Ibrutinib and Rituximab Compared with Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients with Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentActive18 to 70E1912
NCI-2014-00118, ECOG-E1912, NCT02048813

Trial Description

Summary

This randomized phase III trial studies ibrutinib and rituximab to see how well they work compared to fludarabine phosphate, cyclophosphamide, and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, 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, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether fludarabine phosphate, cyclophosphamide, and rituximab may work better than ibrutinib and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.

Further Study Information

PRIMARY OBJECTIVES:

I. To evaluate the ability of Ibrutinib-based induction therapy to prolong progression free survival (PFS) compared to standard fludarabine phosphate, cyclophosphamide, and rituximab (FCR) chemoimmunotherapy for younger patients with chronic lymphocytic leukemia (CLL).

SECONDARY OBJECTIVES:

I. Evaluate overall survival (OS) of patients based on treatment arm.

II. Monitor and assess toxicity of treatment with Ibrutinib-based induction relative to standard FCR chemotherapy.

III. To compare quality of life (QOL) in CLL patients during the first 6 months of treatment among patients receiving Ibrutinib-based induction therapy relative to standard FCR chemoimmunotherapy.

IV. To compare QOL over the long-term in CLL patients receiving continuous therapy using Ibrutinib to that of CLL patients who completed FCR therapy.

V. Determine the effect of pretreatment clinical and biological characteristics (e.g. disease stage, immunoglobulin heavy chain variable region gene [IGHV] mutation status, fluorescent in situ hybridization [FISH]) on clinical outcomes (e.g. complete response, PFS) of the different arms.

VI. Determine if the minimal residual disease (MRD) status as assessed by flow cytometry at different time points during and after treatment is an effective surrogate marker for prolonged PFS and overall survival.

VII. Compare the genetic abnormalities and dynamics of intra-clonal architecture of CLL patients before and after treatment with chemoimmunotherapy (CIT) and non-CIT approaches and explore relationships with treatment resistance.

VIII. Explore the effects of FCR and Ibrutinib-based therapy on T-cell immune function.

IX. Conduct confirmatory validation genotyping of single nucleotide polymorphisms (SNPs) associated with the efficacy and toxicity of fludarabine-based therapy as in a prior Eastern Cooperative Oncology Group (ECOG) genome-wide association study (GWAS) analysis in the E2997 trial.

X. Evaluate the ability of prognostic model that incorporates clinical and biologic characters to predict a response to therapy and clinical outcome (PFS, OS).

XI. Evaluate signaling networks downstream of the B-cell receptor in patients receiving Ibrutinib-based therapy.

XII. Collect relapse samples to study mechanisms of resistance to both FCR and Ibrutinib-based therapy.

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

ARM A: Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Beginning course 2, patients also receive rituximab intravenously (IV) over 4 hours on day 1 (days 1 and 2 of course 2 only). Treatment repeats every 28 days for 7 courses. In the absence of disease progression, patients may continue ibrutinib PO QD.

ARM B: Patients receive rituximab as seen in Arm A and fludarabine phosphate IV over 30 minutes and cyclophosphamide IV over 30 minutes on days 1-3. Treatment repeats every 28 days for 6 courses.

After completion of study treatment, patients are followed up for 10 years.

Eligibility Criteria

Inclusion Criteria:

Diagnosis of CLL according to the National Cancer Institute (NCI)/Internal Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria or small lymphocytic lymphoma (SLL) according to the World Health Organization (WHO) criteria; this includes previous documentation of:

Biopsy-proven small lymphocytic lymphoma or

Diagnosis of CLL according to the NCI/IWCLL criteria as evidenced by all of the following:

  • Peripheral blood lymphocyte count of greater than 5 x 10^9/L
  • Immunophenotype consistent with CLL defined as:

*** The predominant population of lymphocytes share both B-cell antigens (cluster of differentiation [CD]19, CD20 [typically dim expression], or CD23) as well as CD5 in the absence of other pan-T-cell markers (CD3, CD2, etc)

*** Clonality as evidenced by kappa or lambda light chain restriction (typically dim immunoglobulin expression)

Negative FISH analysis for t(11;14)(immunoglobulin heavy locus [IgH]/cyclin D1 [CCND1]) on peripheral blood or tissue biopsy (e.g. marrow aspirate) or negative immunohistochemical stains for cyclin D1 staining on involved tissue biopsy (e.g. marrow aspirate or lymph node biopsy)

No prior chemotherapy, Bruton's tyrosine kinase (BTK) inhibitor therapy, or monoclonal anti-body therapy for treatment of CLL or SLL

Has met at least one of the following indications for treatment:

Evidence of progressive marrow failure as manifested by the development of worsening anemia (hemoglobin [Hg] < 11 g/dl) and/or thrombocytopenia (platelets < 100 x 10^9/L)

Symptomatic or progressive lymphadenopathy, splenomegaly, or hepatomegaly

One or more of the following disease-related symptoms:

  • Weight loss >= 10% within the previous 6 months
  • Grade 2 or 3 fatigue attributed to CLL
  • Fevers > 100.5 Fahrenheit (F) for 2 weeks without evidence of infection
  • Clinically significant night sweats without evidence of infection

Progressive lymphocytosis (not due to the effects of corticosteroids) with an increase of > 50% over a two-month period or an anticipated doubling time of less than six months

ECOG performance status between 0-2

Life expectancy of >= 12 months

Ability to tolerate FCR based therapy

No deletion of 17p13 on cytogenetic analysis by FISH

Glomerular filtration rate (GFR) > 40 mL/minute as calculated by the Cockcroft-Gault formula

Total bilirubin =< 2.5 x upper limit of normal (ULN) unless due to Gilbert's disease; for those with a total bilirubin > 2.5 x ULN, a direct bilirubin should be performed and must be < 1.5 mg/dL for Gilbert's to be diagnosed; if value is higher due to hepatic involvement by CLL, patient is eligible

Serum glutamic oxaloacetic transaminase (SGOT) aspartate transaminase (AST)/serum glutamate-pyruvate transaminase (SGPT) alanine transaminase (ALT) =< 3.0 x the institutional ULN; if value is higher due to hepatic involvement by CLL, patient is eligible

Prothrombin time (PT)/international normalized ratio (INR) < 1.5 ULN and partial thromboplastin time (PTT) activated partial thromboplastin time (aPTT) < 1.5 X ULN; if value is higher due to hepatic involvement by CLL, patient is eligible

No active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment; patients who have a positive Coombs test but no evidence of hemolysis are NOT excluded from participation

No current use of corticosteroids; EXCEPTION: low doses of steroids (< 10 mg of prednisone or equivalent dose of other steroid) used for treatment of non-hematologic medical condition (e.g. chronic adrenal insufficiency) is permitted

No previous use of corticosteroids for autoimmune complications that have developed since the initial diagnosis of CLL; prior use of corticosteroids for reasons other than treatment of autoimmune complications is allowed

No other active primary malignancy (other than non-melanomatous skin cancer or carcinoma in situ of the cervix) requiring treatment or limiting expected survival to =< 2 years; NOTE: if there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy for their cancer)

Able to adhere to the study visit schedule and other protocol requirements

No major surgery within the last 4 weeks (28 days) of first dose of study drug or minor surgery within 3 days of first dose of study drug

No radiation therapy =< 4 weeks prior to registration

Patients with human immunodeficiency virus (HIV) infection may be eligible provided they meet the following criteria:

CD4-positive cell count >= lower limit of institutional normal

HIV viral load < 10,000 copies HIV ribonucleic acid (RNA)/mL (if not on anti-HIV therapy) OR < 50 copies HIV RNA/mL (if on anti-HIV therapy)

No evidence of hepatitis B or C infection

No evidence of resistant strains of HIV

No history of acquired immune deficiency syndrome (AIDS)-defining condition

Patients must not have any of the following conditions:

Congestive heart failure or New York Heart Association Functional Classification III or IV congestive heart failure

History of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to registration

Recent infections requiring systemic treatment; need to have completed anti-biotic therapy >14 days before the first dose of study drug

Cerebral vascular accident or intracranial bleed within the last 6 months

Infection with known chronic, active hepatitis C

Serologic status reflecting active hepatitis B or C infection; patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment (PCR positive patients will be excluded)

Patients are not eligible if they require treatment with a strong cytochrome P450 (CYP) family 3, subfamily A (3A) inhibitor

Patients may not be on any other investigational agents

Patients may not have received warfarin or another vitamin K antagonist in the preceding 30 days

Women must not be pregnant or breast-feeding; female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to registration to rule out pregnancy; female patients who are of non-reproductive potential are those who are post-menopausal by history (i.e. no menses for >= 1 year); OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy

Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for 90 days after the last dose of study drug

Patient must be able to swallow capsules and not have the following conditions:

Disease significantly affecting gastrointestinal function

Resection of the stomach or small bowel

Symptomatic inflammatory bowel disease

Ulcerative colitis

Partial or complete bowel obstruction

Patient must not be on any other systemic immunosuppressant therapy other than corticosteroids within 28 days of the first dose of study drug

Patient must not be vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug

Patient must not have any known bleeding disorders (e.g., von Willebrand’s disease) or hemophilia

Patient must not have currently active, clinically significant hepatic impairment (>= moderate hepatic impairment according to the NCI/Child Pugh)

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

National Cancer Institute

  • National Cancer Institute
Tait D. Shanafelt, Principal Investigator

Trial Sites

U.S.A.

Alaska
Fairbanks

Fairbanks Memorial Hospital

John A. Keech
Ph: 907-458-5380

John A. Keech
Principal Investigator

Arizona
Scottsdale

Mayo Clinic in Arizona

Tait D. Shanafelt
Ph: 507-266-2157
Email: shanafelt.tait@mayo.edu

Tait D. Shanafelt
Principal Investigator

Colorado
Denver

Colorado Cancer Research Program NCORP

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Denver Health Medical Center

Keren Sturtz
Ph: 303-649-5480
Email: KSturtz@co-cancerresearch.org

Keren Sturtz
Principal Investigator

National Jewish Health-Main Campus

Keren Sturtz
Ph: 303-649-5480
Email: KSturtz@co-cancerresearch.org

Keren Sturtz
Principal Investigator

Golden

National Jewish Health-Western Hematology Oncology

Keren Sturtz
Ph: 303-649-5480
Email: KSturtz@co-cancerresearch.org

Keren Sturtz
Principal Investigator

Georgia
Savannah

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Grant Carlton Lewis
Ph: 912-350-8568

Grant Carlton Lewis
Principal Investigator

Idaho
Coeur D'Alene

Kootenai Medical Center

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

Benjamin T. Marchello
Principal Investigator

Post Falls

Kootenai Cancer Center

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

Benjamin T. Marchello
Principal Investigator

Sandpoint

Kootenai Cancer

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

Benjamin T. Marchello
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: 779-696-9334
Email: cancercare@swedishamerican.org

Harvey E. Einhorn
Principal Investigator

Indiana
Anderson

Saint Vincent Anderson Regional Hospital/Cancer Center

Ubaidullah Sharief
Ph: 765-646-8413
Email: ubaidullah.sharief@stvincent.org

Ubaidullah Sharief
Principal Investigator

Iowa
Sioux City

Siouxland Regional Cancer Center

Donald B. Wender
Ph: 712-252-0088
Email: drednew@msn.com

Donald B. Wender
Principal Investigator

Louisiana
Shreveport

CHRISTUS Highland Medical Center

Robert Van Buren Emmons
Ph: 888-562-4763
Email: remmons@ochsner.org

Robert Van Buren Emmons
Principal Investigator

Maine
Augusta

Harold Alfond Center for Cancer Care

Thomas H. Openshaw
Ph: 207-973-7807
Email: topenshaw@emh.org

Thomas H. Openshaw
Principal Investigator

Bangor

Eastern Maine Medical Center

Thomas H. Openshaw
Ph: 207-973-7807
Email: topenshaw@emh.org

Thomas H. Openshaw
Principal Investigator

Brewer

Lafayette Family Cancer Center-EMMC

Thomas H. Openshaw
Ph: 207-973-7807
Email: topenshaw@emh.org

Thomas H. Openshaw
Principal Investigator

Rockport

Penobscot Bay Medical Center

Thomas H. Openshaw
Ph: 207-973-7807
Email: topenshaw@emh.org

Thomas H. Openshaw
Principal Investigator

Maryland
Baltimore

University of Maryland/Greenebaum Cancer Center

Seung-Tae Lee
Ph: 410-328-6896
Email: seunglee@umm.edu

Seung-Tae Lee
Principal Investigator

Massachusetts
Boston

Eastern Cooperative Oncology Group

Tait D. Shanafelt
Ph: 507-284-2358
Email: shanafelt.tait@mayo.edu

Tait D. Shanafelt
Principal Investigator

Springfield

Baystate Medical Center

Syed S. Ali
Ph: 413-794-3565
Email: tamara.wrenn@baystatehealth.org

Syed S. Ali
Principal Investigator

Michigan
Farmington

Botsford General Hospital

Ishmael A. Jaiyesimi
Ph: 248-551-7695

Ishmael A. Jaiyesimi
Principal Investigator

Grosse Pointe

William Beaumont Hospital-Grosse Point

Ishmael A. Jaiyesimi
Ph: 248-551-7695

Ishmael A. Jaiyesimi
Principal Investigator

Novi

Assarian Cancer Center

Robert Eric Bloom
Ph: 248-849-5337
Email: jaswinder.grewal@stjohn.org

Robert Eric Bloom
Principal Investigator

Roseville

Michigan Cancer Specialists

Ishmael A. Jaiyesimi
Ph: 248-551-7695

Ishmael A. Jaiyesimi
Principal Investigator

Royal Oak

Cancer Care Associates PC

Ishmael A. Jaiyesimi
Ph: 248-551-7695

Ishmael A. Jaiyesimi
Principal Investigator

Comprehensive Medical Center PLLC

Ishmael A. Jaiyesimi
Ph: 248-551-7695

Ishmael A. Jaiyesimi
Principal Investigator

Hematology Oncology Consultants PC

Ishmael A. Jaiyesimi
Ph: 248-551-7695

Ishmael A. Jaiyesimi
Principal Investigator

Oakland Colon and Rectal Association

Ishmael A. Jaiyesimi
Ph: 248-551-7695

Ishmael A. Jaiyesimi
Principal Investigator

Oakland Medical Group

Ishmael A. Jaiyesimi
Ph: 248-551-7695

Ishmael A. Jaiyesimi
Principal Investigator

William Beaumont Hospital-Royal Oak

Ishmael A. Jaiyesimi
Ph: 248-551-7695

Ishmael A. Jaiyesimi
Principal Investigator

Southfield

Providence Hospital-Southfield Cancer Center

Robert Eric Bloom
Ph: 248-849-5337
Email: jaswinder.grewal@stjohn.org

Robert Eric Bloom
Principal Investigator

Sterling Heights

Mitchell Folbe MD PC

Ishmael A. Jaiyesimi
Ph: 248-551-7695

Ishmael A. Jaiyesimi
Principal Investigator

Premier Hematology Oncology Care

Ishmael A. Jaiyesimi
Ph: 248-551-7695

Ishmael A. Jaiyesimi
Principal Investigator

Troy

Claudia BR Herke MD PC

Ishmael A. Jaiyesimi
Ph: 248-551-7695

Ishmael A. Jaiyesimi
Principal Investigator

Hematology Oncology Consultants PC-Troy

Ishmael A. Jaiyesimi
Ph: 248-551-7695

Ishmael A. Jaiyesimi
Principal Investigator

Michigan Institute of Urology-Town Center

Ishmael A. Jaiyesimi
Ph: 248-551-7695

Ishmael A. Jaiyesimi
Principal Investigator

William Beaumont Hospital - Troy

Ishmael A. Jaiyesimi
Ph: 248-551-7695

Ishmael A. Jaiyesimi
Principal Investigator

Minnesota
Rochester

Mayo Clinic

Tait D. Shanafelt
Ph: 507-266-2157
Email: shanafelt.tait@mayo.edu

Tait D. Shanafelt
Principal Investigator

Montana
Anaconda

Community Hospital of Anaconda

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

Benjamin T. Marchello
Principal Investigator

Billings

Billings Clinic Cancer Center

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

Benjamin T. Marchello
Principal Investigator

Montana Cancer Consortium NCORP

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Saint Vincent Healthcare

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

Benjamin T. Marchello
Principal Investigator

Bozeman

Bozeman Deaconess Hospital

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

Benjamin T. Marchello
Principal Investigator

Butte

Saint James Community Hospital and Cancer Treatment Center

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

Benjamin T. Marchello
Principal Investigator

Great Falls

Benefis Healthcare- Sletten Cancer Institute

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

Benjamin T. Marchello
Principal Investigator

Great Falls Clinic

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

Benjamin T. Marchello
Principal Investigator

Helena

Saint Peter's Community Hospital

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

Benjamin T. Marchello
Principal Investigator

Kalispell

Kalispell Regional Medical Center

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

Benjamin T. Marchello
Principal Investigator

Missoula

Community Medical Hospital

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

Benjamin T. Marchello
Principal Investigator

Saint Patrick Hospital - Community Hospital

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

Benjamin T. Marchello
Principal Investigator

Nebraska
Lincoln

Nebraska Cancer Research Center

Gamini S. Soori
Ph: 402-991-8070
Email: gsoori@mvcc.cc

Gamini S. Soori
Principal Investigator

Nebraska Hematology and Oncology

Gamini S. Soori
Ph: 402-991-8070
Email: gsoori@mvcc.cc

Gamini S. Soori
Principal Investigator

Southeast Nebraska Cancer Center

Gamini S. Soori
Ph: 402-991-8070
Email: gsoori@mvcc.cc

Gamini S. Soori
Principal Investigator

Norfolk

Faith Regional Medical Offices West

Gamini S. Soori
Ph: 402-991-8070
Email: gsoori@mvcc.cc

Gamini S. Soori
Principal Investigator

North Platte

Great Plains Regional Medical Center

Gamini S. Soori
Ph: 402-991-8070
Email: gsoori@mvcc.cc

Gamini S. Soori
Principal Investigator

Omaha

Missouri Valley Cancer Consortium

Gamini S. Soori
Ph: 402-991-8070ext202
Email: mwilwerding@mvcc.cc

Gamini S. Soori
Principal Investigator

Oncology Hematology West

Gamini S. Soori
Ph: 402-991-8070
Email: gsoori@mvcc.cc

Gamini S. Soori
Principal Investigator

Oncology Hematology West PC

Gamini S. Soori
Ph: 402-991-8070
Email: gsoori@mvcc.cc

Gamini S. Soori
Principal Investigator

Scottsbluff

Regional West Medical Center

Gamini S. Soori
Ph: 402-991-8070
Email: gsoori@mvcc.cc

Gamini S. Soori
Principal Investigator

Nevada
Las Vegas

Nevada Cancer Research Foundation CCOP

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

New York
Glens Falls

Glens Falls Hospital

George Fuad Atweh
Ph: 802-656-5493
Email: george.atweh@uvmhealth.org

George Fuad Atweh
Principal Investigator

Manhasset

North Shore University Hospital

Jacqueline C. Barrientos
Ph: 516-734-8954
Email: jbarrientos@nshs.edu

Jacqueline C. Barrientos
Principal Investigator

New Hyde Park

Long Island Jewish Medical Center

Jacqueline C. Barrientos
Ph: 516-734-8954
Email: jbarrientos@nshs.edu

Jacqueline C. Barrientos
Principal Investigator

North Shore-LIJ Health System/Center for Advanced Medicine

Jacqueline C. Barrientos
Ph: 516-734-8954
Email: jbarrientos@nshs.edu

Jacqueline C. Barrientos
Principal Investigator

Rochester

University of Rochester

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

Jonathan Willmann Friedberg
Principal Investigator

North Carolina
Asheville

Asheville Hematology-Oncology Associates

Raymond Thertulien
Ph: 855-774-5433
Email: raymond.thertulien@21co.com

Raymond Thertulien
Principal Investigator

Cancer Care of Western North Carolina

Christopher H. Chay
Ph: 828-418-0932
Email: chay@ccwnc.com

Christopher H. Chay
Principal Investigator

Mission Hospital-Memorial Campus

Christopher H. Chay
Ph: 828-418-0932
Email: chay@ccwnc.com

Christopher H. Chay
Principal Investigator

Hendersonville

Park Ridge Hospital Breast Health Center

Raymond Thertulien
Ph: 855-774-5433
Email: raymond.thertulien@21co.com

Raymond Thertulien
Principal Investigator

Kinston

Kinston Medical Specialists PA

Peter Robins Watson
Ph: 252-559-2200

Peter Robins Watson
Principal Investigator

Winston-Salem

Wake Forest University Health Sciences

Leslie Renee Ellis
Ph: 336-713-6771
Email: lrellis@wfubmc.edu

Leslie Renee Ellis
Principal Investigator

Ohio
Akron

Akron General Medical Center

Esther Hoogland Rehmus
Ph: 330-344-6348
Email: esther.rehmus@akrongeneral.org

Esther Hoogland Rehmus
Principal Investigator

Belpre

Strecker Cancer Center-Belpre

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

John Philip Kuebler
Principal Investigator

Chillicothe

Adena Regional Medical Center

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

John Philip Kuebler
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

Doctors Hospital

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

John Philip Kuebler
Principal Investigator

Grant Medical Center

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

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

Delaware

Delaware Health Center-Grady Cancer Center

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

John Philip Kuebler
Principal Investigator

Delaware Radiation Oncology

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

John Philip Kuebler
Principal Investigator

Grady Memorial Hospital

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

John Philip Kuebler
Principal Investigator

Lancaster

Fairfield Medical 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

Mount Vernon

Knox Community Hospital

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

John Philip Kuebler
Principal Investigator

Newark

Licking Memorial Hospital

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

John Philip Kuebler
Principal Investigator

Newark Radiation Oncology

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

John Philip Kuebler
Principal Investigator

Portsmouth

Southern Ohio Medical Center

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

John Philip Kuebler
Principal Investigator

Westerville

Saint Ann's Hospital

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

John Philip Kuebler
Principal Investigator

Zanesville

Genesis Healthcare System Cancer Care Center

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

John Philip Kuebler
Principal Investigator

Pennsylvania
West Reading

Reading Hospital

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

Terrence Paul Cescon
Principal Investigator

Williamsport

Susquehanna Cancer Center

Warren Lewis Robinson
Ph: 800-598-4282

Warren Lewis Robinson
Principal Investigator

South Carolina
Gaffney

Gibbs Cancer Center-Gaffney

Asim Ranjan Pati
Ph: 800-486-5941
Email: apati@gibbscc.org

Asim Ranjan Pati
Principal Investigator

Greer

Gibbs Cancer Center-Pelham

Asim Ranjan Pati
Ph: 800-486-5941
Email: apati@gibbscc.org

Asim Ranjan Pati
Principal Investigator

Spartanburg

Spartanburg Medical Center

Asim Ranjan Pati
Ph: 800-486-5941
Email: apati@gibbscc.org

Asim Ranjan Pati
Principal Investigator

Union

MGC Hematology Oncology-Union

Asim Ranjan Pati
Ph: 800-486-5941
Email: apati@gibbscc.org

Asim Ranjan Pati
Principal Investigator

Vermont
Berlin

Central Vermont Medical Center/National Life Cancer Treatment

George Fuad Atweh
Ph: 802-656-5493
Email: george.atweh@uvmhealth.org

George Fuad Atweh
Principal Investigator

Burlington

University of Vermont College of Medicine

George Fuad Atweh
Ph: 802-656-8990
Email: george.atweh@uvmhealth.org

George Fuad Atweh
Principal Investigator

University of Vermont Medical Center

George Fuad Atweh
Ph: 802-656-5493
Email: george.atweh@uvmhealth.org

George Fuad Atweh
Principal Investigator

Washington
Auburn

MultiCare Auburn Medical Center

John A. Keech
Ph: 907-458-5380

John A. Keech
Principal Investigator

Bainbridge Island

Virginia Mason Bainbridge Island Medical Center

John A. Keech
Ph: 907-458-5380

John A. Keech
Principal Investigator

Bellevue

Overlake Hospital Medical Center

John A. Keech
Ph: 907-458-5380

John A. Keech
Principal Investigator

Federal Way

Virginia Mason Federal Way Medical Center

John A. Keech
Ph: 907-458-5380

John A. Keech
Principal Investigator

Gig Harbor

MultiCare Gig Harbor Medical Park

John A. Keech
Ph: 907-458-5380

John A. Keech
Principal Investigator

Tacoma/Valley Radiation Oncology Centers-Gig Harbor

John A. Keech
Ph: 907-458-5380

John A. Keech
Principal Investigator

Kennewick

Northwest Cancer Clinic

John A. Keech
Ph: 907-458-5380

John A. Keech
Principal Investigator

Lynnwood

Virginia Mason Lynnwood Medical Center

John A. Keech
Ph: 907-458-5380

John A. Keech
Principal Investigator

Port Townsend

Jefferson Healthcare

John A. Keech
Ph: 253-530-8062
Email: john.keech@multicare.org

John A. Keech
Principal Investigator

Poulsbo

Peninsula Cancer Center

John A. Keech
Ph: 907-458-5380

John A. Keech
Principal Investigator

Puyallup

MultiCare Good Samaritan Hospital

John A. Keech
Ph: 907-458-5380

John A. Keech
Principal Investigator

Tacoma/Valley Radiation Oncology Centers-Puyallup

John A. Keech
Ph: 907-458-5380

John A. Keech
Principal Investigator

Seattle

Virginia Mason Medical Center

John A. Keech
Ph: 907-458-5380

John A. Keech
Principal Investigator

Tacoma

Multicare Health System

John A. Keech
Ph: 907-458-5380

John A. Keech
Principal Investigator

MultiCare Tacoma General Hospital

John A. Keech
Ph: 907-458-5380

John A. Keech
Principal Investigator

Tacoma/Valley Radiation Oncology Centers-Jackson Hall

John A. Keech
Ph: 907-458-5380

John A. Keech
Principal Investigator

Tacoma/Valley Radiation Oncology Centers-Saint Joe's

John A. Keech
Ph: 907-458-5380

John A. Keech
Principal Investigator

Wisconsin
Milwaukee

Aurora Cancer Care-Milwaukee South

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Mukwonago

D N Greenwald Center

Timothy Robert Wassenaar
Ph: 262-928-7537
Email: Chanda.miller@phci.org

Timothy Robert Wassenaar
Principal Investigator

Oconomowoc

Oconomowoc Memorial Hospital-ProHealth Care Inc

Timothy Robert Wassenaar
Ph: 262-928-7537
Email: Chanda.miller@phci.org

Timothy Robert Wassenaar
Principal Investigator

Waukesha

UW Cancer Center at ProHealth Care

Timothy Robert Wassenaar
Ph: 262-928-7537
Email: Chanda.miller@phci.org

Timothy Robert Wassenaar
Principal Investigator

Waukesha Memorial Hospital

Timothy Robert Wassenaar
Ph: 262-928-7537
Email: Chanda.miller@phci.org

Timothy Robert Wassenaar
Principal Investigator

Wisconsin Rapids

Aspirus UW Cancer Center

Ronnie James Kirschling
Ph: 715-421-7408
Email: kirron@rhahealthcare.org

Ronnie James Kirschling
Principal Investigator

Wyoming
Cody

Big Horn Basin Cancer Center

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

Benjamin T. Marchello
Principal Investigator

Billings Clinic-Cody

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

Benjamin T. Marchello
Principal Investigator

Sheridan

Welch Cancer Center

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

Benjamin T. Marchello
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT02048813

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.