Blood Cancer

EA4181



A Comparison of Three Chemotherapy Regimens for Patients with Newly Diagnosed Mantle Cell Lymphoma

STATUS: Active


This phase II trial compares three chemotherapy regimens consisting of bendamustine, rituximab, high dose cytarabine, and acalabrutinib and studies how well they work in treating patients with newly diagnosed mantle cell lymphoma. Drugs used in chemotherapy, such as bendamustine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. This study is being done to find out if one the drug combinations of bendamustine, rituximab, high dose cytarabine, and acalabrutinib is better or worse than the usual approach for mantle cell lymphoma.
  • Baseline measurements and evaluations must be obtained within 42 days prior to randomization to the study. Abnormal PET or CT scans may constitute evaluable disease. Patient must have at least one objective measurable disease parameter by PET or CT. CT objectives measurable criteria includes measured dominant lesions are defined as nodes, nodal masses, and extranodal lesions that are clearly measurable in two diameters and PET objective measurable criteria includes an area of fludeoxyglucose F-18 (FDG) uptake as measured by standardized uptake value (SUV) and a Deauville score of 4 or 5. 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)

  • Patient must be age >= 18 years and =< 70 years of age

  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.

  • Patient must have untreated histologically confirmed mantle cell lymphoma, with cyclin D1 (BCL1) expression by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescence in situ hybridization (FISH) as confirmed by the enrolling center. If patient has cyclin D1 negative mantle cell lymphoma with classical morphology and an expression profile (including SOX11+) that is otherwise indistinguishable from mantle cell lymphoma, communication with investigator is required for consideration of enrollment. The diagnosis must be confirmed by formal hematopathology review at the enrolling center

  • Patients being treated with gastric reducing agent proton pump inhibitors must be switched to an alternative drug before starting acalabrutinib.

  • Absolute neutrophil count (ANC) >= 1,000/mcL (obtained within 14 days prior to randomization). If disease includes marrow involvement or hypersplenism, please reference the below revised ANC requirement: * ANC >= 500/mcL

  • Platelets >= 75,000 mcL (obtained within 14 days prior to 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 within 14 days prior to 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 within 14 days prior to 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) and activated partial thromboplastin time (aPTT) in the absence of lupus anticoagulant) < 2 x institutional ULN (obtained within 14 days prior to 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 study chair and discussion must be uploaded and documented on the baseline forms within Medidata Rave.

  • Creatinine =< institutional ULN, OR glomerular filtration rate (GFR) >= 40 mL/min/1.73 m^2 (obtained within 14 days prior to 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 patient with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Per the Centers for Disease Control (CDC), chronic is defined as (positive [+]) hepatitis B surface antigen (HepBsag), (+) hepatitis core antibody (HepBcab), (negative [-]) IgM hepatitis B core antibody (Hepbcab), and (-) hepatitis B surface antibody (HepBsab).

  • Patient 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.

  • Patient 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 study supplied regimen are eligible for this trial.

  • Patient 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.

  • 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 randomization, 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 defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) 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.

  • Patient is not eligible if he/she requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor.

  • Patient 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

  • Patient is 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 prior to 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.

  • Patient 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 (i.e. lymph node [LN] bone marrow core biopsy and aspiration [BM Bx], etc). is available for submission OR, * If tumor tissue is not available and patient has circulating mantle cells in the peripheral blood, then peripheral blood collected prior to initiation of protocol therapy may 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 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.

United States
AK
Anchorage
Alaska Breast Care and Surgery LLC
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Alaska Oncology and Hematology LLC
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Email: AKPAMC.OncologyResearchSupport@providence.org

Alaska Women's Cancer Care
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Email: AKPAMC.OncologyResearchSupport@providence.org

Anchorage Associates in Radiation Medicine
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Email: AKPAMC.OncologyResearchSupport@providence.org

Anchorage Oncology Centre
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Email: AKPAMC.OncologyResearchSupport@providence.org

Anchorage Radiation Therapy Center
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Email: AKPAMC.OncologyResearchSupport@providence.org

Katmai Oncology Group
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Providence Alaska Medical Center
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Fairbanks
Fairbanks Memorial Hospital
Contact: Site Public Contact
Email: Veronica.Stevenson@foundationhealth.org

AR
Ft. Smith
Mercy Hospital Fort Smith
Contact: Site Public Contact

Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

AZ
Phoenix
Cancer Center at Saint Joseph's
Contact: Site Public Contact
Email: CancerInstitute@DignityHealth.org

Tucson
Banner University Medical Center - Tucson
Contact: Site Public Contact
Email: UACC-NCTN@uacc.arizona.edu

University of Arizona Cancer Center-North Campus
Contact: Site Public Contact

CA
Anaheim
Kaiser Permanente-Anaheim
Contact: Site Public Contact
Email: clinical.trials@kp.org

Arroyo Grande
Mission Hope Medical Oncology - Arroyo Grande
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Email: ResearchInstituteInquiries@CommonSpirit.org

Baldwin Park
Kaiser Permanente-Baldwin Park
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Email: clinical.trials@kp.org

Bellflower
Kaiser Permanente-Bellflower
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Email: clinical.trials@kp.org

Burbank
Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Email: Najee.Boucher@providence.org

Fontana
Kaiser Permanente-Fontana
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Email: clinical.trials@kp.org

Harbor City
Kaiser Permanente - Harbor City
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Email: clinical.trials@kp.org

Irvine
Kaiser Permanente-Irvine
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Email: clinical.trials@kp.org

Los Angeles
Kaiser Permanente Los Angeles Medical Center
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Email: clinical.trials@kp.org

Kaiser Permanente West Los Angeles
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Email: clinical.trials@kp.org

Ontario
Kaiser Permanente-Ontario
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Email: clinical.trials@kp.org

Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
Contact: Site Public Contact
Email: ucstudy@uci.edu

Palm Springs
Desert Regional Medical Center
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Panorama City
Kaiser Permanente - Panorama City
Contact: Site Public Contact
Email: clinical.trials@kp.org

Riverside
Kaiser Permanente-Riverside
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Email: clinical.trials@kp.org

Sacramento
Mercy Cancer Center - Sacramento
Contact: Site Public Contact
Email: OncologyResearch@DignityHealth.org

San Diego
Kaiser Permanente-San Diego Mission
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Email: clinical.trials@kp.org

Kaiser Permanente-San Diego Zion
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Email: clinical.trials@kp.org

San Luis Obispo
Pacific Central Coast Health Center-San Luis Obispo
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Email: ResearchInstituteInquiries@CommonSpirit.org

San Marcos
Kaiser Permanente-San Marcos
Contact: Site Public Contact
Email: clinical.trials@kp.org

Santa Maria
Mission Hope Medical Oncology - Santa Maria
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Woodland
Woodland Memorial Hospital
Contact: Site Public Contact
Email: OncologyResearch@DignityHealth.org

Woodland Hills
Kaiser Permanente-Woodland Hills
Contact: Site Public Contact
Email: clinical.trials@kp.org

CO
Aurora
Rocky Mountain Cancer Centers-Aurora
Contact: Site Public Contact
Email: info@westernstatesncorp.org

The Medical Center of Aurora
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Email: info@westernstatesncorp.org

Boulder
Boulder Community Foothills Hospital
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Email: info@westernstatesncorp.org

Boulder Community Hospital
Contact: Site Public Contact
Email: jbloomfield@co-cancerresearch.org

Rocky Mountain Cancer Centers-Boulder
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Centennial
Rocky Mountain Cancer Centers - Centennial
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Colorado Springs
Penrose-Saint Francis Healthcare
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Rocky Mountain Cancer Centers-Penrose
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Saint Francis Cancer Center
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Denver
Cancer Center of Colorado at Sloan's Lake
Contact: Site Public Contact

Colorado Blood Cancer Institute
Contact: Site Public Contact
Email: info@westernstatesncorp.org

National Jewish Health-Main Campus
Contact: Site Public Contact
Email: glicht@co-cancerresearch.org

Porter Adventist Hospital
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Presbyterian - Saint Lukes Medical Center - Health One
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Rocky Mountain Cancer Centers-Midtown
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Email: info@westernstatesncorp.org

Rocky Mountain Cancer Centers-Rose
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Email: info@westernstatesncorp.org

Rose Medical Center
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Email: ccrp@co-cancerresearch.org

SCL Health Saint Joseph Hospital
Contact: Site Public Contact
Email: alan.franklin@sclhealth.org

The Women's Imaging Center
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Western Surgical Care
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Durango
Mercy Medical Center
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Southwest Oncology PC
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Englewood
Mountain Blue Cancer Care Center - Swedish
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Rocky Mountain Cancer Centers - Swedish
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Swedish Medical Center
Contact: Site Public Contact
Email: info@westernstatesncorp.org

The Melanoma and Skin Cancer Institute
Contact: Site Public Contact
Email: ryan.weight@theskincancerinstitute.com

Golden
National Jewish Health-Western Hematology Oncology
Contact: Site Public Contact
Email: glicht@co-cancerresearch.org

Grand Junction
Saint Mary's Hospital and Regional Medical Center
Contact: Site Public Contact
Email: ccrp@co-cancerresearch.org

Greeley
North Colorado Medical Center
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Lafayette
Good Samaritan Medical Center
Contact: Site Public Contact

Lakewood
Rocky Mountain Cancer Centers-Lakewood
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Saint Anthony Hospital
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Littleton
Littleton Adventist Hospital
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Rocky Mountain Cancer Centers-Littleton
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Lone Tree
Rocky Mountain Cancer Centers-Sky Ridge
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Sky Ridge Medical Center
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Longmont
Longmont United Hospital
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Rocky Mountain Cancer Centers-Longmont
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Loveland
McKee Medical Center
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Parker
Parker Adventist Hospital
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Pueblo
Saint Mary Corwin Medical Center
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Thornton
National Jewish Health-Northern Hematology Oncology
Contact: Site Public Contact
Email: glicht@co-cancerresearch.org

Rocky Mountain Cancer Centers-Thornton
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Wheat Ridge
SCL Health Lutheran Medical Center
Contact: Site Public Contact
Email: ccrp@co-cancerresearch.org

DC
Washington
Sibley Memorial Hospital
Contact: Site Public Contact
Email: jquiver1@jhmi.edu

FL
Jacksonville
Mayo Clinic in Florida
Contact: Site Public Contact

GA
Atlanta
Emory Saint Joseph's Hospital
Contact: Site Public Contact

Emory University Hospital Midtown
Contact: Site Public Contact

Emory University Hospital/Winship Cancer Institute
Contact: Site Public Contact

IA
Ames
Mary Greeley Medical Center
Contact: Site Public Contact

McFarland Clinic PC - Ames
Contact: Site Public Contact
Email: ksoder@mcfarlandclinic.com

Boone
McFarland Clinic PC-Boone
Contact: Site Public Contact

Carroll
Saint Anthony Regional Hospital
Contact: Site Public Contact
Email: sbenson@iora.org

Clive
Medical Oncology and Hematology Associates-West Des Moines
Contact: Site Public Contact

Mercy Cancer Center-West Lakes
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Council Bluffs
Alegent Health Mercy Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Creston
Greater Regional Medical Center
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Des Moines
Broadlawns Medical Center
Contact: Site Public Contact

Iowa Lutheran Hospital
Contact: Site Public Contact

Iowa Methodist Medical Center
Contact: Site Public Contact

Medical Oncology and Hematology Associates-Des Moines
Contact: Site Public Contact

Mercy Medical Center - Des Moines
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Mission Cancer and Blood - Laurel
Contact: Site Public Contact

Fort Dodge
McFarland Clinic PC-Trinity Cancer Center
Contact: Site Public Contact

Trinity Regional Medical Center
Contact: Site Public Contact

Jefferson
McFarland Clinic PC-Jefferson
Contact: Site Public Contact

Marshalltown
McFarland Clinic PC-Marshalltown
Contact: Site Public Contact

West Des Moines
Mercy Medical Center-West Lakes
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Methodist West Hospital
Contact: Site Public Contact

ID
Boise
Saint Alphonsus Cancer Care Center-Boise
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Saint Luke's Cancer Institute - Boise
Contact: Site Public Contact
Email: eslinget@slhs.org

Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Coeur D'Alene
Kootenai Health - Coeur d'Alene
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Emmett
Walter Knox Memorial Hospital
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Fruitland
Saint Luke's Cancer Institute - Fruitland
Contact: Site Public Contact
Email: eslinget@slhs.org

Meridian
Idaho Urologic Institute-Meridian
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Saint Luke's Cancer Institute - Meridian
Contact: Site Public Contact
Email: eslinget@slhs.org

Nampa
Saint Alphonsus Medical Center-Nampa
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Saint Luke's Cancer Institute - Nampa
Contact: Site Public Contact
Email: eslinget@slhs.org

Post Falls
Kootenai Clinic Cancer Services - Post Falls
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Sandpoint
Kootenai Cancer Clinic
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Twin Falls
Saint Luke's Cancer Institute - Twin Falls
Contact: Site Public Contact
Email: eslinget@slhs.org

IL
Alton
Saint Anthony's Health
Contact: Site Public Contact

Aurora
Rush - Copley Medical Center
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com

Barrington
Advocate Good Shepherd Hospital
Contact: Site Public Contact

Bloomington
Illinois CancerCare-Bloomington
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Burr Ridge
Loyola Center for Health at Burr Ridge
Contact: Site Public Contact

Canton
Illinois CancerCare-Canton
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Carbondale
Memorial Hospital of Carbondale
Contact: Site Public Contact
Email: clinical.research@sih.net

Carterville
SIH Cancer Institute
Contact: Site Public Contact
Email: clinical.research@sih.net

Carthage
Illinois CancerCare-Carthage
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Centralia
Centralia Oncology Clinic
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Chicago
Advocate Illinois Masonic Medical Center
Contact: Site Public Contact

John H Stroger Jr Hospital of Cook County
Contact: Site Public Contact

Northwestern University
Contact: Site Public Contact
Email: cancer@northwestern.edu

University of Chicago Comprehensive Cancer Center
Contact: Site Public Contact
Email: cancerclinicaltrials@bsd.uchicago.edu

Crystal Lake
AMG Crystal Lake - Oncology
Contact: Site Public Contact
Email: advocateresearch@advocate.com

Danville
Carle on Vermilion
Contact: Site Public Contact
Email: Research@carle.com

DeKalb
Northwestern Medicine Cancer Center Kishwaukee
Contact: Site Public Contact
Email: Donald.Smith3@nm.org

Decatur
Cancer Care Specialists of Illinois - Decatur
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Dixon
Illinois CancerCare-Dixon
Contact: Site Public Contact

Downers Grove
Advocate Good Samaritan Hospital
Contact: Site Public Contact
Email: Barbara.barhamand@advocatehealth.com

Effingham
Carle Physician Group-Effingham
Contact: Site Public Contact
Email: Research@carle.com

Crossroads Cancer Center
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Elgin
Advocate Sherman Hospital
Contact: Site Public Contact

Eureka
Illinois CancerCare-Eureka
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Evanston
NorthShore University HealthSystem-Evanston Hospital
Contact: Site Public Contact

Galesburg
Illinois CancerCare-Galesburg
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Western Illinois Cancer Treatment Center
Contact: Site Public Contact

Geneva
Northwestern Medicine Cancer Center Delnor
Contact: Site Public Contact
Email: Donald.Smith3@nm.org

Glenview
NorthShore University HealthSystem-Glenbrook Hospital
Contact: Site Public Contact

Harvey
Ingalls Memorial Hospital
Contact: Site Public Contact
Email: clinicaltrials@ingalls.org

Hazel Crest
Advocate South Suburban Hospital
Contact: Site Public Contact

Highland Park
NorthShore University HealthSystem-Highland Park Hospital
Contact: Site Public Contact

Homer Glen
Loyola Medicine Homer Glen
Contact: Site Public Contact

Kewanee
Illinois CancerCare-Kewanee Clinic
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Lake Forest
Northwestern Medicine Lake Forest Hospital
Contact: Site Public Contact
Email: cancertrials@northwestern.edu

Libertyville
AMG Libertyville - Oncology
Contact: Site Public Contact
Email: advocateresearch@advocatehealth.com

Condell Memorial Hospital
Contact: Site Public Contact
Email: advocateresearch@advocatehealth.com

Macomb
Illinois CancerCare-Macomb
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Mattoon
Carle Physician Group-Mattoon/Charleston
Contact: Site Public Contact
Email: Research@carle.com

Maywood
Loyola University Medical Center
Contact: Site Public Contact

Melrose Park
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Contact: Site Public Contact

Mount Vernon
Good Samaritan Regional Health Center
Contact: Site Public Contact

New Lenox
UC Comprehensive Cancer Center at Silver Cross
Contact: Site Public Contact
Email: cancerclinicaltrials@bsd.uchicago.edu

O'Fallon
Cancer Care Center of O'Fallon
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Oak Lawn
Advocate Christ Medical Center
Contact: Site Public Contact

Orland Park
University of Chicago Medicine-Orland Park
Contact: Site Public Contact
Email: cancerclinicaltrials@bsd.uchicago.edu

Ottawa
Illinois CancerCare-Ottawa Clinic
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Park Ridge
Advocate Lutheran General Hospital
Contact: Site Public Contact

Pekin
Illinois CancerCare-Pekin
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peoria
Illinois CancerCare-Peoria
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Methodist Medical Center of Illinois
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

OSF Saint Francis Medical Center
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peru
Illinois CancerCare-Peru
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Valley Radiation Oncology
Contact: Site Public Contact

Princeton
Illinois CancerCare-Princeton
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Springfield
Memorial Medical Center
Contact: Site Public Contact
Email: pallante.beth@mhsil.com

Southern Illinois University School of Medicine
Contact: Site Public Contact

Springfield Clinic
Contact: Site Public Contact

Swansea
Southwest Illinois Health Services LLP
Contact: Site Public Contact
Email: lynns@thecancercenter.com

Urbana
Carle Cancer Center
Contact: Site Public Contact
Email: Research@carle.com

The Carle Foundation Hospital
Contact: Site Public Contact
Email: Research@carle.com

Warrenville
Northwestern Medicine Cancer Center Warrenville
Contact: Site Public Contact
Email: Donald.Smith3@nm.org

Washington
Illinois CancerCare - Washington
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Yorkville
Rush-Copley Healthcare Center
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com

KS
Garden City
Central Care Cancer Center - Garden City
Contact: Site Public Contact
Email: aroland@kccop.org

Great Bend
Central Care Cancer Center - Great Bend
Contact: Site Public Contact
Email: aroland@kccop.org

Hays
HaysMed University of Kansas Health System
Contact: Site Public Contact

Kansas City
University of Kansas Cancer Center
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

Lawrence
Lawrence Memorial Hospital
Contact: Site Public Contact
Email: Stephanie.Norris@LMH.ORG

Olathe
Olathe Health Cancer Center
Contact: Site Public Contact
Email: Jeni.wakefield@olathehealth.org

Overland Park
University of Kansas Cancer Center-Overland Park
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

Pittsburg
Ascension Via Christi - Pittsburg
Contact: Site Public Contact
Email: jennifer.jameson@ascension.org

Salina
Salina Regional Health Center
Contact: Site Public Contact
Email: mleepers@srhc.com

Topeka
Cotton O'Neil Cancer Center / Stormont Vail Health
Contact: Site Public Contact

University of Kansas Health System Saint Francis Campus
Contact: Site Public Contact

Westwood
University of Kansas Hospital-Westwood Cancer Center
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

KY
Bardstown
Flaget Memorial Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Corbin
Commonwealth Cancer Center-Corbin
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Lexington
Saint Joseph Hospital
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Saint Joseph Hospital East
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph Radiation Oncology Resource Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

London
Saint Joseph London
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Louisville
Jewish Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Saints Mary and Elizabeth Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

UofL Health Medical Center Northeast
Contact: Site Public Contact
Email: ctoinfo@louisville.edu

Mount Sterling
Saint Joseph Mount Sterling
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Shepherdsville
Jewish Hospital Medical Center South
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

LA
Monroe
Ochsner LSU Health Monroe Medical Center
Contact: Site Public Contact
Email: LPost@lsuhsc.edu

New Orleans
Ochsner Medical Center Jefferson
Contact: Site Public Contact
Email: Elisemarie.curry@ochsner.org

Shreveport
LSU Health Sciences Center at Shreveport
Contact: Site Public Contact
Email: LPost@lsuhsc.edu

MA
Worcester
UMass Memorial Medical Center - University Campus
Contact: Site Public Contact
Email: cancer.research@umassmed.edu

MD
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Contact: Site Public Contact
Email: jhcccro@jhmi.edu

ME
Bangor
Eastern Maine Medical Center
Contact: Site Public Contact

Brewer
Lafayette Family Cancer Center-EMMC
Contact: Site Public Contact

MI
Adrian
Hickman Cancer Center
Contact: Site Public Contact

Ann Arbor
University of Michigan Comprehensive Cancer Center
Contact: Site Public Contact

Battle Creek
Bronson Battle Creek
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Detroit
Wayne State University/Karmanos Cancer Institute
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Farmington Hills
Weisberg Cancer Treatment Center
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Spectrum Health at Butterworth Campus
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Trinity Health Grand Rapids Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Kalamazoo
Ascension Borgess Cancer Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Borgess Medical Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Bronson Methodist Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

West Michigan Cancer Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Monroe
Toledo Clinic Cancer Centers-Monroe
Contact: Site Public Contact

Muskegon
Trinity Health Muskegon Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Niles
Lakeland Hospital Niles
Contact: Site Public Contact

Norton Shores
Cancer and Hematology Centers of Western Michigan - Norton Shores
Contact: Site Public Contact
Email: connie.szczepanek@crcwm.org

Reed City
Spectrum Health Reed City Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Saint Joseph
Lakeland Medical Center Saint Joseph
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Marie Yeager Cancer Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Traverse City
Munson Medical Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Wyoming
Metro Health Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

MN
Aitkin
Riverwood Healthcare Center
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Baxter
Essentia Health - Baxter Clinic
Contact: Site Public Contact

Bemidji
Sanford Joe Lueken Cancer Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Brainerd
Essentia Health Saint Joseph's Medical Center
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Burnsville
Fairview Ridges Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Minnesota Oncology - Burnsville
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Cambridge
Cambridge Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Coon Rapids
Mercy Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Deer River
Essentia Health - Deer River Clinic
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Detroit Lakes
Essentia Health Saint Mary's - Detroit Lakes Clinic
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Duluth
Essentia Health Cancer Center
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Essentia Health Saint Mary's Medical Center
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Miller-Dwan Hospital
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Edina
Fairview Southdale Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Ely
Essentia Health - Ely Clinic
Contact: Site Public Contact

Fergus Falls
Lake Region Healthcare Corporation-Cancer Care
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Fosston
Essentia Health - Fosston
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Fridley
Unity Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Hibbing
Essentia Health Hibbing Clinic
Contact: Site Public Contact

International Falls
Essentia Health - International Falls Clinic
Contact: Site Public Contact

Maple Grove
Fairview Clinics and Surgery Center Maple Grove
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Maplewood
Minnesota Oncology Hematology PA-Maplewood
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint John's Hospital - Healtheast
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Minneapolis
Abbott-Northwestern Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Health Partners Inc
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Hennepin County Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Monticello
Monticello Cancer Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Moose Lake
Essentia Health - Moose Lake Clinic
Contact: Site Public Contact

New Ulm
New Ulm Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Park Rapids
Essentia Health - Park Rapids
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Princeton
Fairview Northland Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Robbinsdale
North Memorial Medical Health Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Rochester
Mayo Clinic in Rochester
Contact: Site Public Contact

Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint Paul
Regions Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

United Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Sandstone
Essentia Health Sandstone
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Shakopee
Saint Francis Regional Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Stillwater
Lakeview Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Thief River Falls
Sanford Thief River Falls Medical Center
Contact: Site Public Contact

Virginia
Essentia Health Virginia Clinic
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Waconia
Ridgeview Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Willmar
Rice Memorial Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Woodbury
Minnesota Oncology Hematology PA-Woodbury
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Worthington
Sanford Cancer Center Worthington
Contact: Site Public Contact

Wyoming
Fairview Lakes Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

MO
Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Contact: Site Public Contact

Bolivar
Central Care Cancer Center - Bolivar
Contact: Site Public Contact
Email: aroland@kccop.org

Bonne Terre
Parkland Health Center-Bonne Terre
Contact: Site Public Contact

Branson
Cox Cancer Center Branson
Contact: Site Public Contact

Cape Girardeau
Saint Francis Medical Center
Contact: Site Public Contact
Email: sfmc@sfmc.net

Southeast Cancer Center
Contact: Site Public Contact

Chesterfield
Saint Luke's Hospital
Contact: Site Public Contact

Creve Coeur
Siteman Cancer Center at West County Hospital
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Farmington
Parkland Health Center - Farmington
Contact: Site Public Contact

Jefferson City
Capital Region Southwest Campus
Contact: Site Public Contact
Email: swooden@mail.crmc.org

Joplin
Freeman Health System
Contact: Site Public Contact
Email: LJCrockett@freemanhealth.com

Mercy Hospital Joplin
Contact: Site Public Contact
Email: esmeralda.carrillo@mercy.net

Kansas City
Truman Medical Centers
Contact: Site Public Contact

University of Kansas Cancer Center - North
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

Lee's Summit
University of Kansas Cancer Center - Lee's Summit
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

Rolla
Delbert Day Cancer Institute at PCRMC
Contact: Site Public Contact
Email: research@phelpshealth.org

Mercy Clinic-Rolla-Cancer and Hematology
Contact: Site Public Contact

Saint Joseph
Heartland Regional Medical Center
Contact: Site Public Contact
Email: linda.schumacher@mymlc.com

Saint Louis
Mercy Hospital Saint Louis
Contact: Site Public Contact

Mercy Hospital South
Contact: Site Public Contact
Email: janet.lesko@mercy.net

Missouri Baptist Medical Center
Contact: Site Public Contact

Saint Louis Cancer and Breast Institute-South City
Contact: Site Public Contact

Siteman Cancer Center at Christian Hospital
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Siteman Cancer Center-South County
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Washington University School of Medicine
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Contact: Site Public Contact

Springfield
CoxHealth South Hospital
Contact: Site Public Contact

Mercy Hospital Springfield
Contact: Site Public Contact

Sullivan
Missouri Baptist Sullivan Hospital
Contact: Site Public Contact

Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Contact: Site Public Contact

Washington
Mercy Hospital Washington
Contact: Site Public Contact

MT
Anaconda
Community Hospital of Anaconda
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Billings
Billings Clinic Cancer Center
Contact: Site Public Contact
Email: research@billingsclinic.org

Saint Vincent Frontier Cancer Center
Contact: Site Public Contact

Saint Vincent Healthcare
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Bozeman
Bozeman Deaconess Hospital
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Butte
Saint James Community Hospital and Cancer Treatment Center
Contact: Site Public Contact

Great Falls
Benefis Healthcare- Sletten Cancer Institute
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Great Falls Clinic
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Kalispell
Kalispell Regional Medical Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Missoula
Community Medical Hospital
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Saint Patrick Hospital - Community Hospital
Contact: Site Public Contact
Email: amy.hanneman@providence.org

NC
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Contact: Site Public Contact
Email: cancerclinicaltrials@med.unc.edu

Clinton
Southeastern Medical Oncology Center-Clinton
Contact: Site Public Contact
Email: jfields@cancersmoc.com

Goldsboro
Southeastern Medical Oncology Center-Goldsboro
Contact: Site Public Contact
Email: jfields@cancersmoc.com

Jacksonville
Southeastern Medical Oncology Center-Jacksonville
Contact: Site Public Contact
Email: jfields@cancersmoc.com

Kenansville
Vidant Oncology-Kenansville
Contact: Site Public Contact
Email: Carla.Zimmerman@vidanthealth.com

Kinston
Vidant Oncology-Kinston
Contact: Site Public Contact
Email: Carla.Zimmerman@vidanthealth.com

Richlands
Vidant Oncology-Richlands
Contact: Site Public Contact
Email: Carla.Zimmerman@vidanthealth.com

ND
Bismarck
Sanford Bismarck Medical Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Fargo
Essentia Health Cancer Center-South University Clinic
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Sanford Broadway Medical Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Medical Center Fargo
Contact: Site Public Contact

Sanford Roger Maris Cancer Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford South University Medical Center
Contact: Site Public Contact

Southpointe-Sanford Medical Center Fargo
Contact: Site Public Contact

Jamestown
Essentia Health - Jamestown Clinic
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

NE
Grand Island
CHI Health Saint Francis
Contact: Site Public Contact

Kearney
CHI Health Good Samaritan
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Lincoln
Saint Elizabeth Regional Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Omaha
Alegent Health Bergan Mercy Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Immanuel Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Lakeside Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Creighton University Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Nebraska Medicine-Village Pointe
Contact: Site Public Contact

University of Nebraska Medical Center
Contact: Site Public Contact
Email: unmcrsa@unmc.edu

Papillion
Midlands Community Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

NH
Lebanon
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Contact: Site Public Contact
Email: cancer.research.nurse@dartmouth.edu

NJ
Morristown
Morristown Medical Center
Contact: Site Public Contact

Summit
Overlook Hospital
Contact: Site Public Contact

NY
Buffalo
Roswell Park Cancer Institute
Contact: Site Public Contact
Email: askroswell@roswellpark.org

Glens Falls
Glens Falls Hospital
Contact: Site Public Contact

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Contact: Site Public Contact
Email: CancerTrials@nyulangone.org

NYP/Weill Cornell Medical Center
Contact: Site Public Contact

Rochester
University of Rochester
Contact: Site Public Contact

OH
Cincinnati
Bethesda North Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Good Samaritan Hospital - Cincinnati
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

TriHealth Cancer Institute-Anderson
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

TriHealth Cancer Institute-Westside
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

University of Cincinnati Cancer Center-UC Medical Center
Contact: Site Public Contact
Email: cancer@uchealth.com

Cleveland
Case Western Reserve University
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.org

Cleveland Clinic Foundation
Contact: Site Public Contact
Email: TaussigResearch@ccf.org

MetroHealth Medical Center
Contact: Site Public Contact
Email: dstrater@metrohealth.org

Columbus
Ohio State University Comprehensive Cancer Center
Contact: Site Public Contact
Email: Jamesline@osumc.edu

Perrysburg
Mercy Health Perrysburg Cancer Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

Sylvania
ProMedica Flower Hospital
Contact: Site Public Contact
Email: PCIOncResearch@promedica.org

Toledo
Mercy Health - Saint Anne Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Contact: Site Public Contact
Email: PCIOncResearch@promedica.org

Toledo Clinic Cancer Centers-Toledo
Contact: Site Public Contact

West Chester
University of Cincinnati Cancer Center-West Chester
Contact: Site Public Contact
Email: cancer@uchealth.com

OK
Oklahoma City
Mercy Hospital Oklahoma City
Contact: Site Public Contact

University of Oklahoma Health Sciences Center
Contact: Site Public Contact
Email: ou-clinical-trials@ouhsc.edu

OR
Baker City
Saint Alphonsus Medical Center-Baker City
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Bend
Saint Charles Health System
Contact: Site Public Contact
Email: nosall@stcharleshealthcare.org

Clackamas
Clackamas Radiation Oncology Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Cancer Institute Clackamas Clinic
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Coos Bay
Bay Area Hospital
Contact: Site Public Contact
Email: cherie.cox@bayareahospital.org

Newberg
Providence Newberg Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Ontario
Saint Alphonsus Medical Center-Ontario
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Portland
Oregon Health and Science University
Contact: Site Public Contact
Email: trials@ohsu.edu

Providence Portland Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Redmond
Saint Charles Health System-Redmond
Contact: Site Public Contact

RI
Providence
Rhode Island Hospital
Contact: Site Public Contact

SC
Boiling Springs
Prisma Health Cancer Institute - Spartanburg
Contact: Site Public Contact

Charleston
Medical University of South Carolina
Contact: Site Public Contact
Email: hcc-clinical-trials@musc.edu

Easley
Prisma Health Cancer Institute - Easley
Contact: Site Public Contact
Email: Kim.Williams3@prismahealth.org

Greenville
Prisma Health Cancer Institute - Butternut
Contact: Site Public Contact

Prisma Health Cancer Institute - Eastside
Contact: Site Public Contact

Prisma Health Cancer Institute - Faris
Contact: Site Public Contact

Greer
Prisma Health Cancer Institute - Greer
Contact: Site Public Contact

Seneca
Prisma Health Cancer Institute - Seneca
Contact: Site Public Contact

SD
Sioux Falls
Avera Cancer Institute
Contact: Site Public Contact
Email: OncRegulatory@avera.org

Sanford Cancer Center Oncology Clinic
Contact: Site Public Contact
Email: OncologyClinicTrialsSF@sanfordhealth.org

Sanford USD Medical Center - Sioux Falls
Contact: Site Public Contact
Email: OncologyClinicalTrialsSF@SanfordHealth.org

TX
Bryan
Saint Joseph Regional Cancer Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

UT
American Fork
American Fork Hospital / Huntsman Intermountain Cancer Center
Contact: Site Public Contact
Email: officeofresearch@imail.org

Cedar City
Sandra L Maxwell Cancer Center
Contact: Site Public Contact
Email: officeofresearch@imail.org

Logan
Logan Regional Hospital
Contact: Site Public Contact
Email: officeofresearch@imail.org

Murray
Intermountain Medical Center
Contact: Site Public Contact
Email: officeofresearch@imail.org

Ogden
McKay-Dee Hospital Center
Contact: Site Public Contact
Email: officeofresearch@imail.org

Provo
Utah Valley Regional Medical Center
Contact: Site Public Contact
Email: officeofresearch@imail.org

Riverton
Riverton Hospital
Contact: Site Public Contact
Email: officeofresearch@imail.org

Saint George
Saint George Regional Medical Center
Contact: Site Public Contact
Email: officeofresearch@imail.org

Salt Lake City
Huntsman Cancer Institute/University of Utah
Contact: Site Public Contact
Email: cancerinfo@hci.utah.edu

LDS Hospital
Contact: Site Public Contact
Email: officeofresearch@imail.org

Utah Cancer Specialists-Salt Lake City
Contact: Site Public Contact
Email: officeofresearch@imail.org

VA
Charlottesville
University of Virginia Cancer Center
Contact: Site Public Contact
Email: uvacancertrials@hscmail.mcc.virginia.edu

Richmond
Virginia Commonwealth University/Massey Cancer Center
Contact: Site Public Contact
Email: CTOclinops@vcu.edu

VT
Berlin
Central Vermont Medical Center/National Life Cancer Treatment
Contact: Site Public Contact

Burlington
University of Vermont Medical Center
Contact: Site Public Contact
Email: rpo@uvm.edu

University of Vermont and State Agricultural College
Contact: Site Public Contact
Email: rpo@uvm.edu

Saint Johnsbury
Norris Cotton Cancer Center-North
Contact: Site Public Contact
Email: cancer.research.nurse@hitchcock.org

WI
Antigo
Langlade Hospital and Cancer Center
Contact: Site Public Contact
Email: Juli.Alford@aspirus.org

Appleton
ThedaCare Regional Cancer Center
Contact: Site Public Contact
Email: ResearchDept@thedacare.org

Ashland
Duluth Clinic Ashland
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Northwest Wisconsin Cancer Center
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Burlington
Aurora Cancer Care-Southern Lakes VLCC
Contact: Site Public Contact
Email: ncorp@aurora.org

Cudahy
Aurora Saint Luke's South Shore
Contact: Site Public Contact
Email: ncorp@aurora.org

Eau Claire
Marshfield Medical Center-EC Cancer Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Fond Du Lac
Aurora Health Center-Fond du Lac
Contact: Site Public Contact
Email: ncorp@aurora.org

Germantown
Aurora Health Care Germantown Health Center
Contact: Site Public Contact
Email: ncorp@aurora.org

Grafton
Aurora Cancer Care-Grafton
Contact: Site Public Contact
Email: ncorp@aurora.org

Green Bay
Aurora BayCare Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org

Bellin Memorial Hospital
Contact: Site Public Contact

Saint Vincent Hospital Cancer Center Green Bay
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

Saint Vincent Hospital Cancer Center at Saint Mary's
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

Hayward
Essentia Health-Hayward Clinic
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Kenosha
Aurora Cancer Care-Kenosha South
Contact: Site Public Contact
Email: ncorp@aurora.org

La Crosse
Gundersen Lutheran Medical Center
Contact: Site Public Contact
Email: cancerctr@gundersenhealth.org

Madison
University of Wisconsin Carbone Cancer Center
Contact: Site Public Contact

Marinette
Aurora Bay Area Medical Group-Marinette
Contact: Site Public Contact
Email: ncorp@aurora.org

Marshfield
Marshfield Medical Center-Marshfield
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Medford
Aspirus Medford Hospital
Contact: Site Public Contact
Email: Beth.Knetter@aspirus.org

Milwaukee
Aurora Cancer Care-Milwaukee
Contact: Site Public Contact
Email: ncorp@aurora.org

Aurora Saint Luke's Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org

Aurora Sinai Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org

Medical College of Wisconsin
Contact: Site Public Contact

Minocqua
Marshfield Clinic-Minocqua Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Mukwonago
ProHealth D N Greenwald Center
Contact: Site Public Contact
Email: research.institute@phci.org

New Richmond
Cancer Center of Western Wisconsin
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Contact: Site Public Contact

Oconto Falls
Saint Vincent Hospital Cancer Center at Oconto Falls
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Contact: Site Public Contact
Email: ncorp@aurora.org

Racine
Aurora Cancer Care-Racine
Contact: Site Public Contact
Email: ncorp@aurora.org

Rice Lake
Marshfield Medical Center-Rice Lake
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Contact: Site Public Contact
Email: ncorp@aurora.org

Spooner
Essentia Health-Spooner Clinic
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Stevens Point
Ascension Saint Michael's Hospital
Contact: Site Public Contact
Email: Beth.Knetter@aspirus.org

Marshfield Medical Center-River Region at Stevens Point
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Sturgeon Bay
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

Summit
Aurora Medical Center in Summit
Contact: Site Public Contact
Email: ncorp@aurora.org

Superior
Essentia Health Saint Mary's Hospital - Superior
Contact: Site Public Contact

Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Contact: Site Public Contact
Email: ncorp@aurora.org

Waukesha
ProHealth Waukesha Memorial Hospital
Contact: Site Public Contact

UW Cancer Center at ProHealth Care
Contact: Site Public Contact
Email: Chanda.miller@phci.org

Wausau
Aspirus Regional Cancer Center
Contact: Site Public Contact

Wauwatosa
Aurora Cancer Care-Milwaukee West
Contact: Site Public Contact
Email: ncorp@aurora.org

West Allis
Aurora West Allis Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org

Weston
Marshfield Medical Center - Weston
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Wisconsin Rapids
Aspirus Cancer Care - Wisconsin Rapids
Contact: Site Public Contact

WY
Cheyenne
Cheyenne Regional Medical Center-West
Contact: Site Public Contact
Email: ccrp@co-cancerresearch.org

Cody
Billings Clinic-Cody
Contact: Site Public Contact
Email: research@billingsclinic.org

Sheridan
Welch Cancer Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

PRIMARY OBJECTIVE:
I. Positron mission tomography (PET)/computed tomography (CT) complete response (CR)/peripheral blood minimal residual disease (MRD) negative rate.

SECONDARY OBJECTIVES:
I. Progression-free survival at 36 months.
II. Toxicity rates (incidence of grade 3/4 infections, renal and neurologic toxicities, cumulative dose of cytarabine & acalabrutinib, dose reduction, and treatment discontinuation due to toxicity).
III. Objective response rate (ORR).
IV. Overall survival at 36 months.
V. Mobilization failure rate (defined as a yield < 2 x 10^6 CD34+ stem cells/kg with a maximum of 4 courses of apheresis).
VI. To compare PET/CT negative rate between the three arms.
VII. To evaluate the association between baseline PET quantitative assessment (qPET) and MRD status at end of treatment (EOT).
VIII. To evaluate the association between the change of qPET parameters from baseline to EOT and MRD, and compare this association across all 3 arms.
IX. To determine the incremental prognostic value of baseline qPET to standard risk markers (Mantle Cell Lymphoma International Prognostic Index [MIPI]) in predicting MRD status at EOT.
X. To determine the prognostic value of baseline, interim and EOT PET in predicting progression-free survival (PFS).

EXPLORATORY IMAGING OBJECTIVES:
I. Interim PET status both qualitatively (Deauville) and quantitatively will be correlated with MRD status at EOT (end of induction).
II. Explore the incremental prognostic value of interim qPET to standard risk markers (MIPI) in predicting MRD status at EOT.
III. Explore the incremental prognostic value of interim qPET to Ki67 in predicting MRD status at EOT.
IV. Explore the association of interim and EOT PET with overall survival (OS).

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM A: Patients receive bendamustine hydrochloride intravenously (IV) on days 1 and 2 and rituximab IV or rituximab and hyaluronidase human subcutaneously (SC) 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 or rituximab and hyaluronidase human SC on day 1 and cytarabine IV every 12 hours (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.

ARM B: Patients receive acalabrutinib orally (PO) twice daily (BID) on days 1-28, bendamustine hydrochloride IV on days 1 and 2, and rituximab IV or rituximab and hyaluronidase human SC 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 or rituximab and hyaluronidase human SC 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.

ARM C: Patients receive acalabrutinib PO BID on days 1-28, bendamustine hydrochloride IV on days 1 and 2, and rituximab IV or rituximab and hyaluronidase human SC on day 1 or 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Patients in all arms undergo PET/CT scans throughout the trial, CT scans during follow up, and collection of blood samples throughout the trial.

After completion of study treatment, patients are followed up every 2-3 months for years 1-3, and then every 6 months for years 4-5, and then annually until year 10.

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network.


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