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Randomized Phase III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment With Lenalidomide (Revlimid®) Alone and in Combination With Epoetin Alfa (Procrit®) in Subjects With Low- or Intermediate-1 Risk MDS and Symptomatic Anemia


Phase 3
18 Years
N/A
Not Enrolling
Both
Anemia, Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes

Thank you

Trial Information

Randomized Phase III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment With Lenalidomide (Revlimid®) Alone and in Combination With Epoetin Alfa (Procrit®) in Subjects With Low- or Intermediate-1 Risk MDS and Symptomatic Anemia


PRIMARY OBJECTIVES:

I. To compare the rate of major erythroid response (MER) in patients with low- or
intermediate-1-risk myelodysplastic syndromes treated with lenalidomide with vs without
epoetin alfa.

SECONDARY OBJECTIVES:

I. To compare the time to MER in patients treated with these regimens. II. To evaluate the
duration of MER in patients treated with these regimens. III. To estimate the frequency of
MER to salvage combination chemotherapy in patients who fail to experience an MER after
treatment with lenalidomide alone.

IV. To evaluate and compare the frequency of minor erythroid response in patients treated
with these regimens.

V. To investigate the mechanism and target of lenalidomide action in patients with
chromosome 5q31.1 deletion.

VI. To evaluate the frequency of cytogenetic response and progression, and the relationship
between cytogenetic pattern and erythroid response.

VII. To evaluate the frequency of bone marrow response (complete response and partial
response) in patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to erythropoietin
level (=< 500 mU/mL vs > 500 mU/mL) and prior erythropoietic growth factor (yes vs no).
Patients are randomized to 1 of 2 treatment arms. Patients with del 5q31.1 karyotype are
assigned to treatment arm I.

ARM I: Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21.

ARM II: Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa subcutaneously
(SC) once weekly.

In both arms, treatment repeats every 28 days for 4 courses. Patients who achieve a major
erythroid response (MER) may continue treatment beyond 4 courses in the absence of disease
progression, disease conversion to acute myeloid leukemia, or unacceptable toxicity.
Patients in arm I who fail to achieve MER or who achieve MER but relapse after 16 weeks of
treatment with lenalidomide may crossover and receive treatment in arm II.

After completion of study treatment, patients are followed for 6 months.


Inclusion Criteria:



- Documented diagnosis of 1 of the following:

- Myelodysplastic syndromes (MDS) lasting at least 3 months (MDS duration >= 3
months) according to World Health Organization (WHO) criteria or
non-proliferative chronic myelomonocytic leukemia (CMML) (white blood cells
[WBC] < 12,000/mcL)

- International prognostic scoring system (IPSS) category of low- or
intermediate-1-risk MDS as determined by cytogenetic analysis

- Cytogenetic analysis required if current bone marrow biopsy is a dry tap

- Patients with cytogenetic failure and < 10% marrow blasts are eligible

- Patients with cytogenetic failure must have prior cytogenetic results
(fluorescence in situ hybridization [FISH] is not a substitute) within 6
months after completion of the last type of MDS treatment (in this case,
growth factors are not considered a type of MDS treatment)

- Must have symptomatic anemia with hemoglobin < 9.5 g/dL =< 8 weeks prior to
randomization or with red blood cells (RBC) transfusion dependence (i.e., >= 2
units/month) confirmed for =< 8 weeks before randomization

- For patients without the deletion 5q 31.1, must have failed treatment with an
erythropoietic growth factor OR have a low probability of response to
rhu-erythropoietin, as defined by the following:

- Prior erythropoietin failure: requires ≥ 40,000 units epoetin alfa/week for 8
weeks or equivalent dose of darbepoetin alfa for 8 weeks and failed to achieve
transfusion independence (in transfusion-dependent patients) or failed to
achieve ≥ 2 g rise in hemoglobin sustained for ≥4 weeks (in
transfusion-independent patients)

- Low erythropoietin response profile: rhu-erythropoietin and epoetin alfa-naive
patients receiving ≥ 2 U pRBC/month for ≥ 8 weeks and serum erythropoietin ≥ 500
mU/mL in the 8 weeks prior to study randomization for a hemoglobin < 9.5 g/dL

- Patients must be off all non-transfusion therapy for MDS for 28 days prior to
initiation of study treatment, including all types of growth factors; patients may
receive hydrocortisone prophylactically to prevent transfusion reactions

- Patients must have a serum erythropoietin level documented before randomization and
=< 56 days before Day 1 of study treatment; NOTE: hemoglobin must be < 9.5 g/dL at
time that serum erythropoietin is drawn

- No documented iron deficiency

- Must have documented bone marrow iron stores (if marrow iron stain is not
available, transferrin saturation must be > 20% or serum ferritin > 100 ng/mL)

- Women must not pregnant or breastfeeding; females of childbearing potential must have
a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL
within 10-14 days and again within 24 hours prior to starting Cycle 1 of
lenalidomide; a female of childbearing potential(FCBP) is any woman, regardless of
sexual orientation or whether they have undergone tubal ligation, who meets the
following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or
2) has not been naturally postmenopausal for at least 24 consecutive months (i.e.,
has had menses at any time in the preceding 24 consecutive months; FCBP must also
agree to ongoing pregnancy testing

- Effective contraception must be used by patients participating in lenalidomide
therapy, and all patients must agree to counseling by a trained counselor every 28
days about pregnancy precautions and risks of fetal exposure; females of childbearing
potential (FCBP) must either commit to continued abstinence from heterosexual
intercourse or begin TWO acceptable methods of birth control: one highly effective
method and one additional effective method AT THE SAME TIME, at least 28 days before
starting lenalidomide, during lenalidomide therapy, during dose interruptions, and
for at least 28 days following childbearing potential should be referred to a
qualified provider of contraceptive methods, if needed; males receiving lenalidomide
must agree to use a latex condom during any sexual contact with females of
childbearing potential even if they have undergone a successful vasectomy

- Patients must not have prior therapy with lenalidomide

- Patients must not have a diagnosis of uncontrolled seizures or uncontrolled
hypertension

- Patients must not have proliferative (WBC >= 12,000/mcL) chronic myelomonocytic
leukemia (CMML); WBC must be < 12,000/mcL

- Patients must not have MDS secondary to treatment with radiotherapy, chemotherapy,
and/or immunotherapy for malignant or autoimmune diseases

- Platelet count >= 50,000/mcL (without platelet transfusion)

- Absolute neutrophil count (ANC) >= 500 cells/mcL (must be >= 500/mcL without myeloid
growth factor support)

- Serum creatinine =< 1.5 times upper limit of normal (ULN)

- Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) or
serum glutamic pyruvate transaminase (SGPT)/alanine aminotransferase (ALT) =< 2.0 x
ULN

- Serum total bilirubin < 3.0 mg/dL

- Prior thalidomide allowed, however, patients must not have prior >= grade-3 allergic
reactions to thalidomide

- Patients must not have prior history of desquamating rash from thalidomide at time of
study entry

- Patients must not have clinically significant anemia resulting from iron, B12 or
folate deficiencies, autoimmune or hereditary hemolysis, or gastrointestinal bleeding

- Patients must not have used cytotoxic chemotherapeutic agents or experimental agents
(agents that are not commercially available) for the treatment of MDS within 8 weeks
of randomization

- Patients must not have prior history of malignancy other than MDS (except basal cell
or squamous skin cell carcinoma or carcinoma in situ of the cervix or breast) unless
the subject has been confirmed free of disease for >= 3 years

- Patients must not have any serious medical condition or any other unstable medical
co-morbidity, or psychiatric illness that will prevent the subject from signing the
informed consent form or will place the subject at unacceptable risk if he/she
participates in the study

- Patients must not have a history of thrombo-embolic events within 3 years prior to
study randomization

- Patients must not have known human immunodeficiency virus (HIV)-1 seropositivity
because HIV can be an alternate cause of anemia

- Patients must not have a known allergic reaction to epoetin alfa (Procrit) or human
serum albumin

- Patients must have completed 16 weeks of monotherapy with lenalidomide

- Patients must show failure to achieve MER (major erythroid response) or have achieved
MER but relapsed on Arm A

- Patients must not have a limiting unresolved grade 3 or greater toxicity from
lenalidomide monotherapy or drug intolerance preventing continuation of lenalidomide
treatment

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MER defined as sustained transfusion independence in transfusion-dependent patients or a rise in hemoglobin > 2 g/dL in transfusion-independent patients with anemia for a minimum of 8 consecutive weeks

Outcome Time Frame:

At 16 weeks

Safety Issue:

No

Principal Investigator

Alan List

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-01173

NCT ID:

NCT00843882

Start Date:

January 2009

Completion Date:

Related Keywords:

  • Anemia
  • Chronic Myelomonocytic Leukemia
  • de Novo Myelodysplastic Syndromes
  • Previously Treated Myelodysplastic Syndromes
  • Anemia
  • Leukemia
  • Leukemia, Myelomonocytic, Chronic
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Acute

Name

Location

Albert Einstein College of MedicineBronx, New York  10461
Johns Hopkins UniversityBaltimore, Maryland  21205
Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Mayo ClinicRochester, Minnesota  55905
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Abington Memorial HospitalAbington, Pennsylvania  19001
University of Washington Medical CenterSeattle, Washington  98195-6043
Hurley Medical CenterFlint, Michigan  48503
Pennsylvania HospitalPhiladelphia, Pennsylvania  19107
Boulder Community HospitalBoulder, Colorado  80301-9019
Porter Adventist HospitalDenver, Colorado  80210
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
Sky Ridge Medical CenterLone Tree, Colorado  80124
North Suburban Medical CenterThornton, Colorado  80229
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Fairview Ridges HospitalBurnsville, Minnesota  55337
Hutchinson Area Health CareHutchinson, Minnesota  55350
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Avera Cancer InstituteSioux Falls, South Dakota  57105
CentraCare ClinicSaint Cloud, Minnesota  56303
Marshfield ClinicMarshfield, Wisconsin  54449
Baptist Hospital of MiamiMiami, Florida  33176-2197
Memorial Hospital of South BendSouth Bend, Indiana  46601
Marquette General HospitalMarquette, Michigan  49855
Newark Beth Israel Medical CenterNewark, New Jersey  07112
Community Medical CenterToms River, New Jersey  08755
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Virginia Mason Medical CenterSeattle, Washington  98111
Waukesha Memorial HospitalWaukesha, Wisconsin  53188
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Wesley Medical CenterWichita, Kansas  67214
Iowa Methodist Medical CenterDes Moines, Iowa  50309
Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Southern California Permanente Medical GroupDowney, California  90242
Group Health CooperativeSeattle, Washington  98112
University of Wisconsin Hospital and ClinicsMadison, Wisconsin  53792-0001
Great Falls ClinicGreat Falls, Montana  59405
Thompson Cancer Survival CenterKnoxville, Tennessee  37916
Winthrop University HospitalMineola, New York  11501
MetroHealth Medical CenterCleveland, Ohio  44109
Montefiore Medical CenterBronx, New York  10467-2490
Lewistown HospitalLewistown, Pennsylvania  17044
Mount Nittany Medical CenterState College, Pennsylvania  16803
North Colorado Medical CenterGreeley, Colorado  80631
McKee Medical CenterLoveland, Colorado  80539
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Bozeman Deaconess HospitalBozeman, Montana  59715
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Avera McKennan Hospital and University Health CenterSioux Falls, South Dakota  57105
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Welch Cancer CenterSheridan, Wyoming  82801
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Mercy Health SystemJanesville, Wisconsin  53545
Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
Elkhart General HospitalElkhart, Indiana  46515
South Bend ClinicSouth Bend, Indiana  46617
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Poudre Valley HospitalFort Collins, Colorado  80524
Beebe Medical CenterLewes, Delaware  19958
Hematology and Oncology AssociatesChicago, Illinois  60611
Community Cancer Center of MonroeMonroe, Michigan  48162
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Bismarck Cancer CenterBismarck, North Dakota  58501
Grandview HospitalDayton, Ohio  45405
Lima Memorial HospitalLima, Ohio  45804
Mercy Medical CenterSpringfield, Ohio  45504
Mercy Hospital of TiffinTiffin, Ohio  44883
Fulton County Health CenterWauseon, Ohio  43567
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Danville Regional Medical CenterDanville, Virginia  24541
Exempla Lutheran Medical CenterWheat Ridge, Colorado  80033
Mercy HospitalCoon Rapids, Minnesota  55433
Hematology Oncology Associates of Illinois-Highland ParkHighland Park, Illinois  60035
Medical Oncology and Hematology AssociatesDes Moines, Iowa  50309
Ottumwa Regional Health CenterOttumwa, Iowa  52501
Bixby Medical CenterAdrian, Michigan  49221
Saint Joseph Mercy HospitalAnn Arbor, Michigan  48106
Fairview-Southdale HospitalEdina, Minnesota  55435
Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Regions HospitalSaint Paul, Minnesota  55101
Saint Francis Regional Medical CenterShakopee, Minnesota  55379
Rice Memorial HospitalWillmar, Minnesota  56201
Saint Luke's HospitalMaumee, Ohio  43537
Geisinger Medical GroupState College, Pennsylvania  16801
Fox Valley Hematology and OncologyAppleton, Wisconsin  54911
Swedish American HospitalRockford, Illinois  61104
Center for Cancer Care and ResearchSt. Louis, Missouri  63141
Miami Valley HospitalDayton, Ohio  45409
Lawrence Memorial HospitalLawrence, Kansas  66044
Menorah Medical CenterOverland Park, Kansas  66209
Shawnee Mission Medical CenterShawnee Mission, Kansas  66204
North Kansas City HospitalKansas City, Missouri  64116
Research Medical CenterKansas City, Missouri  64132
Saint Luke's East - Lee's SummitLee's Summit, Missouri  64086
Liberty HospitalLiberty, Missouri  64068
Heartland Regional Medical CenterSaint Joseph, Missouri  64506
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Northern Montana HospitalHavre, Montana  59501
Wayne HospitalGreenville, Ohio  45331
Fisher-Titus Medical CenterNorwalk, Ohio  44857
Clinton Memorial HospitalWilmington, Ohio  45177
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
UW Cancer Center Johnson CreekJohnson Creek, Wisconsin  53038
Saint Joseph's HospitalMarshfield, Wisconsin  54449
Marshfield Clinic - Weston CenterWeston, Wisconsin  54476
Marshfield Clinic - Wisconsin Rapids CenterWisconsin Rapids, Wisconsin  54494
Rocky Mountain OncologyCasper, Wyoming  82609
Longmont United HospitalLongmont, Colorado  80501
Singing River HospitalPascagoula, Mississippi  39581
Greene Memorial HospitalXenia, Ohio  45385
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Cancer Centers of the Carolinas - Grove CommonsGreenville, South Carolina  29605
Cancer Centers of the Carolinas - SenecaSeneca, South Carolina  29672
Cancer Centers of the Carolinas - SpartanburgSpartanburg, South Carolina  29307
Mayo Clinic in ArizonaScottsdale, Arizona  85259-5404
Mayo Clinic in FloridaJacksonville, Florida  32224
Memorial Medical CenterSpringfield, Illinois  62781
Saint Francis Medical CenterGrand Island, Nebraska  68802
Guardian Oncology and Center for WellnessMissoula, Montana  59804
University of VirginiaCharlottesville, Virginia  22908
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Northwestern UniversityChicago, Illinois  60611
Elmhurst Memorial HospitalElmhurst, Illinois  60126
Bay Area HospitalCoos Bay, Oregon  97420
Hennepin County Medical CenterMinneapolis, Minnesota  
University of RochesterRochester, New York  14642
Glens Falls HospitalGlens Falls, New York  12801
Holy Cross HospitalFort Lauderdale, Florida  33308
Case Western Reserve UniversityCleveland, Ohio  44106
Wayne State UniversityDetroit, Michigan  48202
Kaiser Permanente Medical CenterVallejo, California  94589
University of Arizona Health Sciences CenterTucson, Arizona  85724
University of Massachusetts Medical SchoolWorcester, Massachusetts  01605
Mid Dakota ClinicBismarck, North Dakota  58501
Weiss Memorial HospitalChicago,, Illinois  60640
Presbyterian - Saint Lukes Medical Center - Health OneDenver, Colorado  80218
Kaiser PermanenteSacramento, California  
Montana Cancer Consortium CCOPBillings, Montana  59101
Alegent Health Immanuel Medical CenterOmaha, Nebraska  68122
Alegent Health Bergan Mercy Medical CenterOmaha, Nebraska  68124
Flower HospitalSylvania, Ohio  43560-2197
Virginia Mason CCOPSeattle, Washington  98101
Metro-Minnesota CCOPSt. Louis Park, Minnesota  
UC Davis Comprehensive Cancer CenterSacramento, California  95817
Providence HospitalSouthfield, Michigan  48075
Cancer Centers of the Carolinas - EasleyEasley, South Carolina  29640
Lakeview HospitalStillwater, Minnesota  55082
Jersey Shore Medical CenterNeptune, New Jersey  07754
Decatur Memorial HospitalDecatur, Illinois  62526
Frederick Memorial HospitalFrederick, Maryland  21701
Lankenau HospitalWynnewood, Pennsylvania  19096
Princeton Community HospitalPrinceton, West Virginia  24740
Montana Cancer SpecialistsMissoula, Montana  59807-7877
Phoenixville HospitalPhoenixville, Pennsylvania  19460
University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Penn State Milton S Hershey Medical CenterHershey, Pennsylvania  17033
Southeast Cancer CenterCape Girardeau, Missouri  63703
Butler Memorial HospitalButler, Pennsylvania  16001
Parker Adventist HospitalParker, Colorado  80138
Froedtert and the Medical College of WisconsinMilwaukee, Wisconsin  53226
Saint Helena HospitalSaint Helena, California  94574
Leesburg Regional Medical CenterLeesburg, Florida  34748
Fremont - Rideout Cancer CenterMarysville, California  95901
The Medical Center of AuroraAurora, Colorado  80012
Penrose-Saint Francis HealthcareColorado Springs, Colorado  80907
Saint Anthony Central HospitalDenver, Colorado  80204
Exempla Saint Joseph HospitalDenver, Colorado  80218
Colorado Cancer Research Program CCOPDenver, Colorado  80224-2522
Saint Mary's Hospital and Regional Medical CenterGrand Junction, Colorado  81502
Saint Mary Corwin Medical CenterPueblo, Colorado  81004
Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
The Hospital of Central ConnecticutNew Britain, Connecticut  06050
Edna Williams Cancer Center at the Baptist Cancer InstituteJacksonville, Florida  32207
Saint Luke's Mountain States Tumor InstituteBoise, Idaho  83712
Resurrection HealthcareChicago, Illinois  60631
Saint Francis HospitalEvanston, Illinois  60202
Evanston CCOP-NorthShore University HealthSystemEvanston, Illinois  60201
Joliet Oncology-Hematology Associates LimitedJoliet, Illinois  60435
Midwest Center for Hematology OncologyJoliet, Illinois  60432
North Shore Hematology OncologyLibertyville, Illinois  60048
Hematology Oncology Associates of Illinois - SkokieSkokie, Illinois  60076
Saint Francis Hospital and Health CentersBeech Grove, Indiana  46107
Fort Wayne Medical Oncology and Hematology Inc - State BoulevardFort Wayne, Indiana  46845
Premier Oncology Hematology AssociatesMerrillville, Indiana  46410
Reid Hospital and Health Care ServicesRichmond, Indiana  47374
McFarland ClinicAmes, Iowa  50010
Cedar Rapids Oncology AssociationCedar Rapids, Iowa  52403
Mercy HospitalCedar Rapids, Iowa  52403
Medical Oncology and Hematology Associates-West Des MoinesClive, Iowa  50325
Iowa Oncology Research Association CCOPDes Moines, Iowa  50309
Mercy CapitolDes Moines, Iowa  50307
Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates-Des MoinesDes Moines, Iowa  50309
Mercy Medical Center - North IowaMason City, Iowa  50401
Mercy Medical Center-Sioux CitySioux City, Iowa  51104
Saint Luke's Regional Medical CenterSioux City, Iowa  51104
Caritas Saint Elizabeth's Medical CenterBrighton, Massachusetts  02135-2997
Holy Family HospitalMethuen, Massachusetts  01844
Hickman Cancer CenterAdrian, Michigan  49221
Michigan Cancer Research Consortium Community Clinical Oncology ProgramAnn Arbor, Michigan  48106
Oakwood HospitalDearborn, Michigan  48123
Saint John Hospital and Medical CenterDetroit, Michigan  48236
Green Bay Oncology - EscanabaEscanaba, Michigan  49431
Green Bay Oncology - Iron MountainIron Mountain, Michigan  49801
Allegiance HealthJackson, Michigan  49201
Sparrow HospitalLansing, Michigan  48912
Saint Mary Mercy HospitalLivonia, Michigan  48154
Mercy Memorial HospitalMonroe, Michigan  48162
Saint Joseph Mercy OaklandPontiac, Michigan  48341-2985
Saint Joseph Mercy Port HuronPort Huron, Michigan  48060
Saint Mary's of MichiganSaginaw, Michigan  48601
Lakeland HospitalSt. Joseph, Michigan  49085
Saint John Macomb-Oakland HospitalWarren, Michigan  48093
Medini, Eitan MD (UIA Investigator)Alexandria, Minnesota  56308
Unity HospitalFridley, Minnesota  55432
Saint John's Hospital - HealtheastMaplewood, Minnesota  55109
Minnesota Oncology Hematology PA-MaplewoodMaplewood, Minnesota  55109
Minneapolis Veterans Medical CenterMinneapolis, Minnesota  55417
North Memorial Medical Health CenterRobbinsdale, Minnesota  55422
Saint Cloud HospitalSaint Cloud, Minnesota  56303
Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, Minnesota  55416
Minnesota Oncology and Hematology PA-WoodburyWoodbury, Minnesota  55125
Keesler Medical CenterKessler AFB, Mississippi  39534
Kansas City Veterans Affairs Medical CenterKansas City, Missouri  64128
Saint Luke's Cancer InstituteKansas City, Missouri  64111
Saint Luke's Hospital of Kansas CityKansas City, Missouri  64111
Saint Joseph Health CenterKansas City, Missouri  64114
Liberty Radiation Oncology ClinicKansas City, Missouri  64116
Truman Medical CenterKansas City, Missouri  64108
Missouri Baptist Medical CenterSaint Louis, Missouri  63131
Saint John's HospitalSpringfield, Missouri  65804
Hematology-Oncology Centers of the Northern Rockies PCBillings, Montana  59101
Saint Vincent HealthcareBillings, Montana  59101
Billings ClinicBillings, Montana  59107-7000
Saint James Community Hospital and Cancer Treatment CenterButte, Montana  59701
Benefis Healthcare- Sletten Cancer InstituteGreat Falls, Montana  59405
Berdeaux, Donald MD (UIA Investigator)Great Falls, Montana  59405
Saint Peter's Community HospitalHelena, Montana  59601
Glacier Oncology PLLCKalispell, Montana  59901
Saint Patrick Hospital - Community HospitalMissoula, Montana  59802
Lincoln Medical Education Foundation Cancer Resource CenterLincoln, Nebraska  68510
Missouri Valley Cancer Consortium CCOPOmaha, Nebraska  68106
Nevada Cancer Research Foundation CCOPLas Vegas, Nevada  89106
Cheshire Medical Center-Dartmouth-Hitchcock KeeneKeene, New Hampshire  03431
Cooper Hospital University Medical CenterCamden, New Jersey  08103
Veterans Adminstration New Jersey Health Care SystemEast Orange, New Jersey  07018-1095
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington CountyMount Holly, New Jersey  08060
South Jersey HealthcareVineland, New Jersey  08360
Virtua West Jersey Hospital VoorheesVoorhees, New Jersey  08043
Orange Regional Medical CenterMiddletown, New York  10940
New York University Langone Medical CenterNew York, New York  10016
Highland HospitalRochester, New York  14620
Mission Hospitals IncAsheville, North Carolina  28801
Wayne Memorial HospitalGoldsboro, North Carolina  27534
Saint Alexius Medical CenterBismarck, North Dakota  58501
Aultman Health FoundationCanton, Ohio  44710
Good Samaritan Hospital - DaytonDayton, Ohio  45406
Dayton CCOPDayton, Ohio  45429
Samaritan North Health CenterDayton, Ohio  45415
Hematology Oncology Center IncorporatedElyria, Ohio  44035
Blanchard Valley HospitalFindlay, Ohio  45840
Atrium Medical Center-Middletown Regional HospitalFranklin, Ohio  45005-1066
Kettering Medical CenterKettering, Ohio  45429
Saint Rita's Medical CenterLima, Ohio  45801
Toledo Radiation Oncology at Northwest Ohio Onocolgy CenterMaumee, Ohio  43537
Saint Charles HospitalOregon, Ohio  43616
North Coast Cancer CareSandusky, Ohio  44870
Toledo Community Hospital Oncology Program CCOPToledo, Ohio  43617
Mercy Cancer Center at Saint Anne Mercy HospitalToledo, Ohio  43623
University of ToledoToledo, Ohio  43614
Saint Vincent Mercy Medical CenterToledo, Ohio  43608
Upper Valley Medical CenterTroy, Ohio  45373
Ephrata Cancer CenterEphrata, Pennsylvania  17522
Riddle HospitalMedia, Pennsylvania  19063
Geisinger Wyoming ValleyWilkes-Barre, Pennsylvania  18711
Mainline Health CCOPWynnewood, Pennsylvania  19096
Greenville CCOPGreenville, South Carolina  29615
Greenville Memorial HospitalGreenville, South Carolina  29605
The Don and Sybil Harrington Cancer CenterAmarillo, Texas  79106
Fredericksburg Oncology IncFredericksburg, Virginia  22401
Harrison Bremerton Hematology and OncologyBremerton, Washington  98310
Columbia Basin Hematology and Oncology PLLCKennewick, Washington  99336
Evergreen Hospital Medical CenterKirkland, Washington  98033
Minor and James Medical PLLCSeattle, Washington  98104
Swedish Medical Center-First HillSeattle, Washington  98122-4307
West Virginia UniversityMorgantown, West Virginia  26506
Saint Vincent HospitalGreen Bay, Wisconsin  54301
Green Bay Oncology Limited at Saint Mary's HospitalGreen Bay, Wisconsin  54303
Saint Mary's HospitalGreen Bay, Wisconsin  54303
Green Bay Oncology at Saint Vincent HospitalGreen Bay, Wisconsin  54301-3526
Aurora BayCare Medical CenterGreen Bay, Wisconsin  54311-6519
Dean Hematology and Oncology ClinicMadison, Wisconsin  53717
Vince Lombardi Cancer Clinic-MarinetteMarinette, Wisconsin  54143
Bay Area Medical CenterMarinette, Wisconsin  54143
Marshfield Clinic-Minocqua CenterMinocqua, Wisconsin  54548
Oconomowoc Memorial Hospital-ProHealth Care IncOconomowoc, Wisconsin  53066-3896
Green Bay Oncology - Oconto FallsOconto Falls, Wisconsin  54154
Marshfield Clinic at James Beck Cancer CenterRhinelander, Wisconsin  54501
Marshfield Clinic-Rice Lake CenterRice Lake, Wisconsin  54868
Saint Michael's HospitalStevens Point, Wisconsin  54481
Green Bay Oncology - Sturgeon BaySturgeon Bay, Wisconsin  54235
Aspirus Regional Cancer CenterWausau, Wisconsin  54401
University of Maryland Greenebaum Cancer CenterBaltimore, Maryland  21201
Jupiter Medical CenterJupiter, Florida  33458
Elkhart ClinicElkhart, Indiana  46515
Memorial Healthcare System - Joe DiMaggio Children's HospitalHollywood, Florida  33021
Mount Sinai Medical Center CCOPMiami Beach, Florida  33140
Michiana Hematology Oncology PC-ElkhartElkhart, Indiana  46514
Michiana Hematology Oncology PC-PlymouthPlymouth, Indiana  46563
Michiana Hematology Oncology PC-South BendSouth Bend, Indiana  46601
Michiana Hematology Oncology-PC WestvilleWestville, Indiana  46391
Saint Agnes HospitalBaltimore, Maryland  21229
University of Michigan University HospitalAnn Arbor, Michigan  48109
Michiana Hematology Oncology PC-NilesNiles, Michigan  49120
University of Missouri - Ellis FischelColumbia, Missouri  65203
Rex Cancer CenterRaleigh, North Carolina  27607
North Coast Cancer Care-ClydeClyde, Ohio  43410
Community Health Partners Regional Medical CenterElyria, Ohio  44035
Cancer Centers of the Carolinas - FarisGreenville, South Carolina  29605
Cancer Centers of the Carolinas-Greer Radiation OncologyGreer, South Carolina  29650
Cancer Centers of the Carolinas-Greer Medical OncologyGreer, South Carolina  29650
Skagit Valley HospitalMt. Vernon, Washington  98273
Evergreen Hematology and Oncology PSSpokane, Washington  99218
Marshfield Clinic-Chippewa CenterChippewa Falls, Wisconsin  54729
Holy Family Memorial HospitalManitowoc, Wisconsin  54221
Vince Lombardi Cancer Clinic-SheboyganSheboygan, Wisconsin  53081
Marshfield Clinic Cancer Care at Saint Michael's HospitalStevens Point, Wisconsin  54481
Aurora Medical Center in SummitSummit, Wisconsin  53066
Vince Lombardi Cancer ClinicTwo Rivers, Wisconsin  54241
Riverview HospitalWisconsin Rapids, Wisconsin  54494
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, Florida  33136
Arizona Cancer Center at University Medical Center NorthTucson, Arizona  85719
Saint Luke's Mountain States Tumor Institute - FruitlandFruitland, Idaho  83619
Kaiser Anaheim Medical CenterAnaheim, California  92807
Kaiser Permanente Medical Group - Baldwin ParkBaldwin Park, California  91706
Kaiser Foundation HospitalBellflower, California  90706
Kaiser Permanente HospitalFontana, California  92335
Kaiser Permanente - Harbor CityHarbor City, California  90710
Kaiser Permanente-West Los AngelesLos Angeles, California  90034
Kaiser Permanente - Panorama CityPanorama City, California  91402
Kaiser Permanente at San DiegoSan Diego, California  92120
Kaiser Permanente Health CareSan Marcos, California  92069
Saint Luke's Mountain States Tumor Institute - MeridianMeridian, Idaho  83642
Saint Luke's Mountain States Tumor Institute - NampaNampa, Idaho  83686
Central DuPage Hospital Cancer CenterWarrenville, Illinois  60555
Saint Luke's South HospitalOverland Park, Kansas  66213
Kansas City CCOPPrairie Village, Kansas  66208
King's Daughter's Medical CenterAshland, Kentucky  41101
Capital Region Medical Center-Goldschmidt Cancer CenterJefferson City, Missouri  65109
Heartland Hematology and Oncology Associates IncorporatedKansas City, Missouri  64118
Saint Joseph Oncology IncSaint Joseph, Missouri  64507
Comprehensive Cancer Care PCSaint Louis, Missouri  63141
Susquehanna Cancer CenterWilliamsport, Pennsylvania  17701
Memorial Hospital Of MartinsvilleMartinsville, Virginia  24115
Pacific Medical Center-First HillSeattle, Washington  98104
Gundersen LutheranLa Crosse, Wisconsin  54601
Saint Nicholas HospitalMadison, Wisconsin  53715
Fairbanks Memorial HospitalFairbanks, Alaska  99701
Stanford University Hospitals and ClinicsStanford, California  94305
Siouxland Hematology Oncology AssociatesSioux City, Iowa  51101
Walter Reed National Military Medical CenterBethesda, Maryland  20889
Kaiser Permanente-MissionSan Diego, California  92108
IU Health ArnettLafayette, Indiana  
Michiana Hematology Oncology PC-MishawakaMishawaka, Indiana  46545-1470
Oncology Associates at Mercy Medical CenterCedar Rapids, Iowa  52403
Marie Yeager Cancer CenterSaint Joseph, Michigan  49085
Hematology Oncology Associates of Central New York PCEast Syracuse, New York  13057
Door County Cancer CenterSturgeon Bay, Wisconsin  54235-1495
The Toledo Hospital/Toledo Children's HospitalToledo, Ohio  43606
Genesys Regional Medical Center-West Flint CampusFlint, Michigan  48532
Sanford Bismarck Medical CenterBismarck, North Dakota  58501
Toledo Clinic Cancer Centers-OregonOregon, Ohio  43616
Geisinger Medical Center-Cancer Center HazeltonHazleton, Pennsylvania  18201
Presbyterian Intercommunity HospitalWhittier, California  90602
Community Howard Regional HealthKokomo, Indiana  46904
Indiana University Health La Porte HospitalLa Porte, Indiana  46350
Saint Joseph Regional Medical Center-MishawakaMishawaka, Indiana  46545-1470
PeaceHealth Saint Joseph Medical CenterBellingham, Washington  98225
Christiana Care Health System-Christiana HospitalNewark, Delaware  19718
Illinois Cancer Specialists-NilesNiles, Illinois  60714
Riverview Medical Center/Booker Cancer CenterRed Bank, New Jersey  07701
Georgia Regents UniversityAugusta, Georgia  30912
Marin Cancer Care IncGreenbrae, California  94904
Toledo Clinic Cancer Centers-Bowling GreenBowling Green, Ohio  43402
Toledo Clinic Cancer Centers-MaumeeMaumee, Ohio  43537-1839
Toledo Clinic Cancer Centers-ToledoToledo, Ohio  43623
Self Regional HealthcareGreenwood, South Carolina  29646
Harrison Poulsbo Hematology and OncologyPoulsbo, Washington  98370
Aurora Cancer Care-Southern LakesElkhorn, Wisconsin  53121
Saint Luke's Mountain States Tumor Institute-Twin FallsTwin Falls, Idaho  83301
D N Greenwald CenterMukwonago, Wisconsin  53149
Presence Saint Mary's HospitalKankakee, Illinois  60901
Rex Cancer Center of WakefieldRaleigh, North Carolina  27614
Marshfield Clinic Cancer Center at Sacred HeartEau Claire, Wisconsin  54701