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Studying Interventions for Managing Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase: The 5-Year Prospective Cohort Study (SIMPLICITY)


N/A
18 Years
N/A
Open (Enrolling)
Both
Chronic Myeloid Leukemia

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Trial Information

Studying Interventions for Managing Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase: The 5-Year Prospective Cohort Study (SIMPLICITY)


Time Perspective : Most patients are expected to be a mix of retrospective and prospective
data collection. Patients can be enrolled after their study index date (retrospective
component) and have to be followed until 5 years from study index date are complete (time
between enrollment and 5 year follow-up is the prospective component)


Inclusion Criteria:



- Newly-diagnosed chronic phase chronic myeloid leukemia (CP-CML) patients who started
their first-line Tyrosine Kinase Inhibitor (TKI) treatment on imatinib, dasatinib or
nilotinib in accordance with the timelines below

- 18 years or older at time of of CP-CML diagnosis

a) Imatinib Cohorts

- Patients who started their first-line Imatinib treatment between January 2, 2008 and
September 30, 2010.Patients fitting this criterion are defined as retrospective
Imatinib patients

− Patients who started their first-line Imatinib treatment on or after October 1,
2010

b) Dasatinib Cohort

- Patients who started their first-line Dasatinib treatment after the drug was approved
in this indication

c) Nilotinib Cohort

- Patients who started their first-line Nilotinib treatment after the drug was approved
in this indication

- Patients are also eligible when they have already switched to a subsequent therapy
(TKI or other) at the time of enrollment, as long as their first-line and subsequent
CML treatment information is available at site for data entry into the study
Electronic Case Report Form (eCRF)

- Receiving treatment at medical practice (eg. community-based, office-based,
hospital-based, academic setting, oncology center)

Exclusion Criteria:

- Patients who are participating in an interventional trial which may influence the
management of their CML disease will be excluded

Discontinuation Criteria:

- Enrolled patients who join an interventional trial which may influence the management
of their CML disease will be excluded at the time of entry into the interventional
trial

Type of Study:

Observational

Study Design:

Observational Model: Cohort

Outcome Measure:

The rate of Complete Cytogenetic Response

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Institutional Review Board

Study ID:

CA180-330

NCT ID:

NCT01244750

Start Date:

October 2010

Completion Date:

December 2017

Related Keywords:

  • Chronic Myeloid Leukemia
  • Chronic Phase - Chronic Myeloid Leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Akron General Medical CenterAkron, Ohio  44302
Lehigh Valley HospitalAllentown, Pennsylvania  18103
Michigan State UniversityEast Lansing, Michigan  48824
Hackensack University Medical CenterHackensack, New Jersey  07601
Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Thompson Cancer Survival CenterKnoxville, Tennessee  37916
Central Baptist HospitalLexington, Kentucky  40503
Vassar Brothers Medical CenterPoughkeepsie, New York  12601
Providence Cancer Center at Sacred Heart Medical CenterSpokane, Washington  99220-2555
Charleston Area Medical CenterCharleston, West Virginia  25304
Florida Cancer SpecialistsFort Myers, Florida  33901
Carle Cancer CenterUrbana, Illinois  61801
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Rocky Mountain Cancer CentersThornton, Colorado  80260
Watson ClinicLakeland, Florida  33805
Indiana Blood and Marrow TransplantationIndianapolis, Indiana  46202
Genesis Cancer CenterHot Springs, Arkansas  71913
Tennessee Cancer SpecialistsKnoxville, Tennessee  37920
Oregon Health & Science UniversityPortland, Oregon  97201
Duke University Medical CenterDurham, North Carolina  27710
Cancer Care AssociatesTulsa, Oklahoma  74136
University of FloridaGainesville, Florida  32610-0277
Georgia Cancer SpecialistMarietta, Georgia  30060
Emory UniversityAtlanta, Georgia  30322
Charleston Cancer CenterCharleston, South Carolina  29406
Broward Oncology AssociatesFt. Lauderdale, Florida  33308
Consultants in Blood DisordersLouisville, Kentucky  40207
Cancer Centers of FloridaOrlando, Florida  32806
Stony Brook University HospitalStony Brook, New York  11794-8174
St. Luke's Hospital and Health NetworkBethlehem, Pennsylvania  18015
Texas OncologyDallas, Texas  
George Washington UniversityWashington, District of Columbia  20037
North Texas Regional Cancer CenterPlano, Texas  75075
Gabrail Cancer CenterCanton, Ohio  44718
Avera Research InstituteSioux Falls, South Dakota  57105
Cancer & Hematology Centers of Western MichiganGrand Rapids, Michigan  49546
Hematology-Oncology Associates of Northern NJ, PAMorristown, New Jersey  07962
Medical Oncology Associates of Wyoming Valley, PCKingston, Pennsylvania  18704
Frederick Memorial HospitalFrederick, Maryland  21701
Peninsula Cancer InstituteNewport News, Virginia  23601
Broome OncologyJohnson City, New York  13790
Little Rock Hematology Oncology AssociatesLittle Rock, Arkansas  72205
University of Southern CaliforniaLos Angeles, California  90033
Billings ClinicBillings, Montana  59107-7000
Portsmouth Regional HospitalPortsmouth, New Hampshire  03802
Wheeling HospitalWheeling, West Virginia  26003
Aspirus Regional Cancer CenterWausau, Wisconsin  54401
Cancer Center of KansasWichita, Kansas  67214
Baptist Cancer InstituteJacksonville, Florida  32207
Northwest Alabama Cancer CenterMuscle Shoals, Alabama  35661
Cancer Care Centers of South TexasSan Antonio, Texas  78229
Investigative Clinical Research of IndianaIndianapolis, Indiana  46254
Cancer Outreach AssociatesAbingdon, Virginia  24211
University of Tennessee Medical CenterKnoxville, Tennessee  37920
Yakima Valley Memorial Hospital/North Star LodgeYakima, Washington  98902
Delnor Community HospitalGeneva, Illinois  60134
East Carolina UniversityGreenville, North Carolina  27858
Texas Oncology-Austin NorthAustin, Texas  78759
Southwest Cancer Care Medical GroupPoway, California  92064-2527
Stockton Hematology OncologyStockton, California  95204
Waverly Hematology OncologyCary, North Carolina  27518
Pacific Cancer Medical Center, IncAnaheim, California  92801
Northwest Georgia Oncology Centers, PCMarietta, Georgia  30060
Baptist Cancer CenterJacksonville, Florida  32209
Signal Point Clinical Research Center, LLCMiddletown, Ohio  45042
Blue Ridge Cancer CareRoanoke, Virginia  24019
Geisinger Health SystemWilkes Barre, Pennsylvania  18711
Wilshire Oncology Medical Group, IncLaVerne, California  91750
Palm Springs Research InstituteHialeah, Florida  33012
Boston VA Healthcare SystemBoston, Massachusetts  02130
Danville Hematology & OncologyDanville, Virginia  24541
Hutchinson ClinicHutchinson, Kansas  67502
Lake County Oncology and HematologyThe Villages, Florida  32159
Texas Oncology - Arlington SouthArlington, Texas  76014-2084
Central DuPage HospitalWinfield, Illinois  60190
North Chicago VA Medical CenterNorth Chicago, Illinois  60064
Cotton O'Neil Cancer CenterTopeka, Kansas  66606
Maryland Oncology Hematology PAColumbia, Maryland  21044
Omaha VAMCOmaha, Nebraska  68105
NEA Baptist ClinicJonesboro, Arkansas  72401
Arizona Oncology Associates, PC - NAHOASedona, Arizona  86336
Arizona Oncology Associates, PC - HOPETucson, Arizona  85704
Texas Oncology-Methodist Charlton Cancer CenterDallas, Texas  75237
Texas Oncology-Dallas Presbyterian HospitalDallas, Texas  75231
Texas Oncology-Midland Allison Cancer CenterMidland, Texas  79701
Medical Oncology and Blood Disorders, LLPManchester, Connecticut  06040
Space Coast Cancer CenterTitusville, Florida  32796
St. Joseph's HospitalOrange, California  92868
PMK Medical Group, Inc. DBA VenturaOxnard, California  93030
Tahoe Forest Health System Cancer CenterTruckee, California  96160
Washington Hospital Center, Washington Cancer InstituteWashington D.C, District of Columbia  20010
Hematology And Medical Oncology Of Southern Palm Beach CountyBoynton Beach, Florida  33435
Peachtree Hematology-OncologyAtlanta, Georgia  30318
Straub Clinical & HospitalHonolulu, Hawaii  96813
OnCareHonolulu, Hawaii  96813
Kaiser Permanente HonoluluHonolulu, Hawaii  96819
Mahafzah Medical CenterEvergreen Park, Illinois  60805
Orchard Health Care ResearchNiles, Illinois  60076
Mid-Illinois Hem/Onc AsocNormal, Illinois  61761
Saint John's Cancer CenterAnderson, Indiana  46016
Horizon Oncology Research, IncLafayette, Indiana  47905
Cancer Care Center, Inc. PCNew Albany, Indiana  47150
N. Iowa Mercy Cancer CenterMason City, Iowa  50401
University of Louisville Hospital - Brown Cancer CenterLouisville, Kentucky  40202
Willis-Knighton Cancer SystemShreveport, Louisiana  71103
Sturdy Hematology & Oncology AssociatesAttleboro, Massachusetts  02703
Commonwealth Hematology-Oncology, P.C.Quincy, Massachusetts  02169
UMass Medical CenterWorcester, Massachusetts  01655
St John's Clinic for Cancer and HematologySpringfield, Missouri  65807
Southern Oncology HematologyVineland, New Jersey  08360
Montefiore Medical Center / AECOMBronx, New York  10467
Advanced OncologyNew York, New York  10013
St. Lukes Roosevelt Medical CenterNew York, New York  10019
Alamance Regional Cancer CenterBurlington, North Carolina  27215
Gaston Hematology OncologyGastonia, North Carolina  28054
Medical Center of NewarkNewark, Ohio  43055
Hematology/Oncology Salem LLPSalem, Oregon  97301
Lancaster General HealthLancaster, Pennsylvania  17601
Veterans Research Foundation of PittsburghPittsburgh, Pennsylvania  15240
Berks Hematology-OncologyWest Reading, Pennsylvania  19611
Cancer Care Association Of YorkYork, Pennsylvania  17403
Hematology and Oncology Associates of RICranston, Rhode Island  02920
The Cancer Center at Memorial HospitalPawtucket, Rhode Island  02860
Prairie Lakes Healthcare System, IncWatertown, South Dakota  57201
Integrity OncologyMemphis, Tennessee  38120
Julie & Ben Rogers Cancer InstituteBeaumont, Texas  77701
Texas Oncology-Medical City DallasDallas, Texas  75230-2510
Michael DeBakey VA Medical CenterHouston, Texas  77030
Texas Oncology-McAllen South SecondMcAllen, Texas  78503
Texas Oncology-Odessa West Texas Cancer CenterOdessa, Texas  79761
Hematology Oncology Associates of FredricksburgFredericksburg, Virginia  22408
Swedish Cancer Institute-Eastside Hematology/OncologyBellevue, Washington  98005
City Hospital - West Virginia University Hospital EastMartinsburg, West Virginia  25401
Arizona Oncology Associates, PC - HALPhoenix, Arizona  85016
Central Florida Health AllianceLeesburg, Florida  34748
Lewis Hall Singeltary Oncology CenterThomasville, Georgia  31792
Southern Illinois School of MedicineSpringfield, Illinois  62794
South Coast Health SystemFall River, Massachusetts  02720
North Mississippi Hematology & OncologyTupelo, Mississippi  38801