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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentActive18 to 70NCINCI-2014-00118
ECOG-E1912, E1912, U10CA021115, U10CA180820, 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 or by stopping them from dividing. 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 are more effective 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 x10^9/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 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) =< 2.5 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 28 days prior to registration or minor surgery within the last 5 days
  • 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:
  • New York Heart Association class III or IV heart disease
  • Recent myocardial infarction (=< 3 months)
  • Uncontrolled infection
  • Cerebral vascular accident or intracranial bleed within the last 6 months
  • Infection with known chronic, active hepatitis C
  • Positive serology for hepatitis B defined as a positive test for hepatitis B surface antigen (HBsAg); in addition, if negative for HBsAg but hepatitis B core antibody (HBcAb) positive (regardless of HBsAb status), a hepatitis B deoxyribonucleic acid (DNA) test will be performed and, if positive the subject will be ineligible
  • Patients are not eligible if they require chronic use of strong or moderate cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)/5 inhibitors or inducers at the time of registration
  • 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; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
  • Has not undergone a hysterectomy or bilateral oophorectomy; or
  • 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)
  • 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 the duration of their participation in the study

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Tait ShanafeltPrincipal Investigator

Trial Sites

U.S.A.
Alabama
  Birmingham
 UAB Comprehensive Cancer Center
 Harry Paul Erba Ph: 205-934-0309
Arizona
  Scottsdale
 Mayo Clinic Scottsdale
 Tait D. Shanafelt Ph: 507-538-7623
Arkansas
  Jonesboro
 NEA Medical Clinic - East Matthews
 Carroll Dean Scroggin Ph: 888-823-5923
  Email: ctsucontact@westat.com
California
  Palo Alto
 Palo Alto Medical Foundation
 Peter P. Yu Ph: 408-730-2800
  Paradise
 Feather River Hospital Cancer Center
 Sam Mazj Ph: 530-876-7995
  Email: haleew@ah.org
  San Luis Obispo
 Coastal Integrative Cancer Care
 Brian A DiCarlo
  Email: sdiaz@ohmacc.com
  Santa Cruz
 Palo Alto Medical Foundation-Santa Cruz
 Glenn D Wong Ph: 831-460-7355
  Stanford
 Stanford Cancer Center
 Steven E Coutre Ph: 650-498-7061
  Email: ccto-office@stanford.edu
  Sunnyvale
 Palo Atlo Medical Foundation-Sunnyvale
 Peter P. Yu Ph: 408-730-2800
Colorado
  Aurora
 Medical Center of Aurora - South Campus
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Aurora
 Keren Sturtz Ph: 888-785-6789
  Boulder
 Boulder Community Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers-Boulder
 Keren Sturtz Ph: 888-785-6789
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers at the Pavilion
 Keren Sturtz Ph: 888-785-6789
  Denver
 CCOP - Colorado Cancer Research Program
 Keren Sturtz Ph: 888-785-6789
 Colorado Blood Cancer Institute
 Keren Sturtz Ph: 888-785-6789
 Porter Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Presbyterian - St. Luke's Medical Center
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Denver Midtown
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers-Rose
 Keren Sturtz Ph: 888-785-6789
 Rose Medical Center
 Keren Sturtz Ph: 888-785-6789
 St. Joseph Hospital
 Keren Sturtz Ph: 888-785-6789
  Durango
 Mercy Medical Center
 Keren Sturtz Ph: 888-785-6789
  Englewood
 Comprehensive Cancer Care and Research Institute of Colorado LLC
 Keren Sturtz Ph: 888-785-6789
 Swedish Medical Center
 Keren Sturtz Ph: 888-785-6789
  Golden
 Mountain Blue Cancer Care Center
 Keren Sturtz Ph: 888-785-6789
  Greeley
 North Colorado Medical Center
 Keren Sturtz Ph: 888-785-6789
  Greenwood Village
 Breast Cancer Care Consultants
 Keren Sturtz Ph: 888-785-6789
  Lakewood
 Rocky Mountain Cancer Centers-Lakewood
 Keren Sturtz Ph: 888-785-6789
 St. Anthony Central Hospital
 Keren Sturtz Ph: 888-785-6789
  Littleton
 Littleton Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Littleton
 Keren Sturtz Ph: 888-785-6789
  Lone Tree
 Rocky Mountain Cancer Centers - Lone Tree
 Keren Sturtz Ph: 888-785-6789
 Sky Ridge Medical Center
 Keren Sturtz Ph: 888-785-6789
  Longmont
 Hope Cancer Care Center at Longmont United Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Longmont
 Keren Sturtz Ph: 888-785-6789
  Loveland
 McKee Medical Center
 Keren Sturtz Ph: 888-785-6789
  Parker
 Parker Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Parker
 Keren Sturtz Ph: 888-785-6789
  Pueblo
 Rocky Mountain Cancer Centers - Pueblo
 Keren Sturtz Ph: 888-785-6789
 St. Mary - Corwin Regional Medical Center
 Keren Sturtz Ph: 888-785-6789
  Thornton
 Rocky Mountain Cancer Centers - Thornton
 Keren Sturtz Ph: 888-785-6789
  Wheat Ridge
 Exempla Lutheran Medical Center
 Keren Sturtz Ph: 888-785-6789
Connecticut
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Christopher M Reynolds Ph: 734-712-3456
Florida
  Lakeland
 Lakeland Regional Cancer Center at Lakeland Regional Medical Center
 Sushma S Nakka Ph: 863-904-1900
Georgia
  Albany
 Phoebe Cancer Center at Phoebe Putney Memorial Hospital
 Jose M. Tongol Ph: 229-312-2251
  Atlanta
 Winship Cancer Institute of Emory University
 Leonard Thompson Heffner Ph: 404-778-1868
  Savannah
 Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
 Grant C Lewis Ph: 912-350-8568
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Christopher M Reynolds Ph: 734-712-3456
  Post Falls
 Kootenai Cancer Center - Post Falls
 Benjamin Thomas Marchello Ph: 800-648-6274
Illinois
  Bloomington
 Illinois CancerCare - Bloomington
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 St. Joseph Medical Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Canton
 Illinois CancerCare - Canton
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Carbondale
 Memorial Hospital of Carbondale
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Carthage
 Illinois CancerCare - Carthage
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Centralia
 Centralia Oncology Clinic
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Chicago
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Shuo Ma Ph: 312-695-1301
  Email: cancer@northwestern.edu
 University of Chicago Cancer Research Center
 Michael J Thirman Ph: 773-834-7424
  Decatur
 Cancer Care Center of Decatur
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
 Decatur Memorial Hospital Cancer Care Institute
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Effingham
 Crossroads Cancer Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Elk Grove Village
 Cancer Institute at Alexian Brothers
 Bruce B. Bank Ph: 847-952-7164
  Email: fredianc@alexian.net
  Eureka
 Illinois CancerCare - Eureka
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Galesburg
 Galesburg Clinic, PC
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 InterCommunity Cancer Center of Western Illinois
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Medical and Surgical Specialists, LLC
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Highland Park
 Hematology Oncology Associates of Illinois-Highland Park
 Shuo Ma Ph: 312-695-1301
  Email: cancer@northwestern.edu
  Kankakee
 Provena St. Mary's Regional Cancer Center - Kankakee
 Shuo Ma Ph: 312-695-1301
  Email: cancer@northwestern.edu
  Kewanee
 Illinois CancerCare - Kewanee Clinic
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Libertyville
 North Shore Oncology and Hematology Associates, Limited - Libertyville
 Shuo Ma Ph: 312-695-1301
  Email: cancer@northwestern.edu
  Macomb
 Illinois CancerCare - Macomb
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Mount Vernon
 Good Samaritan Regional Health Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
  Niles
 Cancer Care and Hematology Specialists of Chicagoland - Niles
 Shuo Ma Ph: 312-695-1301
  Email: cancer@northwestern.edu
  Normal
 Community Cancer Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Ottawa
 Illinois CancerCare - Ottawa
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Radiation Oncology of Northern Illinois
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Pekin
 Cancer Treatment Center at Pekin Hospital
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Illinois CancerCare - Pekin
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Peoria
 Illinois CancerCare - Peoria
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Methodist Medical Center of Illinois
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 OSF St. Francis Medical Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Peru
 Illinois CancerCare - Princeton
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Valley Cancer Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Princeton
 Illinois CancerCare - Princeton
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Rockford
 Advanced Care and Treatment Medical Group, PC
 Harvey Eric Einhorn Ph: 779-696-9400
  Email: cancercare@swedishamerican.org
  Skokie
 Hematology Oncology Associates - Skokie
 Shuo Ma Ph: 312-695-1301
  Email: cancer@northwestern.edu
  Springfield
 Regional Cancer Center at Memorial Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
Indiana
  Richmond
 Reid Hospital & Health Care Services
 Howard M. Gross Ph: 765-983-3000
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
 William R. Bliss Cancer Center at Mary Greeley Medical Center
 Joseph James Merchant Ph: 515-239-2621
  Boone
 McFarland Clinic PC-Boone
 Joseph James Merchant Ph: 515-239-2621
  Fort Dodge
 Trinity Regional Medical Center
 Joseph James Merchant Ph: 515-239-2621
  Jefferson
 McFarland Clinic PC-Jefferson
 Joseph James Merchant Ph: 515-239-2621
  Marshalltown
 McFarland Clinic PC-Marshalltown
 Joseph James Merchant Ph: 515-239-2621
  Mason City
 Mercy Cancer Center at Mercy Medical Center - North Iowa
 Arvind Y Vemula Ph: 800-433-3883
  Sioux City
 Mercy Medical Center - Sioux City
 Donald Bruce Wender Ph: 712-252-0088
 Siouxland Hematology-Oncology Associates, LLP
 Donald Bruce Wender Ph: 712-252-0088
 St. Luke's Regional Medical Center
 Donald Bruce Wender Ph: 712-252-0088
  Waterloo
 Covenant Cancer Treatment Center
 Mohammed T. Masri Ph: 319-272-2070
Kentucky
  Crestview Hills
 Oncology Hematology Care, Incorporated - Crestview Hills
 Howard M. Gross Ph: 765-983-3000
Maine
  Augusta
 Harold Alfond Center for Cancer Care
 Thomas Henry Openshaw Ph: 207-973-4274
  Bangor
 CancerCare of Maine at Eastern Maine Medical Center
 Thomas Henry Openshaw Ph: 207-973-4274
  Rockport
 Penobscot Bay Medical Center Cancer Care Center
 Thomas Henry Openshaw Ph: 207-973-4274
Massachusetts
  Boston
 Eastern Cooperative Oncology Group
 Tait D. Shanafelt Ph: 507-284-2358
  Email: shanafelt.tait@mayo.edu
 Tufts Medical Center Cancer Center
 Andreas K Klein Ph: 617-636-5000
  Email: ContactUsCancerCenter@TuftsMedicalCenter.org
  Worcester
 UMASS Memorial Cancer Center - University Campus
 Muthalagu Ramanathan Ph: 508-856-3216
  Email: cancer.research@umassmed.edu
Michigan
  Ann Arbor
 CCOP - Michigan Cancer Research Consortium
 Christopher M Reynolds Ph: 734-712-3456
 Saint Joseph Mercy Cancer Center
 Christopher M Reynolds Ph: 734-712-3456
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Christopher M Reynolds Ph: 734-712-3456
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Christopher M Reynolds Ph: 734-712-3456
 Wayne State University
 Jay Yang Ph: 313-576-9363
  Escanaba
 Green Bay Oncology, Limited - Escanaba
 Brian L Burnette Ph: 800-432-6049
  Farmington Hills
 Weisberg Cancer Treatment Center
 Jay Yang Ph: 313-576-9363
  Flint
 Genesys Hurley Cancer Institute
 Christopher M Reynolds Ph: 734-712-3456
 Hurley Medical Center
 Christopher M Reynolds Ph: 734-712-3456
  Iron Mountain
 Green Bay Oncology - Iron Mountain
 Brian L Burnette Ph: 800-432-6049
  Jackson
 Gayle M. Jacob Cancer Center at Allegiance Health
 Christopher M Reynolds Ph: 734-712-3456
  Kalamazoo
 West Michigan Cancer Center
 Raymond Sterling Lord Ph: 269-373-7458
  Lansing
 Sparrow Regional Cancer Center
 Christopher M Reynolds Ph: 734-712-3456
  Livonia
 St. Mary Mercy Hospital
 Christopher M Reynolds Ph: 734-712-3456
  Pontiac
 St. Joseph Mercy Oakland
 Christopher M Reynolds Ph: 734-712-3456
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Christopher M Reynolds Ph: 734-712-3456
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Christopher M Reynolds Ph: 734-712-3456
  Warren
 St. John Macomb Hospital
 Christopher M Reynolds Ph: 734-712-3456
Minnesota
  Bemidji
 MeritCare Bemidji
 Preston D. Steen Ph: 701-234-6161
  Burnsville
 Fairview Ridges Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Edina
 Fairview Southdale Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Hutchinson
 Hutchinson Area Health Care
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Maplewood
 HealthEast Cancer Care at St. John's Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Minnesota Oncology - Maplewood
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Minneapolis
 Hennepin County Medical Center - Minneapolis
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  New Ulm
 New Ulm Medical Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Robbinsdale
 Humphrey Cancer Center at North Memorial Outpatient Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Rochester
 Mayo Clinic Cancer Center
 Tait D. Shanafelt Ph: 507-538-7623
  Saint Louis Park
 CCOP - Metro-Minnesota
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Park Nicollet Cancer Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Saint Paul
 Regions Hospital Cancer Care Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 United Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Shakopee
 St. Francis Cancer Center at St. Francis Medical Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Stillwater
 Lakeview Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Waconia
 Ridgeview Medical Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Willmar
 Willmar Cancer Center at Rice Memorial Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Woodbury
 Minnesota Oncology - Woodbury
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
Missouri
  Branson
 Skaggs Cancer Center at Skaggs Regional Medical Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
  Cape Girardeau
 Saint Francis Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Joplin
 Freeman Cancer Institute at Freeman Health System
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
  Rolla
 Phelps County Regional Medical Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
  Saint Louis
 David C. Pratt Cancer Center at St. John's Mercy
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
 Mercy Clinic St. Louis Cancer and Breast Institute
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Nancy L. Bartlett Ph: 800-600-3606
  Email: info@siteman.wustl.edu
  Springfield
 Hulston Cancer Center at Cox Medical Center South
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
 St. John's Regional Health Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
Montana
  Billings
 Billings Clinic Cancer Center - 801 N 29th Street
 Benjamin Thomas Marchello Ph: 800-648-6274
 CCOP - Montana Cancer Consortium
 Benjamin Thomas Marchello Ph: 800-648-6274
 St. Vincent Healthcare Cancer Care Services
 Benjamin Thomas Marchello Ph: 800-648-6274
  Bozeman
 Bozeman Deaconess Cancer Center
 Benjamin Thomas Marchello Ph: 800-648-6274
  Butte
 St. James Healthcare Cancer Care
 Benjamin Thomas Marchello Ph: 800-648-6274
  Great Falls
 Benefis Sletten Cancer Institute
 Benjamin Thomas Marchello Ph: 800-648-6274
  Helena
 St. Peter's Hospital
 Benjamin Thomas Marchello Ph: 800-648-6274
  Kalispell
 Kalispell Regional Medical Center
 Benjamin Thomas Marchello Ph: 800-648-6274
  Missoula
 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
 Benjamin Thomas Marchello Ph: 800-648-6274
Nebraska
  Lincoln
 Cancer Resource Center - Lincoln
 Gamini S. Soori Ph: 402-280-4100
  Omaha
 Alegant Health Cancer Center at Bergan Mercy Medical Center
 Gamini S. Soori Ph: 402-280-4100
 CCOP - Missouri Valley Cancer Consortium
 Gamini S. Soori Ph: 402-280-4100
 Creighton University Medical Center
 Gamini S. Soori Ph: 402-280-4100
 Immanuel Medical Center
 Gamini S. Soori Ph: 402-280-4100
 Lakeside Hospital
 Gamini S. Soori Ph: 402-280-4100
New Hampshire
  Dover
 Seacoast Cancer Center at Wentworth - Douglass Hospital
 Taylor M Ortiz Ph: 603-740-2150
New Jersey
  East Orange
 Veterans Affairs Medical Center - East Orange
 Basil S. Kasimis Ph: 800-475-2336
  Email: patricia.goyer@med.va.gov
  Newark
 Newark Beth Israel Medical Center
 Lori Schleicher Ph: 973-926-7230
New Mexico
  Albuquerque
 University of New Mexico Cancer Center
 Cecilia Y Arana Yi Ph: 505-272-6972
New York
  Auburn
 Hematology Oncology Associates of Central New York-Auburn
 Jeffrey J. Kirshner Ph: 315-472-7504
  Liverpool
 Hematology Oncology Associates of Central New York-Liverpool
 Jeffrey J. Kirshner Ph: 315-472-7504
  Rochester
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Jonathan W Friedberg Ph: 585-275-5830
  Rome
 Hematology-Oncology Associates of New York - Rome
 Jeffrey J. Kirshner Ph: 315-472-7504
  Syracuse
 Hematology Oncology Associates of Central New York-Onondaga Hill
 Jeffrey J. Kirshner Ph: 315-472-7504
North Carolina
  Goldsboro
 Wayne Memorial Hospital, Incorporated
 James N. Atkins Ph: 919-580-0000
  Hendersonville
 Comprehensive Cancer Center at Pardee Hospital
 James E. Radford Ph: 828-696-4716
 Hendersonville Hematology and Oncology
 James E. Radford Ph: 828-696-4716
North Dakota
  Bismarck
 Medcenter One Hospital Cancer Care Center
 Preston D. Steen Ph: 701-234-6161
  Fargo
 Roger Maris Cancer Center at MeritCare Hospital
 Preston D. Steen Ph: 701-234-6161
 Preston D. Steen Ph: 701-234-6161
 Sanford Clinic North-Fargo
 Preston D. Steen Ph: 701-234-6161
Ohio
  Belpre
 Strecker Cancer Center-Belpre
 J. Philip Kuebler Ph: 614-566-3275
  Chillicothe
 Adena Regional Medical Center
 J. Philip Kuebler Ph: 614-566-3275
  Cincinnati
 Oncology Hematology Care Inc - Western Hills
 Howard M. Gross Ph: 765-983-3000
 Oncology Hematology Care, Incorporated - Anderson
 Howard M. Gross Ph: 765-983-3000
 Oncology Hematology Care, Incorporated - Blue Ash
 Howard M. Gross Ph: 765-983-3000
 Oncology Hematology Care, Incorporated - Kenwood
 Howard M. Gross Ph: 765-983-3000
 Oncology Hematology Care, Incorporated - Mt. Auburn/Taft Road
 Howard M. Gross Ph: 765-983-3000
  Columbus
 CCOP - Columbus
 J. Philip Kuebler Ph: 614-566-3275
 Columbus Oncology Associates, Incorporated
 J. Philip Kuebler Ph: 614-566-3275
 Doctors Hospital at Ohio Health
 J. Philip Kuebler Ph: 614-566-3275
 Grant Medical Center Cancer Care
 J. Philip Kuebler Ph: 614-566-3275
 Mount Carmel Health - West Hospital
 J. Philip Kuebler Ph: 614-566-3275
 Riverside Methodist Hospital Cancer Care
 J. Philip Kuebler Ph: 614-566-3275
 Zangmeister Center
 J. Philip Kuebler Ph: 614-566-3275
  Dayton
 CCOP - Dayton
 Howard M. Gross Ph: 765-983-3000
 David L. Rike Cancer Center at Miami Valley Hospital
 Howard M. Gross Ph: 765-983-3000
 Good Samaritan Hospital
 Howard M. Gross Ph: 765-983-3000
 Samaritan North Cancer Care Center
 Howard M. Gross Ph: 765-983-3000
  Delaware
 Delaware Health Center
 J. Philip Kuebler Ph: 614-566-3275
 Delaware Radiation Oncology
 J. Philip Kuebler Ph: 614-566-3275
 Grady Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Fairfield
 Oncology Hematology Care, Incorporated - Fairfield Healthplex
 Howard M. Gross Ph: 765-983-3000
  Findlay
 Blanchard Valley Regional Cancer Center
 Howard M. Gross Ph: 765-983-3000
  Franklin
 Atrium Medical Center
 Howard M. Gross Ph: 765-983-3000
  Greenville
 Wayne Hospital
 Howard M. Gross Ph: 765-983-3000
  Kettering
 Charles F. Kettering Memorial Hospital
 Howard M. Gross Ph: 765-983-3000
  Lancaster
 Fairfield Medical Center
 J. Philip Kuebler Ph: 614-566-3275
 Lancaster Radiation Oncology at Fairfield Medical Center
 J. Philip Kuebler Ph: 614-566-3275
  Marietta
 Strecker Cancer Center at Marietta Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Mount Vernon
 Knox Community Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Newark
 Licking Memorial Cancer Care Program at Licking Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
 Newark Radiation Oncology
 J. Philip Kuebler Ph: 614-566-3275
  Portsmouth
 Southern Ohio Medical Center Cancer Center
 J. Philip Kuebler Ph: 614-566-3275
  Springfield
 Community Hospital of Springfield and Clark County
 J. Philip Kuebler Ph: 614-566-3275
  Troy
 UVMC Cancer Care Center at Upper Valley Medical Center
 Howard M. Gross Ph: 765-983-3000
  Westerville
 Mount Carmel St. Ann's Cancer Center
 J. Philip Kuebler Ph: 614-566-3275
  Zanesville
 Genesis - Good Samaritan Hospital
 J. Philip Kuebler Ph: 614-566-3275
Oklahoma
  Lawton
 Cancer Centers of Southwest Oklahoma, LLC - Lawton
 Nadim F. Nimeh Ph: 877-231-4440
  Oklahoma City
 Oklahoma University Cancer Institute
 Mohamad Cherry Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Oregon
  Portland
 Kaiser Permanente Health Care - Portland
 Nagendra Tirumali Ph: 503-335-2400
Pennsylvania
  Hershey
 Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
 Michael W Evans Ph: 717-531-3779
  Email: CTO@hmc.psu.edu
  Pittsburgh
 UPMC Cancer Centers
 Alison R Sehgal Ph: 412-647-8073
  West Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Terrence P. Cescon Ph: 610-988-9323
  Williamsport
 Susquehanna Cancer Center at Divine Providence Hospital
 Warren L Robinson Ph: 800-598-4282
South Dakota
  Rapid City
 Rapid City Regional Hospital
 Mark T Schroeder Ph: 605-716-3982
  Email: research@rcrh.org
  Sioux Falls
 Avera Cancer Institute
 Addison R Tolentino Ph: 800-657-4377
  Email: Jan.Healy@avera.org
 Sanford Cancer Center at Sanford USD Medical Center
 Miroslaw A Mazurczak Ph: 605-328-1367
 Miroslaw A Mazurczak Ph: 605-328-1367
Tennessee
  Bristol
 Wellmont-Bristol Regional Medical Center
 Asheesh Shipstone Ph: 423-578-8538
  Johnson City
 Wellmont Medical Associates Oncology and Hematology-Johnson City
 Asheesh Shipstone Ph: 423-578-8538
  Kingsport
 Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
 Asheesh Shipstone Ph: 423-578-8538
 Kingsport Hematology-Oncology Associates
 Asheesh Shipstone Ph: 423-578-8538
Texas
  San Antonio
 University Hospital - San Antonio
 Anand B. Karnad Ph: 210-616-5798
 University of Texas Health Science Center at San Antonio
 Anand B. Karnad Ph: 210-616-5798
Virginia
  Martinsville
 Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
 Sreedhar Katragadda Ph: 276-666-7827
  Norton
 Southwest Virginia Regional Cancer Center at Wellmonth Health
 Asheesh Shipstone Ph: 423-578-8538
West Virginia
  Morgantown
 Mary Babb Randolph Cancer Center at West Virginia University Hospitals
 Abraham S Kanate Ph: 304-293-2745
  Email: sfilburn@hsc.wvu.edu
Wisconsin
  Antigo
 Langlade Memorial Hospital
 Hamied R. Rezazadeh Ph: 877-405-6866
  Burlington
 Aurora Cancer Care-Burlington
 Rubina Qamar Ph: 888-709-2080
  Chippewa Falls
 Marshfield Clinic - Chippewa Center
 Ali W. Bseiso Ph: 715-389-4457
  Eau Claire
 Center for Cancer Treatment & Prevention at Sacred Heart Hospital
 Ali W. Bseiso Ph: 715-389-4457
 Marshfield Clinic Cancer Care at Regional Cancer Center
 Ali W. Bseiso Ph: 715-389-4457
  Elkhorn
 Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn
 Rubina Qamar Ph: 888-709-2080
  Grafton
 Aurora Cancer Care-Grafton
 Rubina Qamar Ph: 888-709-2080
  Green Bay
 Bellin Memorial Hospital
 Patrick J Mansky Ph: 920-435-8326
 Green Bay Oncology, Limited at St. Mary's Hospital
 Brian L Burnette Ph: 800-432-6049
 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
 Brian L Burnette Ph: 800-432-6049
 St. Mary's Hospital Medical Center - Green Bay
 Brian L Burnette Ph: 800-432-6049
 St. Vincent Hospital Regional Cancer Center
 Brian L Burnette Ph: 800-432-6049
 Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
 Rubina Qamar Ph: 888-709-2080
  Kenosha
 Oncology Alliance - Kenosha South
 Rubina Qamar Ph: 888-709-2080
  La Crosse
 Gundersen Lutheran Center for Cancer and Blood
 Kurt Oettel Ph: 608-775-2385
  Email: cancerctr@gundluth.org
  Ladysmith
 Marshfield Clinic - Ladysmith Center
 Ali W. Bseiso Ph: 715-389-4457
  Manitowoc
 Holy Family Memorial Medical Center Cancer Care Center
 Brian L Burnette Ph: 800-432-6049
  Marinette
 Vince Lombardi Cancer Clinic - Marinette
 Rubina Qamar Ph: 888-709-2080
  Marshfield
 Marshfield Clinic - Marshfield Center
 Ali W. Bseiso Ph: 715-389-4457
 Saint Joseph's Hospital
 Ali W. Bseiso Ph: 715-389-4457
  Menomonee Falls
 Aurora Advanced Healthcare Inc-Menomonee Falls
 Rubina Qamar Ph: 888-709-2080
  Milwaukee
 Aurora Cancer Care-Milwaukee
 Rubina Qamar Ph: 888-709-2080
 Aurora Sinai Medical Center
 Rubina Qamar Ph: 888-709-2080
 Froedtert Hospital and Medical College of Wisconsin
 Laura C Michaelis Ph: 414-805-4380
 Oncology Alliance, SC - Milwaukee - South
 Rubina Qamar Ph: 888-709-2080
  Minocqua
 Marshfield Clinic - Lakeland Center
 Ali W. Bseiso Ph: 715-389-4457
  Mukwonago
 D.N. Greenwald Center
 Timothy R Wassenaar Ph: 262-928-7878
  New Richmond
 Cancer Center of Western Wisconsin
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Oconomowoc
 Regional Cancer Center at Oconomowoc Memorial Hospital
 Timothy R Wassenaar Ph: 262-928-7878
  Oconto Falls
 Green Bay Oncology, Limited - Oconto Falls
 Brian L Burnette Ph: 800-432-6049
  Oshkosh
 Vince Lombardi Cancer Clinic - Oshkosh
 Rubina Qamar Ph: 888-709-2080
  Racine
 Aurora Health Center - Racine
 Rubina Qamar Ph: 888-709-2080
  Rhinelander
 Ministry Medical Group at Saint Mary's Hospital
 Ali W. Bseiso Ph: 715-389-4457
 Ali W. Bseiso Ph: 715-389-4457
  Rice Lake
 Marshfield Clinic - Indianhead Center
 Ali W. Bseiso Ph: 715-389-4457
  Sheboygan
 Saint Nicholas Hospital
 Brian L Burnette Ph: 800-432-6049
 Vince Lombardi Cancer Clinic - Sheboygan
 Rubina Qamar Ph: 888-709-2080
  Stevens Point
 Marshfield Clinic at Saint Michael's Hospital
 Ali W. Bseiso Ph: 715-389-4457
 Saint Michael's Hospital Cancer Center
 Ali W. Bseiso Ph: 715-389-4457
  Sturgeon Bay
 Green Bay Oncology, Limited - Sturgeon Bay
 Brian L Burnette Ph: 800-432-6049
  Summit
 Aurora Medical Center
 Rubina Qamar Ph: 888-709-2080
  Two Rivers
 Vince Lombardi Cancer Clinic - Two Rivers
 Rubina Qamar Ph: 888-709-2080
  Waukesha
 Aurora Cancer Care-Waukesha
 Rubina Qamar Ph: 888-709-2080
 Waukesha Memorial Hospital Regional Cancer Center
 Timothy R Wassenaar Ph: 262-928-7878
  Wausau
 Marshfield Clinic - Wausau Center
 Ali W. Bseiso Ph: 715-389-4457
 University of Wisconcin Cancer Center at Aspirus Wausau Hospital
 Hamied R. Rezazadeh Ph: 877-405-6866
  Wauwatosa
 Oncology Alliance, SC - Milwaukee - West
 Rubina Qamar Ph: 888-709-2080
  West Allis
 Aurora Women's Pavilion of West Allis Memorial Hospital
 Rubina Qamar Ph: 888-709-2080
  Weston
 Diagnostic and Treatment Center
 Ali W. Bseiso Ph: 715-389-4457
 Marshfield Clinic - Weston Center
 Ali W. Bseiso Ph: 715-389-4457
 Ministry Saint Clare's Hospital
 Ali W. Bseiso Ph: 715-389-4457
  Wisconsin Rapids
 Marshfield Clinic - Wisconsin Rapids Center
 Ali W. Bseiso Ph: 715-389-4457
Wyoming
  Casper
 Rocky Mountain Oncology
 Benjamin Thomas Marchello Ph: 800-648-6274
  Sheridan
 Welch Cancer Center at Sheridan Memorial Hospital
 Benjamin Thomas Marchello Ph: 800-648-6274

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT02048813
ClinicalTrials.gov processed this data on July 22, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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