Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
523

Inclusion Criterias

Significant fatigue
Platelet count (untransfused) >= 30,000/uL
Patients may not have had major surgery within 10 days of enrollment, or minor surgery within 7 days of enrollment; examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint; the decision about whether a surgery is major or minor can be made at the discretion of the treating physician
...
Significant fatigue
Platelet count (untransfused) >= 30,000/uL
Patients may not have had major surgery within 10 days of enrollment, or minor surgery within 7 days of enrollment; examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint; the decision about whether a surgery is major or minor can be made at the discretion of the treating physician
Unintentional weight loss of 10% or more within 6 months
Patients who have had a myocardial infarction, intracranial bleed, or stroke within the past 6 months are not eligible
Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy
CLL cells on immunophenotype (performed locally) must reveal a clonal B-cell population, which express the B cell surface markers of cluster of differentiation (CD)19 and CD20, as well as the T-cell antigen CD5; patients with bright surface immunoglobulin expression or lack of CD23 expression in > 10% of cells must lack t(11;14) translocation by interphase cytogenetics
Patients must not have continued requirement for therapy with a strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitor or inducer
Patients must not have any history of Richter's transformation or prolymphocytic leukemia (prolymphocytes in blood > 55%)
Patients with class III or class IV heart failure by New York Heart Association, those with unstable angina, and those with uncontrolled arrhythmia are not eligible
Patients must not have uncontrolled active systemic infection requiring intravenous antibiotics
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Massive (>= 6 cm below the costal margin), progressive or symptomatic splenomegaly
Night sweats > 1 month without evidence of infection
Aspartate aminotransferase (AST) or alanine aminotransferase (AST) =< 2.5 x upper limits of normal except if due to disease infiltration of the liver
On morphologic review, the leukemic cells must be small mature lymphocytes, and prolymphocytes must not exceed 55% of the blood lymphocytes
Intravenous immunoglobulin (IVIG) can cause a false positive hepatitis B serology; if patients receiving routine IVIG have core antibody or surface antigen positivity without evidence of active viremia (negative hepatitis B DNA) they may still participate in the study, but should have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician
Bilirubin =< 1.5 x upper limits of normal (unless due to liver involvement, hemolysis, or Gilbert's disease)
To be calculated by modified Cockcroft-Gault formula
Patients must not have had prior therapy for CLL (except palliative steroids or treatment of autoimmune complications of CLL with rituximab or steroids)
Intermediate risk (formerly Rai stage I/II) is defined by lymphocytosis plus enlarged lymph nodes at any site, with or without hepatomegaly or splenomegaly
Patients must not have prior significant hypersensitivity to rituximab (not including infusion reactions)
Treatment with rituximab and/or high dose corticosteroids for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment; palliative steroids must be at a dose not higher than 20 mg/day of prednisone or equivalent corticosteroid at the time of registration
Patients must not be receiving active systemic anticoagulation with heparin or warfarin; patients must be off warfarin therapy for at least 30 days prior to enrollment
Absolute neutrophil count (ANC) >= 1,000/uL unless due to bone marrow involvement
Patients must not have a known allergy to mannitol
Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia or thrombocytopenia)
High risk (formerly Rai stage III/IV) is defined by lymphocytosis with or without enlarged nodes and spleen plus disease-related anemia (hemoglobin < 11 g/dL) or thrombocytopenia (platelet count < 100 x 10^9/L) that is not attributable to autoimmune hemolytic anemia or thrombocytopenia
Fevers > 100.5 degrees F for 2 weeks or more without evidence of infection
Massive nodes (>= 10 cm) or progressive or symptomatic lymphadenopathy
Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily
Patients with human immunodeficiency virus (HIV) are eligible if their CD4 count is >= 350 cells/mm^3 and if they are not taking prohibited cytochrome (CYP)-interacting medications
>= 5 x 10^9 B lymphocytes (5000/uL) in the peripheral blood

Summary

Conditions
  • Stage I Chronic Lymphocytic Leukemia
  • Stage II Chronic Lymphocytic Leukemia
  • Stage III Chronic Lymphocytic Leukemia
  • Stage IV Chronic Lymphocytic Leukemia
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 65 years and 125 years
Gender
Both males and females

Description

PRIMARY OBJECTIVES: I. To determine whether progression free survival (PFS) is superior after therapy with bendamustine (bendamustine hydrochloride) in combination with rituximab, ibrutinib alone, or ibrutinib in combination with rituximab in patients age 65 or older with previously untreated chroni...

PRIMARY OBJECTIVES: I. To determine whether progression free survival (PFS) is superior after therapy with bendamustine (bendamustine hydrochloride) in combination with rituximab, ibrutinib alone, or ibrutinib in combination with rituximab in patients age 65 or older with previously untreated chronic lymphocytic leukemia (CLL). SECONDARY OBJECTIVES: I. To determine 2-year PFS in each of the three treatment arms. II. To determine which treatment arm produces superior overall survival (OS). III. To determine the complete response (CR) rate, complete and nodular partial response (CR/nPR) rate, and overall response (PR+nPR+CR) rate (ORR) among the three treatment arms and compare these arms. IV. To determine the impact of minimal residual disease (MRD)-negative disease at time of CR documentation and at 2 years on PFS and OS in each of the treatment arms. V. To determine duration of response after each of the three treatments and compare these treatment arms. VI. To determine toxicity and tolerability of the three treatment regimens. OTHER PRE-SPECIFIED OBJECTIVES: I. To determine whether baseline cytogenetic markers, zeta-chain (TCR) associated protein kinase 70kDa (Zap-70) methylation, immunoglobulin variable region (IgVH) mutational status, or select deoxyribonucleic acid (DNA) mutations predict outcomes or time to response in these three arms. II. To determine whether local fluorescent in situ hybridization (FISH) results for del(11q22.3) and del(17p13.1) are consistent with central analysis. III. To determine whether baseline micro ribonucleic acid (RNA) and gene expression markers are correlated with clinical outcomes of interest (e.g. progression-free and alive at 2 years versus not), as well as to explore changes in microRNA expression from baseline to post-treatment time points, with a focus on those with persistent lymphocytosis and relapse. IV. To determine whether eradication of MRD predicts longer duration of response with standard therapy and ibrutinib-based regimens. V. To describe the baseline functional status, comorbid medical conditions, and number of medications of older CLL patients who meet criteria for therapy. VI. To determine how functional status changes with therapy using baseline to 3-month evaluation and end-of-study/2-year evaluation; to determine whether this change is different among the treatment groups. VII. To determine whether geriatric assessment variables known to be associated with chemotherapy toxicity in other disease groups can also predict therapy-associated toxicity in the CLL population. VIII. To assess whether the Fc fragment of IgG, low affinity IIIa, receptor (CD16a) (FCGR3A) polymorphism (rs396991) is correlated with depth of response (MRD status) to ibrutinib plus rituximab after 6 cycles, with secondary endpoints CR rate, rapidity of response, and progression-free survival (PFS). IX. To assess whether complement component 1, q subcomponent, A chain (C1QA) polymorphism (rs172378) is correlated with MRD status, CR rate, rapidity of response, and PFS. OUTLINE: Patients are randomized to 1 of 3 treatment arms. ARM I: Patients receive rituximab intravenously (IV) on day 1 (day 0 course 1) and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm II. ARM II: Patients receive ibrutinib orally (PO) daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM III: Patients receive ibrutinib as in Arm II. Patients receive rituximab IV on days 1, 8, 15, and 22 of course 2 and on day 1 of courses 3-6. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for up to 10 years.

Inclusion Criterias

Significant fatigue
Platelet count (untransfused) >= 30,000/uL
Patients may not have had major surgery within 10 days of enrollment, or minor surgery within 7 days of enrollment; examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint; the decision about whether a surgery is major or minor can be made at the discretion of the treating physician
...
Significant fatigue
Platelet count (untransfused) >= 30,000/uL
Patients may not have had major surgery within 10 days of enrollment, or minor surgery within 7 days of enrollment; examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint; the decision about whether a surgery is major or minor can be made at the discretion of the treating physician
Unintentional weight loss of 10% or more within 6 months
Patients who have had a myocardial infarction, intracranial bleed, or stroke within the past 6 months are not eligible
Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy
CLL cells on immunophenotype (performed locally) must reveal a clonal B-cell population, which express the B cell surface markers of cluster of differentiation (CD)19 and CD20, as well as the T-cell antigen CD5; patients with bright surface immunoglobulin expression or lack of CD23 expression in > 10% of cells must lack t(11;14) translocation by interphase cytogenetics
Patients must not have continued requirement for therapy with a strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitor or inducer
Patients must not have any history of Richter's transformation or prolymphocytic leukemia (prolymphocytes in blood > 55%)
Patients with class III or class IV heart failure by New York Heart Association, those with unstable angina, and those with uncontrolled arrhythmia are not eligible
Patients must not have uncontrolled active systemic infection requiring intravenous antibiotics
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Massive (>= 6 cm below the costal margin), progressive or symptomatic splenomegaly
Night sweats > 1 month without evidence of infection
Aspartate aminotransferase (AST) or alanine aminotransferase (AST) =< 2.5 x upper limits of normal except if due to disease infiltration of the liver
On morphologic review, the leukemic cells must be small mature lymphocytes, and prolymphocytes must not exceed 55% of the blood lymphocytes
Intravenous immunoglobulin (IVIG) can cause a false positive hepatitis B serology; if patients receiving routine IVIG have core antibody or surface antigen positivity without evidence of active viremia (negative hepatitis B DNA) they may still participate in the study, but should have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician
Bilirubin =< 1.5 x upper limits of normal (unless due to liver involvement, hemolysis, or Gilbert's disease)
To be calculated by modified Cockcroft-Gault formula
Patients must not have had prior therapy for CLL (except palliative steroids or treatment of autoimmune complications of CLL with rituximab or steroids)
Intermediate risk (formerly Rai stage I/II) is defined by lymphocytosis plus enlarged lymph nodes at any site, with or without hepatomegaly or splenomegaly
Patients must not have prior significant hypersensitivity to rituximab (not including infusion reactions)
Treatment with rituximab and/or high dose corticosteroids for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment; palliative steroids must be at a dose not higher than 20 mg/day of prednisone or equivalent corticosteroid at the time of registration
Patients must not be receiving active systemic anticoagulation with heparin or warfarin; patients must be off warfarin therapy for at least 30 days prior to enrollment
Absolute neutrophil count (ANC) >= 1,000/uL unless due to bone marrow involvement
Patients must not have a known allergy to mannitol
Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia or thrombocytopenia)
High risk (formerly Rai stage III/IV) is defined by lymphocytosis with or without enlarged nodes and spleen plus disease-related anemia (hemoglobin < 11 g/dL) or thrombocytopenia (platelet count < 100 x 10^9/L) that is not attributable to autoimmune hemolytic anemia or thrombocytopenia
Fevers > 100.5 degrees F for 2 weeks or more without evidence of infection
Massive nodes (>= 10 cm) or progressive or symptomatic lymphadenopathy
Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily
Patients with human immunodeficiency virus (HIV) are eligible if their CD4 count is >= 350 cells/mm^3 and if they are not taking prohibited cytochrome (CYP)-interacting medications
>= 5 x 10^9 B lymphocytes (5000/uL) in the peripheral blood

Locations

Fredericksburg, Virginia, 22401
Lone Tree, Colorado, 80124
Burien, Washington, 98166
Seattle, Washington, 98107
Royal Oak, Michigan, 48073
...
Fredericksburg, Virginia, 22401
Lone Tree, Colorado, 80124
Burien, Washington, 98166
Seattle, Washington, 98107
Royal Oak, Michigan, 48073
Geneva, Illinois, 60134
Anchorage, Alaska, 99508
Walla Walla, Washington, 99362
Loveland, Colorado, 80539
Kearney, Nebraska, 68847
Green Bay, Wisconsin, 54301
Columbus, Ohio, 43214
Independence, Kansas, 67301
Kingman, Kansas, 67068
Concord, California, 94520
Cincinnati, Ohio, 45202
Davis, California, 95616
Derry, New Hampshire, 03038
Duarte, California, 91010
Beverly, Massachusetts, 01915
Newark, Delaware, 19713
Mattoon, Illinois, 61938
Adrian, Michigan, 49221
Tacoma, Washington, 98405
Spokane Valley, Washington, 99216
Branson, Missouri, 65616
Berlin, Vermont, 05602
Bloomington, Illinois, 61701
Toledo, Ohio, 43608
Pinehurst, North Carolina, 28374
San Diego, California, 92134
Rome, New York, 13440
Winchester, Virginia, 22601
Oconto Falls, Wisconsin, 54154
Cincinnati, Ohio, 45255
Cincinnati, Ohio, 45220
Boise, Idaho, 83706
La Porte, Indiana, 46350
Hartford, Connecticut, 06105
Bardstown, Kentucky, 40004
Commerce, Michigan, 48382
Rolla, Missouri, 65401
Green Bay, Wisconsin, 54301
Clarkston, Michigan, 48346
Pekin, Illinois, 61554
Coeur d'Alene, Idaho, 83814
Concord, New Hampshire, 03301
Brevard, North Carolina, 28712
Rochester, New York, 14642
Henderson, Nevada, 89074
Antioch, California, 94531
Winston-Salem, North Carolina, 27104
Las Vegas, Nevada, 89148
Greenville, South Carolina, 29601
Danbury, Connecticut, 06810
Frederick, Maryland, 21701
Warrenville, Illinois, 60555
Zanesville, Ohio, 43701
Oconomowoc, Wisconsin, 53066
Auburn, California, 95603
Las Vegas, Nevada, 89128
Philadelphia, Pennsylvania, 19114
North Haven, Connecticut, 06473
Troy, Michigan, 48098
Prairie Village, Kansas, 66208
Dearborn, Michigan, 48126
Waukesha, Wisconsin, 53188
Liberal, Kansas, 67905
Whittier, California, 90602
Saint Louis, Missouri, 63110
Sunnyvale, California, 94086
Yelm, Washington, 98597
Richmond, California, 94801
Oakland, California, 94611
Waukesha, Wisconsin, 53188
Orlando, Florida, 32806
Papillion, Nebraska, 68046
South Bend, Indiana, 46628
Waconia, Minnesota, 55387
San Rafael, California, 94903
Waukesha, Wisconsin, 53188
Enumclaw, Washington, 98022
South San Francisco, California, 94080
Fort Scott, Kansas, 66701
Seattle, Washington, 98122-4307
Bonne Terre, Missouri, 63628
Quincy, Illinois, 62301
Burlington, Massachusetts, 01805
Greer, South Carolina, 29650
Oklahoma City, Oklahoma, 73104
Hixson, Tennessee, 37343
Moncton, New Brunswick, E1C 6Z8
Montreal, Quebec, H2X 3E4
Ottawa, Illinois, 61350
Urbana, Illinois, 61801
Amarillo, Texas, 79106
San Francisco, California, 94115
El Dorado, Kansas, 67042
Wausau, Wisconsin, 54401
Columbus, Ohio, 43219
Wichita, Kansas, 67214
Beachwood, Ohio, 44122
Chattanooga, Tennessee, 37404
Newark, Delaware, 19713
Cameron Park, California, 95682
Roseville, Michigan, 48066
Atlanta, Georgia, 30322
Michigan City, Indiana, 46360
Spencer, Iowa, 51301
Flint, Michigan, 48503
Lincoln, Nebraska, 68510
Portland, Oregon, 97225
Missoula, Montana, 59804
Kettering, Ohio, 45429
Auburn, California, 95602
Yuma, Arizona, 85364
Durango, Colorado, 81301
Tucson, Arizona, 85719
Fergus Falls, Minnesota, 56537
Elyria, Ohio, 44035
Columbus, Ohio, 43215
Kinston, North Carolina, 28501
Novato, California, 94945
Plantation, Florida, 33324
Lone Tree, Colorado, 80124
Kansas City, Missouri, 64132
Clackamas, Oregon, 97015
Durango, Colorado, 81301
Santa Clara, California, 95051
Charleston, South Carolina, 29401
Plattsburgh, New York, 12901
Decatur, Illinois, 62526
Lancaster, Ohio, 43130
Milwaukee, Wisconsin, 53233
Everett, Washington, 98201
Woodland Hills, California, 91367
Berkeley, California, 94704
Syracuse, New York, 13215
Houma, Louisiana, 70360
Warren, Michigan, 48093
Rhinelander, Wisconsin, 54501
San Antonio, Texas, 78229
Omaha, Nebraska, 68131
Las Vegas, Nevada, 89148
Jonesboro, Arkansas, 72401
Ames, Iowa, 50010
West Allis, Wisconsin, 53227
Harbor City, California, 90710
Green Bay, Wisconsin, 54301-3526
Los Angeles, California, 90034
Manhasset, New York, 11030
Anchorage, Alaska, 99508
Englewood, New Jersey, 07631
Kalispell, Montana, 59901
Rolla, Missouri, 65401
Boiling Springs, South Carolina, 29316
Carbondale, Illinois, 62902
Woodbury, Minnesota, 55125
Toledo, Ohio, 43606
Parker, Colorado, 80138
San Antonio, Texas, 78229
Newark, Ohio, 43055
Saint Cloud, Minnesota, 56303
Burbank, California, 91505
Willmar, Minnesota, 56201
Burlingame, California, 94010
Richmond, Virginia, 23230
Chardon, Ohio, 44024
Ottawa, Illinois, 61350
Walnut Creek, California, 94596
Grand Rapids, Michigan, 49503
Mishawaka, Indiana, 46545
Mount Vernon, Ohio, 43050
Buffalo, New York, 14263
Ann Arbor, Michigan, 48106
Traverse City, Michigan, 49684
Lawton, Oklahoma, 73505
Lee's Summit, Missouri, 64064
Middleburg Heights, Ohio, 44130
Derby, Connecticut, 06418
Mount Vernon, Illinois, 62864
Libertyville, Illinois, 60048
Pittsburgh, Pennsylvania, 15213
York, Pennsylvania, 17403
Centralia, Washington, 98531
Upland, Pennsylvania, 19013
Boston, Massachusetts, 02114
Gaffney, South Carolina, 29341
Duluth, Minnesota, 55805
Minneapolis, Minnesota, 55407
Kewanee, Illinois, 61443
Laconia, New Hampshire, 03246
Parkersburg, West Virginia, 26101
Cincinnati, Ohio, 45242
Grand Rapids, Michigan, 49503
Issaquah, Washington, 98029
Kansas City, Missouri, 64116
Wilmington, Delaware, 19801
Honolulu, Hawaii, 96813
Henderson, Nevada, 89052
Covington, Louisiana, 70433
Sacramento, California, 95823
Corbin, Kentucky, 40701
Lapeer, Michigan, 48446
Providence, Rhode Island, 02903
Seattle, Washington, 98112
Cody, Wyoming, 82414
Elk Grove Village, Illinois, 60007
Johnstown, Pennsylvania, 15901
Detroit, Michigan, 48202
Marion, North Carolina, 28752
Washington, District of Columbia, 20010
Burlington, Wisconsin, 53105
Las Vegas, Nevada, 89135
Omaha, Nebraska, 68122
Crestview Hills, Kentucky, 41017
Goldsboro, North Carolina, 27534
Boston, Massachusetts, 02118
Des Moines, Iowa, 50309
Des Moines, Iowa, 50314
Wilkes-Barre, Pennsylvania, 18711
Marshfield, Wisconsin, 54449
Charleston, South Carolina, 29414
Saint Paul, Minnesota, 55102
Honolulu, Hawaii, 96813
Salina, Kansas, 67401
Mountain View, California, 94040
Asheville, North Carolina, 28801
Robbinsdale, Minnesota, 55422
Cheyenne, Wyoming, 82001
Ladysmith, Wisconsin, 54848
Wynnewood, Pennsylvania, 19096
Salisbury, Maryland, 21801
Reed City, Michigan, 49677
Scranton, Pennsylvania, 18508
Lexington, Kentucky, 40504
Louisville, Kentucky, 40215
Effingham, Illinois, 62401
Lihue, Hawaii, 96766
Bellflower, California, 90706
Santa Rosa, California, 95403
Cape Girardeau, Missouri, 63703
Springfield, Illinois, 62702
Kansas City, Kansas, 66160
Las Cruces, New Mexico, 88011
Fremont, California, 94538
Billings, Montana, 59101
Richmond, Virginia, 23298
Las Vegas, Nevada, 89128
Southfield, Michigan, 48075
Charlottesville, Virginia, 22908
Ephrata, Pennsylvania, 17522
Fruitland, Idaho, 83619
Emporia, Kansas, 66801
Baton Rouge, Louisiana, 70809
Boston, Massachusetts, 02111
Shelton, Washington, 98584
Fort Collins, Colorado, 80524
Escanaba, Michigan, 49829
Providence, Rhode Island, 02906
Eau Claire, Wisconsin, 54701
Columbus, Ohio, 43228
Duluth, Minnesota, 55805
Bryn Mawr, Pennsylvania, 19010
Springfield, Illinois, 62702
Littleton, Colorado, 80122
Portland, Oregon, 97213
Washington, Pennsylvania, 15301
Anderson, South Carolina, 29621
Anchorage, Alaska, 99508
Norwalk, Connecticut, 06856
Wichita, Kansas, 67208
Norton, Virginia, 24273
Lansing, Michigan, 48910
Mukwonago, Wisconsin, 53149
Green Bay, Wisconsin, 54311
Winston-Salem, North Carolina, 27157
Delaware, Ohio, 43015
Las Vegas, Nevada, 89106
Denver, Colorado, 80220
Dodge City, Kansas, 67801
Independence, Ohio, 44131
Wichita, Kansas, 67208
'Aiea, Hawaii, 96701
Detroit, Michigan, 48236
Pittsburgh, Pennsylvania, 15232
Creston, Iowa, 50801
Tiffin, Ohio, 44883
Monmouth, Illinois, 61462
Billings, Montana, 59101
West Reading, Pennsylvania, 19611
Milwaukee, Wisconsin, 53209
Greenville, South Carolina, 29607
Boise, Idaho, 83712
Farmington Hills, Michigan, 48336
Denver, Colorado, 80218
Littleton, Colorado, 80120
Novi, Michigan, 48377
Peoria, Illinois, 61615
Stevens Point, Wisconsin, 54481
Plainsboro, New Jersey, 08536
Wisconsin Rapids, Wisconsin, 54494
Oklahoma City, Oklahoma, 73120
Boston, Massachusetts, 02215
Bozeman, Montana, 59715
Springfield, Massachusetts, 01199
Saskatoon, Saskatchewan, S7N 4H4
Honolulu, Hawaii, 96817
Seneca, Pennsylvania, 16346
Denver, Colorado, 80218
Clackamas, Oregon, 97015
Englewood, Colorado, 80113
Arroyo Grande, California, 93420
Miami, Florida, 33136
Dover, New Hampshire, 03820
Chanute, Kansas, 66720
Rehoboth Beach, Delaware, 19971
Joplin, Missouri, 64804
Portland, Oregon, 97227
Sterling Heights, Michigan, 48312
Newton, Massachusetts, 02462
Greenville, South Carolina, 29605
Effingham, Illinois, 62401
Maywood, Illinois, 60153
York, Pennsylvania, 17403
Billings, Montana, 59102
Parsons, Kansas, 67357
Columbus, Ohio, 43215
Cumberland, Maryland, 21502
Kansas City, Missouri, 64118
Nampa, Idaho, 83686
Clinton, North Carolina, 28328
Englewood, Colorado, 80113
Cincinnati, Ohio, 45219
Lake Success, New York, 11042
Great Falls, Montana, 59405
Bellevue, Washington, 98005
Edmonds, Washington, 98026
Milwaukee, Wisconsin, 53226
Greenville, South Carolina, 29615
'Aiea, Hawaii, 96701
Saint Cloud, Minnesota, 56303
Weston, Wisconsin, 54476
Calgary, Alberta, T2N 4N2
Bismarck, North Dakota, 58501
Anacortes, Washington, 98221
Cedar Rapids, Iowa, 52403
Bremerton, Washington, 98310
Vancouver, Washington, 98664
Manchester, New Hampshire, 03103
Germantown, Wisconsin, 53022
Saint Louis Park, Minnesota, 55416
Pueblo, Colorado, 81004
Greenfield Park, Quebec, J4V 2H1
Toronto, Ontario, M4N 3M5
Pittsburgh, Pennsylvania, 15243
Tulsa, Oklahoma, 74146
Springfield, Illinois, 62702
Decatur, Illinois, 62526
Princeton, Illinois, 61356
Crown Point, Indiana, 46307
Roseville, California, 95661
Fridley, Minnesota, 55432
Dayton, Ohio, 45409
Syracuse, New York, 13210
Meridian, Idaho, 83642
Elkhart, Indiana, 46514
Hampton, Virginia, 23666
Las Vegas, Nevada, 89128
Westlake, Ohio, 44145
Boone, Iowa, 50036
Asheville, North Carolina, 28801
Stillwater, Minnesota, 55082
O'Fallon, Illinois, 62269
Atlanta, Georgia, 30342
Westwood, New Jersey, 07675
Guilford, Connecticut, 06437
Seaford, Delaware, 19973
Pittsburg, Kansas, 66762
Albuquerque, New Mexico, 87110
Florence, South Carolina, 29506
Asheville, North Carolina, 28816
Torrington, Connecticut, 06790
Cincinnati, Ohio, 45242
Pueblo, Colorado, 81008
Las Vegas, Nevada, 89144
Baltimore, Maryland, 21229
Hazleton, Pennsylvania, 18201
Manchester, New Hampshire, 03102
Mount Pleasant, Michigan, 48858
Winter Park, Florida, 32792
Sioux Falls, South Dakota, 57104
Sheboygan, Wisconsin, 53081
Miami Beach, Florida, 33140
Irvine, California, 92618
Newark, New Jersey, 07112
Kingsport, Tennessee, 37660
Monroe, Michigan, 48162
Westerville, Ohio, 43081
San Diego, California, 92120
Sainte Genevieve, Missouri, 63670
Anchorage, Alaska, 99508
San Jose, California, 95124
Greensburg, Pennsylvania, 15601
Tulsa, Oklahoma, 74136
Sacramento, California, 95816
Pratt, Kansas, 67124
Dayton, Ohio, 45406
Saginaw, Michigan, 48601
Pensacola, Florida, 32504
Toledo, Ohio, 43623
Aurora, Colorado, 80012
Middletown, Connecticut, 06457
Mount Pleasant, South Carolina, 29464
Greer, South Carolina, 29651
Grand Island, Nebraska, 68803
Yorkville, Illinois, 60560
Mason City, Iowa, 50401
Clive, Iowa, 50325
Los Angeles, California, 90048
Royal Oak, Michigan, 48073
Middletown, New York, 10940
Hinsdale, Illinois, 60521
Baltimore, Maryland, 21237
Hays, Kansas, 67601
Peoria, Illinois, 61636
Jackson, Mississippi, 39216
Chippewa Falls, Wisconsin, 54729
Joliet, Illinois, 60435
South Bend, Indiana, 46601
Mishawaka, Indiana, 46545
Goldsboro, North Carolina, 27534
West Bloomfield, Michigan, 48322
Troy, Michigan, 48085
Livonia, Michigan, 48154
Jacksonville, North Carolina, 28546
Golden, Colorado, 80401
Auburn, New York, 13021
Newark, Delaware, 19713
Jefferson, Iowa, 50129
Lawrence, Kansas, 66044
Bloomington, Illinois, 61704
Kansas City, Missouri, 64108
Plymouth, Indiana, 46563
Baton Rouge, Louisiana, 70809
Augusta, Maine, 04330
Edina, Minnesota, 55435
Urbana, Illinois, 61801
Sioux City, Iowa, 51102
Asheville, North Carolina, 28803
Wauseon, Ohio, 43567
Glens Falls, New York, 12801
Cleveland, Ohio, 44111
Scottsdale, Arizona, 85259
Portland, Oregon, 97239
Longview, Washington, 98632
Bemidji, Minnesota, 56601
Kingsport, Tennessee, 37660
Chattanooga, Tennessee, 37403
Jackson, Michigan, 49201
Newmarket, Ontario, L3Y 2P9
Orlando, Florida, 32803
Paramus, New Jersey, 07652
Vallejo, California, 94589
Saint Peters, Missouri, 63376
West Chester, Pennsylvania, 19380
Denver, Colorado, 80222
Macomb, Illinois, 61455
Omaha, Nebraska, 68198
Beachwood, Ohio, 44122
Minot, North Dakota, 58701
Pottsville, Pennsylvania, 17901
Oregon, Ohio, 43616
Great Bend, Kansas, 67530
Waterford, Connecticut, 06385
Glenview, Illinois, 60026
Overland Park, Kansas, 66213
Danville, Pennsylvania, 17822
Green Bay, Wisconsin, 54303
Olathe, Kansas, 66061
West Haven, Connecticut, 06516
Las Vegas, Nevada, 89149
Kearney, Nebraska, 68845
Kankakee, Illinois, 60901
Denver, Colorado, 80205
Honolulu, Hawaii, 96813
Iowa City, Iowa, 52242
Greenville, South Carolina, 29605
New York, New York, 10032
Summit, Wisconsin, 53066
Galesburg, Illinois, 61401
Lone Tree, Colorado, 80124
Wright-Patterson Air Force Base, Ohio, 45433
Spruce Pine, North Carolina, 28777
Maumee, Ohio, 43537
Peoria, Illinois, 61637
Hamilton, Ontario, L8V 5C2
Anaheim, California, 92806
Baltimore, Maryland, 21204
Honolulu, Hawaii, 96813
Statesville, North Carolina, 28677
Orange, Connecticut, 06477
Royal Oak, Michigan, 48073
Toronto, Ontario, M5G 2M9
Sterling Heights, Michigan, 48314
Shakopee, Minnesota, 55379
State College, Pennsylvania, 16801
Mishawaka, Indiana, 46545
Montreal, Quebec, H2W 1S6
Portsmouth, New Hampshire, 03802
Eau Claire, Wisconsin, 54701
Mayfield Heights, Ohio, 44124
Green Bay, Wisconsin, 54303
Dearborn, Michigan, 48124
Lancaster, South Carolina, 29720
Denver, Colorado, 80220
Panorama City, California, 91402
Kissimmee, Florida, 34744
Denver, Colorado, 80204
San Antonio, Texas, 78229
Manitowoc, Wisconsin, 54221
Saint Louis, Missouri, 63109
Moon, Pennsylvania, 15108
Creve Coeur, Missouri, 63141
Topeka, Kansas, 66606
Jefferson City, Missouri, 65109
Grafton, Wisconsin, 53024
Charleston, South Carolina, 29414
Elkhart, Indiana, 46514-2098
'Aiea, Hawaii, 96701
Bethlehem, Pennsylvania, 18017
Columbus, Georgia, 31904
Chillicothe, Ohio, 45601
Chapel Hill, North Carolina, 27599
Martinsburg, West Virginia, 25401
Mount Clemens, Michigan, 48043
Waterbury, Connecticut, 06708
Minneapolis, Minnesota, 55417
Fort Dodge, Iowa, 50501
Brainerd, Minnesota, 56401
Hot Springs, Arkansas, 71913
Pittsburgh, Pennsylvania, 15215
Minocqua, Wisconsin, 54548
Elkhart, Indiana, 46515
East Stroudsburg, Pennsylvania, 18301
Las Vegas, Nevada, 89109
Mentor, Ohio, 44060
Brewer, Maine, 04412
Nashua, New Hampshire, 03063
Rhinelander, Wisconsin, 54501
Union, South Carolina, 29379
Tulsa, Oklahoma, 74146
Monroe, Michigan, 48162
Stony Brook, New York, 11794
Cedar Rapids, Iowa, 52403
West Columbia, South Carolina, 29169
Coon Rapids, Minnesota, 55433
Peru, Illinois, 61354
Akron, Ohio, 44307
Saint Louis Park, Minnesota, 55416
Springfield, Missouri, 65807
Battle Creek, Michigan, 49017
Cleveland, Ohio, 44106
Asheville, North Carolina, 28806
Sullivan, Missouri, 63080
Overland Park, Kansas, 66210
Las Vegas, Nevada, 89106
Media, Pennsylvania, 19063
Sacramento, California, 95825
Springfield, Missouri, 65804
Las Vegas, Nevada, 89144
Columbus, Ohio, 43210
Jupiter, Florida, 33458
Toledo, Ohio, 43617
Baton Rouge, Louisiana, 70805
South Bend, Indiana, 46601
Seattle, Washington, 98104
Bristol, Tennessee, 37620
Westville, Indiana, 46391
Pekin, Illinois, 61554
Saint Louis, Missouri, 63141
Jacksonville, Florida, 32207
Sioux City, Iowa, 51104
Fargo, North Dakota, 58122
Yakima, Washington, 98902
East Orange, New Jersey, 07018-1095
Independence, Missouri, 64057
South Hill, Virginia, 23970
Denver, Colorado, 80218
Skokie, Illinois, 60076
Flint, Michigan, 48503
Lakewood, Washington, 98499
Burnsville, Minnesota, 55337
San Francisco, California, 94115
Springfield, Ohio, 45505
Worcester, Massachusetts, 01655
Wisconsin Rapids, Wisconsin, 54494
Honolulu, Hawaii, 96817
Pittsburgh, Pennsylvania, 15237
Racine, Wisconsin, 53406
Council Bluffs, Iowa, 51503
Mountain View, California, 94040
Boston, Massachusetts, 02115
Ann Arbor, Michigan, 48106
Aurora, Illinois, 60504
Cincinnati, Ohio, 45230
Sheboygan, Wisconsin, 53081
Fargo, North Dakota, 58122
Shepherdsville, Kentucky, 40165
Greenwood Village, Colorado, 80111
Adrian, Michigan, 49221
Fitchburg, Massachusetts, 01420
Thornton, Colorado, 80260
Jacksonville, North Carolina, 28546
Newberg, Oregon, 97132
Dallas, Texas, 75390
Fresno, California, 93720
Two Rivers, Wisconsin, 54241
Hutchinson, Minnesota, 55350
Iowa City, Iowa, 52246
Joplin, Missouri, 64804
Oregon City, Oregon, 97045
Randallstown, Maryland, 21133
West Chester, Ohio, 45069
Greenville, North Carolina, 27834
Charleston, South Carolina, 29414
Peoria, Illinois, 61615
Centralia, Illinois, 62801
Gettysburg, Pennsylvania, 17325
Baldwin Park, California, 91706
Ottawa, Illinois, 61350
Columbus, Ohio, 43214
Royal Oak, Michigan, 48073
Montreal, Quebec, H2L 4M1
Fairfield, Connecticut, 06824
Butte, Montana, 59701
Aberdeen, Washington, 98520
Galesburg, Illinois, 61401
Sudbury, Ontario, P3E 5J1
New Richmond, Wisconsin, 54017
Peoria, Illinois, 61614
Longmont, Colorado, 80501
Sturgeon Bay, Wisconsin, 54235
Marietta, Ohio, 45750
Evanston, Illinois, 60201
Columbia, Missouri, 65212
Aurora, Colorado, 80012
Las Vegas, Nevada, 89121
Spokane, Washington, 99218
Sheridan, Wyoming, 82801
Cody, Wyoming, 82414
Fontana, California, 92335
Richmond, Indiana, 47374
Carthage, Illinois, 62321
Altamonte Springs, Florida, 32701
Lacey, Washington, 98503
Dayton, Ohio, 45459
Regina, Saskatchewan, S4T 7T1
Flint, Michigan, 48532
Kalamazoo, Michigan, 49007
Bangor, Maine, 04401
Walnut Creek, California, 94598
Eureka, Illinois, 61530
Grand Forks, North Dakota, 58201
Farmington Hills, Michigan, 48334
Redwood City, California, 94063
Garden City, Kansas, 67846
Sioux Falls, South Dakota, 57105
Royal Oak, Michigan, 48073
Chadds Ford, Pennsylvania, 19317
Hendersonville, North Carolina, 28791
Missoula, Montana, 59802
Las Vegas, Nevada, 89148
Michigan City, Indiana, 46360
Stockton, California, 95210
Modesto, California, 95356
Riverside, California, 92505
Rochester, Minnesota, 55905
Springfield, Illinois, 62781
Vacaville, California, 95687
Anchorage, Alaska, 99508
Chicago, Illinois, 60637
Rockford, Illinois, 61114
Bremerton, Washington, 98310
Ames, Iowa, 50010
Brownstown, Michigan, 48183
Tacoma, Washington, 98405
Clinton Township, Michigan, 48038
Baton Rouge, Louisiana, 70809
Fond Du Lac, Wisconsin, 54937
Denver, Colorado, 80218
Pawtucket, Rhode Island, 02860
Greenville, Ohio, 45331
Cedar Rapids, Iowa, 52402
Omaha, Nebraska, 68124
Palo Alto, California, 94301
Kenner, Louisiana, 70065
New Ulm, Minnesota, 56073
Royal Oak, Michigan, 48067
Denver, Colorado, 80210
Minneapolis, Minnesota, 55415
Saint Paul, Minnesota, 55101
Philadelphia, Pennsylvania, 19111
Toledo, Ohio, 43614
Lakewood, Colorado, 80228
Wheat Ridge, Colorado, 80033
McKeesport, Pennsylvania, 15132
Charleston, West Virginia, 25304
Roseville, California, 95661
Anchorage, Alaska, 99504
Fort Lauderdale, Florida, 33308
Springfield, Massachusetts, 01107
Omaha, Nebraska, 68122
Lansing, Michigan, 48912
Kenosha, Wisconsin, 53142
Las Vegas, Nevada, 89148-2405
New Britain, Connecticut, 06050
Fairfield, Ohio, 45014
Saint Louis, Missouri, 63129
Duluth, Minnesota, 55805
Huntington, West Virginia, 25702
Bellingham, Washington, 98225
Philadelphia, Pennsylvania, 19107
Maplewood, Minnesota, 55109
Utica, New York, 13502
New Orleans, Louisiana, 70121
Roseville, California, 95661
Springfield, Ohio, 45504
Lakewood, Colorado, 80228
East Syracuse, New York, 13057
Lafayette, Colorado, 80026
Allentown, Pennsylvania, 18103
Trumbull, Connecticut, 06611
Wauwatosa, Wisconsin, 53226
Birmingham, Alabama, 35233
Strongsville, Ohio, 44136
Grand Rapids, Michigan, 49503
Philadelphia, Pennsylvania, 19114
Seneca, South Carolina, 29672
Santa Cruz, California, 95065
Boulder, Colorado, 80301
Centerville, Ohio, 45459
Overland Park, Kansas, 66209
Dayton, Ohio, 45415
Sylvania, Ohio, 43560
Chicago, Illinois, 60611
Wausau, Wisconsin, 54401
Cincinnati, Ohio, 45236
Greenville, South Carolina, 29601
Seattle, Washington, 98104
Antigo, Wisconsin, 54409
Golden, Colorado, 80401
Honolulu, Hawaii, 96819
Bay City, Michigan, 48706
Albuquerque, New Mexico, 87102
Troy, Michigan, 48085
Easley, South Carolina, 29640
Winfield, Kansas, 67156
New Brunswick, New Jersey, 08903
Wellington, Kansas, 67152
Kansas City, Missouri, 64154
Milwaukee, Wisconsin, 53215
Cape Girardeau, Missouri, 63703
Marinette, Wisconsin, 54143
Kansas City, Missouri, 64111
Wooster, Ohio, 44691
Spokane, Washington, 99204
San Jose, California, 95119
Goldsboro, North Carolina, 27534
Honolulu, Hawaii, 96817
Bend, Oregon, 97701
Bridgeport, West Virginia, 26330
Pontiac, Michigan, 48341
Portsmouth, Ohio, 45662
Dallas, Texas, 75235
Gloucester, Massachusetts, 01930
Hanover, Pennsylvania, 17331
Lexington, Kentucky, 40509
Henderson, Nevada, 89074
Fort Wayne, Indiana, 46845
Henderson, Nevada, 89052
Chicago, Illinois, 60612
Mansfield, Ohio, 44906
Toronto, Ontario, M3M 0B2
Marshfield, Wisconsin, 54449
Cumming, Georgia, 30041
Bolivar, Missouri, 65613
Spartanburg, South Carolina, 29303
Orlando, Florida, 32822
Marinette, Wisconsin, 54143
Baton Rouge, Louisiana, 70809
Fargo, North Dakota, 58103
Huntington, West Virginia, 25701
Post Falls, Idaho, 83854
Greeley, Colorado, 80631
La Crosse, Wisconsin, 54601
Chesterfield, Missouri, 63017
Findlay, Ohio, 45840
Topeka, Kansas, 66606
Lynchburg, Virginia, 24501
Clive, Iowa, 50325
Las Vegas, Nevada, 89169
San Leandro, California, 94577
Newark, Delaware, 19713
Omaha, Nebraska, 68130
Coos Bay, Oregon, 97420
Pittsburgh, Pennsylvania, 15213
Bennington, Vermont, 05201
New Lenox, Illinois, 60451
Saint Helena, California, 94574
Pittsburgh, Pennsylvania, 15236
Deerfield Beach, Florida, 33442
Sunset Hills, Missouri, 63127
Lebanon, New Hampshire, 03756
Hendersonville, North Carolina, 28791
Minneapolis, Minnesota, 55454
Cincinnati, Ohio, 45247
New Haven, Connecticut, 06520
Colorado Springs, Colorado, 80907
Charleston, South Carolina, 29403
Columbus, Ohio, 43222
Delaware, Ohio, 43015
Danville, Illinois, 61832
Kokomo, Indiana, 46904
White River Junction, Vermont, 05009
Boulder, Colorado, 80304
Vacaville, California, 95687
Normal, Illinois, 61761
Twin Falls, Idaho, 83301
Ottawa, Ontario, K1H 8L6
Henderson, Nevada, 89052
Hendersonville, North Carolina, 28792
Santa Rosa, California, 95403
Honolulu, Hawaii, 96817
Rockport, Maine, 04856
Modesto, California, 95355
Duluth, Minnesota, 55805
Drexel Hill, Pennsylvania, 19026
Washington, District of Columbia, 20007
Louisville, Kentucky, 40245
Newark, Delaware, 19718
Greenbrae, California, 94904
Port Huron, Michigan, 48060
Marshalltown, Iowa, 50158
Louisville, Kentucky, 40202
Bristol, Tennessee, 37620
Des Moines, Iowa, 50314
Grosse Pointe, Michigan, 48230
Baltimore, Maryland, 21215
Peru, Illinois, 61354
Waterloo, Iowa, 50702
Novi, Michigan, 48374
York, Maine, 03909
Ephrata, Pennsylvania, 17522
Petoskey, Michigan, 49770
Rice Lake, Wisconsin, 54868
Halifax, Nova Scotia, B3H 2Y9
Longmont, Colorado, 80501
Orlando, Florida, 32803
Troy, Ohio, 45373
Kingston, Ontario, K7L 2V7
Rock Hill, South Carolina, 29732
Fargo, North Dakota, 58122
Sandusky, Ohio, 44870
Delaware, Ohio, 43015
Iron Mountain, Michigan, 49801
Oregon, Ohio, 43616
Lee's Summit, Missouri, 64086
Saint Louis, Missouri, 63131
Federal Way, Washington, 98003
Greenbrae, California, 94904
Morgantown, West Virginia, 26506
Ooltewah, Tennessee, 37363
Ridgewood, New Jersey, 07450
London, Ontario, N6A 4L6
Rapid City, South Dakota, 57701
San Marcos, California, 92078
Las Vegas, Nevada, 89113
Mayfield Heights, Ohio, 44124
Highland Park, Illinois, 60035
Durham, North Carolina, 27710
Winchester, Massachusetts, 01890
Sioux Falls, South Dakota, 57117-5134
Charleston, South Carolina, 29425
Cleveland, Ohio, 44109
Warrensville Heights, Ohio, 44122
Belpre, Ohio, 45714
Oshawa, Ontario, L1G 2B9
Uniontown, Pennsylvania, 15401
Reno, Nevada, 89503
Hershey, Pennsylvania, 17033-0850
Lewes, Delaware, 19958
Cleveland, Ohio, 44195
Beaver, Pennsylvania, 15009
Charleston, South Carolina, 29406
Milwaukie, Oregon, 97222
Maplewood, Minnesota, 55109
Casper, Wyoming, 82609
Anchorage, Alaska, 99508
Sandpoint, Idaho, 83864
Newton, Kansas, 67114
Kansas City, Kansas, 66112
Phoenix, Arizona, 85054
Franklin, Ohio, 45005-1066
Pittsburgh, Pennsylvania, 15232
Fredericksburg, Virginia, 22408
Helena, Montana, 59601
Montreal, Quebec, H3T 1E2
Troy, Michigan, 48084
Canton, Illinois, 61520
Williamsport, Pennsylvania, 17701
Wichita, Kansas, 67214
Paoli, Pennsylvania, 19301
Parker, Colorado, 80138
Cincinnati, Ohio, 45211
Colorado Springs, Colorado, 80907
Las Vegas, Nevada, 89169
Decatur, Illinois, 62526
Detroit, Michigan, 48201
Bowling Green, Ohio, 43402
Brooklyn, New York, 11219
Toledo, Ohio, 43623
Anchorage, Alaska, 99508
Las Vegas, Nevada, 89109
Lancaster, Ohio, 43130
Franklin, North Carolina, 28734
Poulsbo, Washington, 98370
Burlington, Vermont, 05405
Saint Joseph, Missouri, 64506
Salina, Kansas, 67401
Vallejo, California, 94589
Maumee, Ohio, 43537
Las Vegas, Nevada, 89119
Los Angeles, California, 90027
Weston, Wisconsin, 54476
Weston, Florida, 33331
Liberty, Missouri, 64068
Muskegon, Michigan, 49444
Weston, Wisconsin, 54476
Honolulu, Hawaii, 96826
Newark, Ohio, 43055
Vacaville, California, 95688
Tucson, Arizona, 85719
Sioux City, Iowa, 51101
Summit, New Jersey, 07902
Toronto, Ontario, M4C 3E7
Las Vegas, Nevada, 89128
Kansas City, Missouri, 64131
Lima, Ohio, 45804
West Des Moines, Iowa, 50266
Clinton, North Carolina, 28328
Oshkosh, Wisconsin, 54904
Greenville, South Carolina, 29605
Palo Alto, California, 94304
Highland Park, Illinois, 60035

Tracking Information

NCT #
NCT01886872
Collaborators
Not Provided
Investigators
  • Principal Investigator: Jennifer A Woyach Alliance for Clinical Trials in Oncology
  • Jennifer A Woyach Alliance for Clinical Trials in Oncology