- Aurora Health Care Germantown Health Center
- Aurora Cancer Care-Grafton
- Bellin Memorial Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Aurora BayCare Medical Center
- Essentia Health-Hayward Clinic
- Aurora Cancer Care-Kenosha South
- Gundersen Lutheran Medical Center
- University of Wisconsin Carbone Cancer Center
- Aurora Bay Area Medical Group-Marinette
- Marshfield Medical Center-Marshfield
- Aspirus Medford Hospital
- Aurora Cancer Care-Milwaukee
- Aurora Saint Luke's Medical Center
- Medical College of Wisconsin
- Aurora Sinai Medical Center
- Marshfield Clinic-Minocqua Center
- ProHealth D N Greenwald 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
- Marshfield Medical Center-Rice Lake
- Vince Lombardi Cancer Clinic-Sheboygan
- Essentia Health-Spooner Clinic
- Ascension Saint Michael's Hospital
- Marshfield Medical Center-River Region at Stevens Point
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
- Aurora Medical Center in Summit
- Essentia Health Saint Mary's Hospital - Superior
- Vince Lombardi Cancer Clinic-Two Rivers
- ProHealth Waukesha Memorial Hospital
- UW Cancer Center at ProHealth Care
- Aspirus Regional Cancer Center
- Aurora Cancer Care-Milwaukee West
- Aurora West Allis Medical Center
- Marshfield Medical Center - Weston
- Aspirus Cancer Care - Wisconsin Rapids
- Cheyenne Regional Medical Center-West
- Billings Clinic-Cody
- Welch Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Arm A (bendamustine, rituximab, cytarabine)
Arm B (acalabrutinib, bendamustine, rituximab, cytarabine)
Arm C (acalabrutinib, bendamustine, rituximab)
Patients receive bendamustine IV on days 1 and 2 and rituximab IV on day 1 or 2. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 4, patients receive rituximab IV on day 1 and cytarabine IV every Q12 hours on days 1 and 2. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Patients receive PO BID on days 1-28, bendamustine IV on days 1 and 2, and rituximab IV on day 1 or 2. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 4, patients receive acalabrutinib PO BID on days 1-7 and 22-28, rituximab IV on day 1, and cytarabine IV Q12 hours on days 1 and 2. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Patients receive acalabrutinib PO BID on days 1-28, bendamustine IV on days 1 and 2, and rituximab IV on day 1 or 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.