Rituximab and Combination Chemotherapy with or without Lenalidomide in Treating Patients with Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IIBiomarker/Laboratory analysis, TreatmentActive18 and overE1412
NCI-2013-00959, ECOG-E1412, NCT01856192

Trial Description

Summary

This randomized phase II trial studies how well rituximab and combination chemotherapy with or without lenalidomide work in treating patients with newly diagnosed stage II-IV diffuse large B cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, 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. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether rituximab and combination chemotherapy are more effective when given with or without lenalidomide in treating patients with diffuse large B cell lymphoma.

Further Study Information

PRIMARY OBJECTIVES:

I. Progression-free survival (PFS).

SECONDARY OBJECTIVES:

I. Response rate (RR).

II. Complete remission (CR) rate as defined by positron emission tomography (PET)-computed tomography (CT) criteria.

III. Overall survival (OS).

TERTIARY OBJECTIVES:

I. Impact of diffuse large B cell lymphoma (DLBCL) molecular subtype on outcome.

II. Interim PET scan results in relation to treatment outcome.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive rituximab intravenously (IV), cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1; prednisone orally (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.

ARM B: 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.

After completion of study treatment, patient are followed up every 3 months for 2 years, every 6 months for 1 year, and then annually for up to 7 years.

Eligibility Criteria

Inclusion Criteria:

PRE-REGISTRATION (STEP 0)

Histologically confirmed DLBCL expressing cluster of differentiation (CD)20 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 v-myc myelocytomatosis viral oncogene homolog (avian) (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: exisional 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 (erythropoietin [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

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

National Cancer Institute

  • National Cancer Institute
Grzegorz S. Nowakowski, Principal Investigator

Trial Sites

U.S.A.

Alaska
Anchorage

Alaska Breast Care and Surgery LLC

Keith S. Lanier
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Keith S. Lanier
Principal Investigator

Alaska Women's Cancer Care

Keith S. Lanier
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Keith S. Lanier
Principal Investigator

Anchorage Oncology Centre

Keith S. Lanier
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Keith S. Lanier
Principal Investigator

Katmai Oncology Group

Keith S. Lanier
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Keith S. Lanier
Principal Investigator

Providence Alaska Medical Center

Keith S. Lanier
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Keith S. Lanier
Principal Investigator

Arizona
Scottsdale

Mayo Clinic in Arizona

Grzegorz S. Nowakowski
Ph: 855-776-0015
Email: nowakowski.grzegorz@mayo.edu

Grzegorz S. Nowakowski
Principal Investigator

Arkansas
Little Rock

Veteran's Administration Medical Center

Zhifu Xiang
Ph: 501-686-8274

Zhifu Xiang
Principal Investigator

California
Burbank

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Keith S. Lanier
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Keith S. Lanier
Principal Investigator

Colorado
Denver

Colorado Cancer Research Program NCORP

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Florida
Lakeland

The Watson Clinic

Galina Vugman
Ph: 863-603-4720
Email: gvugman@watsonclinic.com

Galina Vugman
Principal Investigator

Georgia
Atlanta

Northside Hospital

Lijo Simpson
Ph: 404-501-3279

Lijo Simpson
Principal Investigator

Lawrenceville

Gwinnett Medical Center

Aldemar Montero
Ph: 678-312-2666

Aldemar Montero
Principal Investigator

Macon

Medical Center of Central Georgia

Frederick M. Schnell
Ph: 478-633-1226

Frederick M. Schnell
Principal Investigator

Hawaii
Honolulu

Oncare Hawaii Inc-POB II

Jeffrey L. Berenberg
Ph: 808-586-2979
Email: Jeffrey.l.Berenberg.civ@mail.mil

Jeffrey L. Berenberg
Principal Investigator

OnCare Hawaii-Kuakini

Jeffrey L. Berenberg
Ph: 808-586-2979
Email: Jeffrey.l.Berenberg.civ@mail.mil

Jeffrey L. Berenberg
Principal Investigator

Straub Clinic and Hospital

Jeffrey L. Berenberg
Ph: 808-586-2979
Email: Jeffrey.l.Berenberg.civ@mail.mil

Jeffrey L. Berenberg
Principal Investigator

The Cancer Center of Hawaii-Liliha

Jeffrey L. Berenberg
Ph: 808-586-2979
Email: Jeffrey.l.Berenberg.civ@mail.mil

Jeffrey L. Berenberg
Principal Investigator

University of Hawaii Cancer Center

Jeffrey L. Berenberg
Ph: 808-586-2979
Email: Jeffrey.l.Berenberg.civ@mail.mil

Jeffrey L. Berenberg
Principal Investigator

Idaho
Boise

Saint Alphonsus Cancer Care Center-Boise

Christopher M. Reynolds
Ph: 734-712-4673
Email: christopher_reynolds@ihacares.com

Christopher M. Reynolds
Principal Investigator

Saint Luke's Mountain States Tumor Institute

Keith S. Lanier
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Keith S. Lanier
Principal Investigator

Fruitland

Saint Luke's Mountain States Tumor Institute - Fruitland

Keith S. Lanier
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Keith S. Lanier
Principal Investigator

Meridian

Saint Luke's Mountain States Tumor Institute - Meridian

Keith S. Lanier
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Keith S. Lanier
Principal Investigator

Nampa

Saint Luke's Mountain States Tumor Institute - Nampa

Keith S. Lanier
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Keith S. Lanier
Principal Investigator

Twin Falls

Saint Luke's Mountain States Tumor Institute-Twin Falls

Keith S. Lanier
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Keith S. Lanier
Principal Investigator

Illinois
Galesburg

Illinois CancerCare-Galesburg Cottage Plaza Office

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Rockford

SwedishAmerican Regional Cancer Center/ACT

Harvey E. Einhorn
Ph: 779-696-9400
Email: cancercare@swedishamerican.org

Harvey E. Einhorn
Principal Investigator

Indiana
South Bend

Northern Indiana Cancer Research Consortium

Jose A. Bufill
Ph: 574-237-1328

Jose A. Bufill
Principal Investigator

Iowa
Ames

McFarland Clinic PC-William R Bliss Cancer Center

Joseph James Merchant
Ph: 515-239-2621
Email: jjmerchant@mcfarlandclinic.com

Joseph James Merchant
Principal Investigator

Mason City

Mercy Medical Center - North Iowa

Joginder (Joe) Singh
Ph: 800-433-3883

Joginder (Joe) Singh
Principal Investigator

Kansas
Lawrence

Lawrence Memorial Hospital

Shaker R. Dakhil
Ph: 316-268-5374
Email: shaker.dakhil@cancercenterofkansas.com

Shaker R. Dakhil
Principal Investigator

Wichita

Wesley Medical Center

Shaker R. Dakhil
Ph: 316-268-5374
Email: shaker.dakhil@cancercenterofkansas.com

Shaker R. Dakhil
Principal Investigator

Louisiana
Baton Rouge

Ochsner Health Center-Summa

Robert Van Buren Emmons
Ph: 888-562-4763

Robert Van Buren Emmons
Principal Investigator

Kenner

Ochsner Medical Center Kenner

Robert Van Buren Emmons
Ph: 888-562-4763

Robert Van Buren Emmons
Principal Investigator

Monroe

University Health-Conway

Richard P. Mansour
Ph: 318-813-1412
Email: rmanso@lsuhsc.edu

Richard P. Mansour
Principal Investigator

New Orleans

Ochsner Medical Center Jefferson

Robert Van Buren Emmons
Ph: 888-562-4763

Robert Van Buren Emmons
Principal Investigator

Shreveport

Louisiana State University Health Sciences Center Shreveport

Richard P. Mansour
Ph: 318-813-1412
Email: rmanso@lsuhsc.edu

Richard P. Mansour
Principal Investigator

Maine
Augusta

Harold Alfond Center for Cancer Care

Thomas H. Openshaw
Ph: 800-987-3005
Email: topenshaw@emh.org

Thomas H. Openshaw
Principal Investigator

Bangor

Eastern Maine Medical Center

Thomas H. Openshaw
Ph: 800-987-3005
Email: topenshaw@emh.org

Thomas H. Openshaw
Principal Investigator

Brewer

Lafayette Family Cancer Center-EMMC

Thomas H. Openshaw
Ph: 800-987-3005
Email: topenshaw@emh.org

Thomas H. Openshaw
Principal Investigator

Massachusetts
Boston

Tufts Medical Center

Andrew M. Evens
Ph: 617-636-5000
Email: ContactUsCancerCenter@TuftsMedicalCenter.org

Andrew M. Evens
Principal Investigator

Michigan
Ann Arbor

Saint Joseph Mercy Hospital

Christopher M. Reynolds
Ph: 734-712-4673
Email: christopher_reynolds@ihacares.com

Christopher M. Reynolds
Principal Investigator

University of Michigan Comprehensive Cancer Center

Tycel J. Phillips
Ph: 800-865-1125
Email: tycelp@med.umich.edu

Tycel J. Phillips
Principal Investigator

Dearborn

Beaumont Hospital-Dearborn

Christopher M. Reynolds
Ph: 734-712-4673
Email: christopher_reynolds@ihacares.com

Christopher M. Reynolds
Principal Investigator

Detroit

Saint John Hospital and Medical Center

Christopher M. Reynolds
Ph: 734-712-4673
Email: christopher_reynolds@ihacares.com

Christopher M. Reynolds
Principal Investigator

Flint

Genesys Hurley Cancer Institute

Christopher M. Reynolds
Ph: 734-712-4673
Email: christopher_reynolds@ihacares.com

Christopher M. Reynolds
Principal Investigator

Jackson

Allegiance Health

Christopher M. Reynolds
Ph: 734-712-4673
Email: christopher_reynolds@ihacares.com

Christopher M. Reynolds
Principal Investigator

Livonia

Saint Mary Mercy Hospital

Christopher M. Reynolds
Ph: 734-712-4673
Email: christopher_reynolds@ihacares.com

Christopher M. Reynolds
Principal Investigator

Pontiac

Saint Joseph Mercy Oakland

Christopher M. Reynolds
Ph: 734-712-4673
Email: christopher_reynolds@ihacares.com

Christopher M. Reynolds
Principal Investigator

Saginaw

Saint Mary's of Michigan

Christopher M. Reynolds
Ph: 734-712-4673
Email: christopher_reynolds@ihacares.com

Christopher M. Reynolds
Principal Investigator

Warren

Saint John Macomb-Oakland Hospital

Christopher M. Reynolds
Ph: 734-712-4673
Email: christopher_reynolds@ihacares.com

Christopher M. Reynolds
Principal Investigator

Minnesota
Bemidji

Sanford Clinic North-Bemidgi

Preston D. Steen
Ph: 701-234-6161
Email: preston.steen@sanfordhealth.org

Preston D. Steen
Principal Investigator

Burnsville

Fairview Ridges Hospital

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Coon Rapids

Mercy Hospital

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Duluth

Essentia Health Cancer Center

Bret E.B. Friday
Ph: 888-203-7267
Email: bret.friday@essentiahealth.org

Bret E.B. Friday
Principal Investigator

Edina

Fairview-Southdale Hospital

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Fergus Falls

Lake Region Healthcare Corporation-Cancer Care

Bret E.B. Friday
Ph: 888-203-7267
Email: bret.friday@essentiahealth.org

Bret E.B. Friday
Principal Investigator

Fridley

Unity Hospital

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Maplewood

Minnesota Oncology Hematology PA-Maplewood

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Saint John's Hospital - Healtheast

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Minneapolis

Abbott-Northwestern Hospital

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Health Partners Inc

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Hennepin County Medical Center

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Robbinsdale

North Memorial Medical Health Center

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Rochester

Mayo Clinic

Grzegorz S. Nowakowski
Ph: 855-776-0015
Email: nowakowski.grzegorz@mayo.edu

Grzegorz S. Nowakowski
Principal Investigator

Saint Louis Park

Park Nicollet Clinic - Saint Louis Park

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Saint Paul

Regions Hospital

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

United Hospital

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Shakopee

Saint Francis Regional Medical Center

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Stillwater

Lakeview Hospital

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Waconia

Ridgeview Medical Center

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Willmar

Rice Memorial Hospital

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Woodbury

Minnesota Oncology and Hematology PA-Woodbury

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Montana
Great Falls

Benefis Healthcare- Sletten Cancer Institute

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Nevada
Las Vegas

Nevada Cancer Research Foundation CCOP

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

New Hampshire
Lebanon

Dartmouth Hitchcock Medical Center

Frederick Lansigan
Ph: 800-639-6918
Email: cancer.research.nurse@dartmouth.edu

Frederick Lansigan
Principal Investigator

New Jersey
Livingston

Saint Barnabas Medical Center

Miguel A. Conde
Ph: 973-322-2470
Email: mconde@barnabashealth.org

Miguel A. Conde
Principal Investigator

Mount Holly

Virtua Memorial

James W. Lee
Ph: 609-914-6762

James W. Lee
Principal Investigator

Vineland

Inspira Medical Center Vineland

Ramakrishna R. Sudhindra
Ph: 856-641-7933
Email: rsudhindra@southernoncology.net

Ramakrishna R. Sudhindra
Principal Investigator

Woodbury

Inspira Medical Center Woodbury

Tami Lee Bach
Ph: 856-641-7933
Email: tami.bach@comcast.net

Tami Lee Bach
Principal Investigator

New York
Rochester

University of Rochester

Jonathan Willmann Friedberg
Ph: 585-275-5830
Email: jonathan_friedberg@urmc.rochester.edu

Jonathan Willmann Friedberg
Principal Investigator

North Carolina
Chapel Hill

UNC Lineberger Comprehensive Cancer Center

Steven I. Park
Ph: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu

Steven I. Park
Principal Investigator

Hendersonville

Hendersonville Hematology and Oncology at Pardee

James Earl Radford
Ph: 828-696-4716
Email: james.radford@pardeehospital.org

James Earl Radford
Principal Investigator

Margaret R Pardee Memorial Hospital

James Earl Radford
Ph: 828-696-4716
Email: james.radford@pardeehospital.org

James Earl Radford
Principal Investigator

Washington

Marion L Shepard Cancer Center at Vidant Beaufort Hospital

John Joseph Inzerillo
Ph: 252-975-4308
Email: john.inzerillo@vidanthealth.com

John Joseph Inzerillo
Principal Investigator

Winston-Salem

Wake Forest University Health Sciences

Zanetta Stewart Lamar
Ph: 336-713-6771
Email: zlamar@wakehealth.edu

Zanetta Stewart Lamar
Principal Investigator

North Dakota
Bismarck

Sanford Bismarck Medical Center

Preston D. Steen
Ph: 701-234-6161
Email: preston.steen@sanfordhealth.org

Preston D. Steen
Principal Investigator

Fargo

Roger Maris Cancer Center

Preston D. Steen
Ph: 701-234-6161
Email: preston.steen@sanfordhealth.org

Preston D. Steen
Principal Investigator

Sanford Clinic North-Fargo

Preston D. Steen
Ph: 701-234-6161
Email: preston.steen@sanfordhealth.org

Preston D. Steen
Principal Investigator

Sanford Medical Center-Fargo

Preston D. Steen
Ph: 701-234-6161
Email: preston.steen@sanfordhealth.org

Preston D. Steen
Principal Investigator

Ohio
Akron

Akron General Medical Center

Esther Hoogland Rehmus
Ph: 330-344-6348

Esther Hoogland Rehmus
Principal Investigator

Canton

Mercy Medical Center

Mitchell Haut
Ph: 888-293-4673

Mitchell Haut
Principal Investigator

Cleveland

MetroHealth Medical Center

Bruce J. Averbook
Ph: 216-778-8526
Email: kbauchens@metrohealth.org

Bruce J. Averbook
Principal Investigator

Columbus

Columbus Oncology and Hematology Associates Inc

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Mount Carmel Health Center West

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Ohio State University Comprehensive Cancer Center

Kami Jo Maddocks
Ph: 800-293-5066
Email: Jamesline@osumc.edu

Kami Jo Maddocks
Principal Investigator

Riverside Methodist Hospital

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

The Mark H Zangmeister Center

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Marietta

Marietta Memorial Hospital

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Maumee

Toledo Clinic Cancer Centers-Maumee

Rex B. Mowat
Ph: 800-444-3561

Rex B. Mowat
Principal Investigator

Newark

Licking Memorial Hospital

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Toledo

Toledo Clinic Cancer Centers-Toledo

Rex B. Mowat
Ph: 800-444-3561

Rex B. Mowat
Principal Investigator

Westerville

Saint Ann's Hospital

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Oregon
Coos Bay

Bay Area Hospital

Keith S. Lanier
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Keith S. Lanier
Principal Investigator

Newberg

Providence Newberg Medical Center

Keith S. Lanier
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Keith S. Lanier
Principal Investigator

Oregon City

Providence Willamette Falls Medical Center

Keith S. Lanier
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Keith S. Lanier
Principal Investigator

Portland

Providence Portland Medical Center

Keith S. Lanier
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Keith S. Lanier
Principal Investigator

Providence Saint Vincent Medical Center

Keith S. Lanier
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Keith S. Lanier
Principal Investigator

Pennsylvania
Allentown

Lehigh Valley Hospital-Cedar Crest

Eliot L. Friedman
Ph: 610-402-2273
Email: eliot_l.friedman@lvh.com

Eliot L. Friedman
Principal Investigator

Danville

Geisinger Medical Center

Joseph Joe Lukose Vadakara
Ph: 570-271-5251
Email: jvadakara@geisinger.edu

Joseph Joe Lukose Vadakara
Principal Investigator

Ephrata

Ephrata Cancer Center

Amir Tabatabai
Ph: 877-441-7957
Email: atabatabai@wellspan.org

Amir Tabatabai
Principal Investigator

Gettysburg

Adams Cancer Center

Amir Tabatabai
Ph: 877-441-7957
Email: atabatabai@wellspan.org

Amir Tabatabai
Principal Investigator

Hanover

Cherry Tree Cancer Center

Amir Tabatabai
Ph: 877-441-7957
Email: atabatabai@wellspan.org

Amir Tabatabai
Principal Investigator

Hazleton

Geisinger Medical Center-Cancer Center Hazleton

Joseph Joe Lukose Vadakara
Ph: 570-271-5251
Email: jvadakara@geisinger.edu

Joseph Joe Lukose Vadakara
Principal Investigator

Hershey

Penn State Milton S Hershey Medical Center

Witold B. Rybka
Ph: 717-531-3779
Email: CTO@hmc.psu.edu

Witold B. Rybka
Principal Investigator

Pottstown

Pottstown Memorial Medical Center

Wei (Frank) Song
Ph: 610-327-7544
Email: frank_song@chs.net

Wei (Frank) Song
Principal Investigator

State College

Mount Nittany Medical Center

Witold B. Rybka
Ph: 717-531-3779
Email: CTO@hmc.psu.edu

Witold B. Rybka
Principal Investigator

West Reading

Reading Hospital

Terrence Paul Cescon
Ph: 610-988-9323
Email: terrence.cescon@readinghealth.org

Terrence Paul Cescon
Principal Investigator

Wilkes-Barre

Geisinger Wyoming Valley/Henry Cancer Center

Joseph Joe Lukose Vadakara
Ph: 570-271-5251
Email: jvadakara@geisinger.edu

Joseph Joe Lukose Vadakara
Principal Investigator

York

WellSpan Health-York Hospital

Amir Tabatabai
Ph: 877-441-7957
Email: atabatabai@wellspan.org

Amir Tabatabai
Principal Investigator

South Dakota
Rapid City

Rapid City Regional Hospital

Joshua Cole Lukenbill
Ph: 605-716-3982
Email: research@rcrh.org

Joshua Cole Lukenbill
Principal Investigator

Sioux Falls

Avera Cancer Institute

Amy K. Krie
Ph: 888-634-7268
Email: oncregulatory@avera.org

Amy K. Krie
Principal Investigator

Sanford Cancer Center-Oncology Clinic

Preston D. Steen
Ph: 701-234-6161
Email: preston.steen@sanfordhealth.org

Preston D. Steen
Principal Investigator

Sanford USD Medical Center - Sioux Falls

Preston D. Steen
Ph: 701-234-6161
Email: preston.steen@sanfordhealth.org

Preston D. Steen
Principal Investigator

Texas
San Antonio

University of Texas Health Science Center at San Antonio

Anand Bhasker Karnad
Ph: 210-450-3800
Email: karnad@uthscsa.edu

Anand Bhasker Karnad
Principal Investigator

Utah
Salt Lake City

Huntsman Cancer Institute/University of Utah

Deborah Marie Stephens
Ph: 801-581-4477
Email: clinical.trials@hci.utah.edu

Deborah Marie Stephens
Principal Investigator

Virginia
Charlottesville

University of Virginia Cancer Center

Michael E. Williams
Ph: 434-243-6322
Email: JME3D@hscmail.mcc.virginia.edu

Michael E. Williams
Principal Investigator

Fishersville

Augusta Health Cancer Center

Zuhair Ghanem
Ph: 540-245-7106

Zuhair Ghanem
Principal Investigator

Martinsville

Memorial Hospital Of Martinsville

Sreedhar Katragadda
Ph: 276-666-7827
Email: sreedhar.katragadda@lpnt.net

Sreedhar Katragadda
Principal Investigator

Washington
Edmonds

Swedish Medical Center-Edmonds

Keith S. Lanier
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Keith S. Lanier
Principal Investigator

Longview

PeaceHealth Saint John Medical Center

Keith S. Lanier
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Keith S. Lanier
Principal Investigator

Seattle

Swedish Medical Center-Ballard Campus

Keith S. Lanier
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Keith S. Lanier
Principal Investigator

Swedish Medical Center-First Hill

Keith S. Lanier
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Keith S. Lanier
Principal Investigator

Vancouver

PeaceHealth Southwest Medical Center

Keith S. Lanier
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Keith S. Lanier
Principal Investigator

Wisconsin
Appleton

Fox Valley Hematology and Oncology SC-Appleton

William A. Conkright
Ph: 920-749-1171
Email: wconkright@fvho.org

William A. Conkright
Principal Investigator

Burlington

Aurora Cancer Care-Burlington

Rubina Qamar
Ph: 888-709-2080
Email: rubina.qamar@aurora.org

Rubina Qamar
Principal Investigator

Eau Claire

Marshfield Clinic Cancer Center at Sacred Heart

Ali W. Bseiso
Ph: 715-389-4457
Email: bseiso.ali@marshfieldclinic.org

Ali W. Bseiso
Principal Investigator

Sacred Heart Hospital

Ali W. Bseiso
Ph: 715-389-4457
Email: bseiso.ali@marshfieldclinic.org

Ali W. Bseiso
Principal Investigator

Elkhorn

Aurora Cancer Care-Southern Lakes

Rubina Qamar
Ph: 888-709-2080
Email: rubina.qamar@aurora.org

Rubina Qamar
Principal Investigator

Grafton

Aurora Cancer Care-Grafton

Rubina Qamar
Ph: 888-709-2080
Email: rubina.qamar@aurora.org

Rubina Qamar
Principal Investigator

Green Bay

Aurora BayCare Medical Center

Rubina Qamar
Ph: 888-709-2080
Email: rubina.qamar@aurora.org

Rubina Qamar
Principal Investigator

La Crosse

Gundersen Lutheran Medical Center

Kurt Oettel
Ph: 608-775-2385
Email: cancerctr@gundersenhealth.org

Kurt Oettel
Principal Investigator

Madison

University of Wisconsin Hospital and Clinics

Vaishalee Padgaonkar Kenkre
Ph: 877-405-6866
Email: vpkenkre@medicine.wisc.edu

Vaishalee Padgaonkar Kenkre
Principal Investigator

Marinette

Bay Area Medical Center

Rubina Qamar
Ph: 888-709-2080
Email: rubina.qamar@aurora.org

Rubina Qamar
Principal Investigator

Vince Lombardi Cancer Clinic-Marinette

Rubina Qamar
Ph: 888-709-2080
Email: rubina.qamar@aurora.org

Rubina Qamar
Principal Investigator

Marshfield

Marshfield Clinic

Ali W. Bseiso
Ph: 715-389-4457
Email: bseiso.ali@marshfieldclinic.org

Ali W. Bseiso
Principal Investigator

Saint Joseph's Hospital

Ali W. Bseiso
Ph: 715-389-4457
Email: bseiso.ali@marshfieldclinic.org

Ali W. Bseiso
Principal Investigator

Menomonee Falls

Aurora Advanced Healthcare Inc-Menomonee Falls

Rubina Qamar
Ph: 888-709-2080
Email: rubina.qamar@aurora.org

Rubina Qamar
Principal Investigator

Milwaukee

Aurora Cancer Care-Milwaukee

Rubina Qamar
Ph: 888-709-2080
Email: rubina.qamar@aurora.org

Rubina Qamar
Principal Investigator

Aurora Cancer Care-Milwaukee South

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Aurora Saint Luke's Medical Center

Rubina Qamar
Ph: 888-709-2080
Email: rubina.qamar@aurora.org

Rubina Qamar
Principal Investigator

Aurora Sinai Medical Center

Rubina Qamar
Ph: 888-709-2080
Email: rubina.qamar@aurora.org

Rubina Qamar
Principal Investigator

Froedtert and the Medical College of Wisconsin

Timothy Sean Fenske
Ph: 414-805-4380
Email: tfenske@mcw.edu

Timothy Sean Fenske
Principal Investigator

Minocqua

Marshfield Clinic-Minocqua Center

Ali W. Bseiso
Ph: 715-389-4457
Email: bseiso.ali@marshfieldclinic.org

Ali W. Bseiso
Principal Investigator

New Richmond

Cancer Center of Western Wisconsin

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Oconomowoc

Oconomowoc Memorial Hospital-ProHealth Care Inc

Timothy Robert Wassenaar
Ph: 262-928-5539
Email: Chanda.miller@phci.org

Timothy Robert Wassenaar
Principal Investigator

Oshkosh

Vince Lombardi Cancer Clinic - Oshkosh

Rubina Qamar
Ph: 888-709-2080
Email: rubina.qamar@aurora.org

Rubina Qamar
Principal Investigator

Rice Lake

Lakeview Medical Center-Marshfield Clinic

Ali W. Bseiso
Ph: 715-389-4457
Email: bseiso.ali@marshfieldclinic.org

Ali W. Bseiso
Principal Investigator

Marshfield Clinic-Rice Lake Center

Ali W. Bseiso
Ph: 715-389-4457
Email: bseiso.ali@marshfieldclinic.org

Ali W. Bseiso
Principal Investigator

Sheboygan

Vince Lombardi Cancer Clinic-Sheboygan

Rubina Qamar
Ph: 888-709-2080
Email: rubina.qamar@aurora.org

Rubina Qamar
Principal Investigator

Stevens Point

Marshfield Clinic Cancer Care at Saint Michael's Hospital

Ali W. Bseiso
Ph: 715-389-4457
Email: bseiso.ali@marshfieldclinic.org

Ali W. Bseiso
Principal Investigator

Saint Michael's Hospital

Ali W. Bseiso
Ph: 715-389-4457
Email: bseiso.ali@marshfieldclinic.org

Ali W. Bseiso
Principal Investigator

Summit

Aurora Medical Center in Summit

Rubina Qamar
Ph: 888-709-2080
Email: rubina.qamar@aurora.org

Rubina Qamar
Principal Investigator

Two Rivers

Vince Lombardi Cancer Clinic

Rubina Qamar
Ph: 888-709-2080
Email: rubina.qamar@aurora.org

Rubina Qamar
Principal Investigator

Waukesha

UW Cancer Center at ProHealth Care

Timothy Robert Wassenaar
Ph: 262-928-5539
Email: Chanda.miller@phci.org

Timothy Robert Wassenaar
Principal Investigator

Waukesha Memorial Hospital

Timothy Robert Wassenaar
Ph: 262-928-5539
Email: Chanda.miller@phci.org

Timothy Robert Wassenaar
Principal Investigator

Wausau

Marshfield Clinic-Wausau Center

Ali W. Bseiso
Ph: 715-389-4457
Email: bseiso.ali@marshfieldclinic.org

Ali W. Bseiso
Principal Investigator

Wauwatosa

Aurora Cancer Care-Milwaukee West

Rubina Qamar
Ph: 888-709-2080
Email: rubina.qamar@aurora.org

Rubina Qamar
Principal Investigator

West Allis

Aurora West Allis Medical Center

Rubina Qamar
Ph: 888-709-2080
Email: rubina.qamar@aurora.org

Rubina Qamar
Principal Investigator

Weston

Diagnostic and Treatment Center

Ali W. Bseiso
Ph: 715-389-4457
Email: bseiso.ali@marshfieldclinic.org

Ali W. Bseiso
Principal Investigator

Marshfield Clinic - Weston Center

Ali W. Bseiso
Ph: 715-389-4457
Email: bseiso.ali@marshfieldclinic.org

Ali W. Bseiso
Principal Investigator

Wisconsin Rapids

Marshfield Clinic - Wisconsin Rapids Center

Ali W. Bseiso
Ph: 715-389-4457
Email: bseiso.ali@marshfieldclinic.org

Ali W. Bseiso
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01856192

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.