Trial record 1 of 2 for:    The 5-Year Prospective Cohort Study (Simplicity)
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Studying First Line Treatment of Chronic Myeloid Leukemia (CML) in a Real-world Setting (SIMPLICITY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Bristol-Myers Squibb
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01244750
First received: November 15, 2010
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to better understand the use of tyrosine kinase inhibitors (TKI) in patients newly diagnosed with CML and their quality of life in a real-world setting.


Condition
Chronic Myeloid Leukemia

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Studying Interventions for Managing Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase: The 5-Year Prospective Cohort Study (SIMPLICITY)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • The rate of Complete Cytogenetic Response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The duration of initial TKI treatment [ Time Frame: 5-years from study index date ] [ Designated as safety issue: No ]
    Initiation of first-line TKI, (whether Dasatinib, Imatinib, Nilotinib)

  • The rate of discontinuation and treatment changes after initial TKI treatment [ Time Frame: Every 6 months for a follow-up period of 5-years from study index date ] [ Designated as safety issue: No ]
    Dates of switches in therapy from initial TKI treatment, Reasons for treatment discontinuation (i.e. side effects, mutations, etc.), Subsequent lines of CML treatments (start and stop dates)

  • The rate of best response to therapy (i.e. hematologic, cytogenetic, molecular response) [ Time Frame: Every 6 months for a follow-up period of 5-years from study index date ] [ Designated as safety issue: No ]
    Results and dates of: all bone marrow aspirates, blood tests, cytogenetics, Polymerase Chain Reaction (PCR), Fluorescent In-Situ Hybridization (FISH), and Physical exam

  • The adherence to treatment [ Time Frame: Every 6 months for a follow-up period of 5-years from study index date ] [ Designated as safety issue: No ]
    Morisky Medication Adherence Scale - 8 Items is a validated self-reported measure of medication adherence.


Secondary Outcome Measures:
  • Impact of first-line treatment options on quality of life [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]

    Questionnaires used for assessment:

    Functional Assessment of Cancer Therapy - General (FACT-G), Cancer Therapy Satisfaction Questionnaire (CTSQ), MD Anderson Symptom Inventory - CML (MDASI-CML).


  • Non-hematologic side effects from treatment affecting patient quality of life and outcomes [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
    Treatment discontinuations and changes

  • Patient satisfaction with CML treatment [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
    Cancer Therapy Satisfaction Questionnaire (CTSQ)

  • Patterns of disease monitoring as observed in a real-world setting [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
    MD Anderson Symptom Inventory - CML (MDASI-CML) Questionnaire - disease-specific module of the MDASI7 which is a brief measure of severity and impact of cancer-related symptoms on daily function

  • Resource utilization associated with CML management [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
    To evaluate healthcare resource utilization, descriptive statistics will describe real-world disease monitoring patterns, frequency of testing, and resources used for disease management for each treatment cohort.


Estimated Enrollment: 1400
Study Start Date: October 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
First line TKI treatment: Imatinib
Diagnosed CML patients who receive first line TKI treatment: Imatinib
First line TKI treatment: Nilotinib
Diagnosed CML patients who receive first line TKI treatment: Nilotinib
First line TKI treatment: Dasatinib
Diagnosed CML patients who receive first line TKI treatment: Dasatinib
Imatinib treated patients
Imatinib treated patients if their study index date is between January 2, 2008 and September 30, 2010

Detailed Description:

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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients will be recruited at oncology practices or oncology centers linked to a hospital in the North Americas, Europe and potentially at additional sites in South America, and Asia

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01244750

Contacts
Contact: For participation information at a USA site use a phone number below. For Site information outside USA please email: clinical.trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial site that are recruiting have contact information at this time.

  Hide Study Locations
Locations
United States, Alabama
Northwest Alabama Cancer Center Recruiting
Muscle Shoals, Alabama, United States, 35661
Contact: James Daugherty, Site 020    256-381-1001      
United States, Arizona
Arizona Oncology Associates, PC - HAL Active, not recruiting
Phoenix, Arizona, United States, 85016
Arizona Oncology Associates, PC - NAHOA Recruiting
Sedona, Arizona, United States, 86336
Contact: Deborah Lindquist, Site 094    928-204-4163      
Arizona Oncology Associates, PC - HOPE Recruiting
Tucson, Arizona, United States, 85704
Contact: Donald Brooks, Site 084    520-797-4468      
United States, Arkansas
Genesis Cancer Center Recruiting
Hot Springs National Park, Arkansas, United States, 71913
Contact: Timothy Webb, Site 129    501-624-7700      
NEA Baptist Clinic Recruiting
Jonesboro, Arkansas, United States, 72401
Contact: Allen Nixon, Site 050    870-934-5343      
Little Rock Hematology Oncology Associates Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Kamal Patel, Site 042    501-219-8777      
United States, California
Pacific Cancer Medical Center, Inc Recruiting
Anaheim, California, United States, 92801
Contact: Ajit Maniam, Site 007    714-999-1465 ext 206      
Southwest Cancer Care Medical Group Recruiting
Escondido, California, United States, 92025
Contact: Michael Kosmo, Site 044    760-737-2666      
Wilshire Oncology Medical Group, Inc Recruiting
Glendora, California, United States, 91741
Contact: Gargi Upadhyaya, Site 088    626-335-0213      
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Sikander Ailawadhi, Site 026    323-865-3950      
St. Joseph's Hospital Active, not recruiting
Orange, California, United States, 92868
PMK Medical Group, Inc. DBA Ventura Recruiting
Oxnard, California, United States, 93030
Contact: Rosemary McIntyre, Site 097    805-485-8709      
Stockton Hematology Oncology Active, not recruiting
Stockton, California, United States, 95204
Tahoe Forest Health System Cancer Center Active, not recruiting
Truckee, California, United States, 96160
United States, Colorado
Rocky Mountain Cancer Centers Recruiting
Boulder, Colorado, United States, 80303
Contact: David Andorsky, Site 086    303-385-2071      
United States, Connecticut
Medical Oncology and Blood Disorders, LLP Recruiting
Manchester, Connecticut, United States, 06040
Contact: Michael Reale, Site 034    860-646-2518      
Stamford Hospital Active, not recruiting
Stamford, Connecticut, United States, 06904
United States, District of Columbia
George Washington University Active, not recruiting
Washington, District of Columbia, United States, 20237
Washington Hospital Center, Washington Cancer Institute Active, not recruiting
Washington D.C, District of Columbia, United States, 20010
United States, Florida
Hematology And Medical Oncology Of Southern Palm Beach County Recruiting
Boynton Beach, Florida, United States, 33435
Contact: Roger Brito, Site 030    561-742-0065      
Broward Oncology Associates Active, not recruiting
Fort Lauderdale, Florida, United States, 33308
Palm Springs Research Institute Recruiting
Hialeah, Florida, United States, 33012
Contact: Eduardo Gomez, Site 075    305-827-3335      
Baptist Cancer Institute Recruiting
Jacksonville, Florida, United States, 32207
Contact: Troy Guthrie, Site 015    904-339-1260      
University Of Florida Recruiting
Jacksonville, Florida, United States, 32209
Contact: Rana Fauzia, Site 0184    904-244-1103      
Watson Clinic Recruiting
Lakeland, Florida, United States, 33805
Contact: Fred Schreiber, Site 140    863-687-1322      
Central Florida Health Alliance Active, not recruiting
Leesburg, Florida, United States, 34748
Baptist Cancer Center Active, not recruiting
Miami, Florida, United States
Florida Cancer Specialists Recruiting
New Port Richey, Florida, United States, 34655
Contact: Gayle Wright, Site 032    727-842-8411      
Cancer Centers of Florida Recruiting
Orlando, Florida, United States, 32806
Contact: Alberto Mizrachi, Site 105    407-426-8484      
Lake County Oncology and Hematology Recruiting
Tavares, Florida, United States, 32778
Contact: Maen Hussein, Site 062    352-343-1117      
Space Coast Cancer Center Recruiting
Titusville, Florida, United States, 32796
Contact: Firas Muwalla, Site 002    321-268-4200      
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Hanah Khoury, Site 118    404-778-4907      
Peachtree Hematology-Oncology Active, not recruiting
Atlanta, Georgia, United States, 30318
Northwest Georgia Oncology Centers, PC Recruiting
Marietta, Georgia, United States, 30060
Contact: Robert Hermann, Site 017    770-281-5124      
Georgia Cancer Specialist Recruiting
Sandy Springs, Georgia, United States, 30342
Contact: Mansoor Saleh, Site 028    404-256-4777      
Lewis Hall Singeltary Oncology Center Active, not recruiting
Thomasville, Georgia, United States, 31792
United States, Hawaii
OnCare Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jon Fukumoto, Site 064    808-524-6115      
Kaiser Permanente Honolulu Active, not recruiting
Honolulu, Hawaii, United States, 96819
Straub Clinical & Hospital Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Ian Okazaki, Site 134    808-522-4333      
United States, Illinois
Mahafzah Medical Center Recruiting
Evergreen Park, Illinois, United States, 60805
Contact: Mahmoud Mahafzah, Site 058    281-517-0550      
Delnor Community Hospital Active, not recruiting
Geneva, Illinois, United States, 60134
Orchard Health Care Research Recruiting
Niles, Illinois, United States, 60076
Contact: Ira Oliff, Site 001    773-947-4315      
Mid-Illinois Hem/Onc Asoc Recruiting
Normal, Illinois, United States, 61761
Contact: John Migas, Site 137    309-452-9701      
North Chicago VA Medical Center Recruiting
North Chicago, Illinois, United States, 60064
Contact: Rami Haddad, Site 047    847-688-1900      
Southern Illinois School of Medicine Recruiting
Springfield, Illinois, United States, 62794
Contact: Aziz Khan, Site 0171    217-545-5817      
Carle Cancer Center Active, not recruiting
Urbana, Illinois, United States, 61801
Central DuPage Hospital Active, not recruiting
Winfield, Illinois, United States, 60190
United States, Indiana
Saint John's Cancer Center Recruiting
Anderson, Indiana, United States, 46016
Contact: Robert Ash, Site 009    765-646-8509      
Indiana Blood and Marrow Transplantation Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Luke Akard, Site 005    317-865-5500      
Investigative Clinical Research of Indiana Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Robert Manges, Site 110    317-297-2208      
Horizon Oncology Research, Inc Active, not recruiting
Lafayette, Indiana, United States, 47905
Cancer Care Center, Inc. PC Recruiting
New Albany, Indiana, United States, 47150
Contact: Naveed Chowhan, Site 063    812-945-4000      
United States, Iowa
N. Iowa Mercy Cancer Center Recruiting
Mason City, Iowa, United States, 50401
Contact: Steven Snyder, Site 012    641-422-6320      
United States, Kansas
Hutchinson Clinic Recruiting
Hutchinson, Kansas, United States, 67502
Contact: Fadi Estephan, Site 072    620-669-2500      
Cotton O'Neil Cancer Center Recruiting
Topeka, Kansas, United States, 66606
Contact: Karissa Boyd, Site 059    785-270-4935      
Cancer Center of Kansas Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker Dakhil, Site 024    316-262-4467      
United States, Kentucky
Central Baptist Hospital Recruiting
Lexington, Kentucky, United States, 40503
Contact: Lee Hicks, Site 052    859-260-6456      
University of Louisville Hospital - Brown Cancer Center Active, not recruiting
Louisville, Kentucky, United States, 40202
Consultants In Blood Disorders Active, not recruiting
St Matthews, Kentucky, United States, 40207
United States, Louisiana
Ochsner Clinic Foundation Active, not recruiting
New Orleans, Louisiana, United States, 70121
Willis-Knighton Cancer System Recruiting
Shreveport, Louisiana, United States, 71103
Contact: Michael Moore, Site 066    318-212-8671      
United States, Maryland
Maryland Oncology Hematology Pa Recruiting
Columbia, Maryland, United States, 21044
Contact: Edward Lee, Site 023    410-964-2212      
Frederick Memorial Hospital Active, not recruiting
Frederick, Maryland, United States, 21701
United States, Massachusetts
Sturdy Hematology & Oncology Associates Active, not recruiting
Attleboro, Massachusetts, United States, 02703
Boston VA Healthcare System Recruiting
Boston, Massachusetts, United States, 02130
Contact: Valia Boosalis, Site 065    857-364-5033      
South Coast Health System Active, not recruiting
Fall River, Massachusetts, United States, 02720
Commonwealth Hematology-Oncology, P.C. Recruiting
Quincy, Massachusetts, United States, 02169
Contact: Darren Evanchuk, Site 049    617-479-3550      
UMass Medical Center Active, not recruiting
Worcester, Massachusetts, United States, 01655
United States, Michigan
Cancer & Hematology Centers of Western Michigan Active, not recruiting
Grand Rapids, Michigan, United States, 49503
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Raymond Lord, Site 036    269-373-7458      
Michigan State University Recruiting
Lansing, Michigan, United States, 48910
Contact: Anas Al-Janadi, Site 115    517-975-9547      
United States, Mississippi
North Mississippi Hematology & Oncology Active, not recruiting
Tupelo, Mississippi, United States, 38801
United States, Missouri
St John's Clinic for Cancer and Hematology Recruiting
Springfield, Missouri, United States, 65807
Contact: Viran Holden, Site 051    417-820-8099      
United States, Montana
Billings Clinic Recruiting
Billings, Montana, United States, 59101
Contact: Brock Whittenberger, Site 048    406-435-7397      
United States, Nebraska
Omaha VAMC Recruiting
Omaha, Nebraska, United States, 68105
Contact: Apar Ganti, Site 073    402-995-4121      
United States, New Hampshire
Portsmouth Regional Hospital Recruiting
Portsmouth, New Hampshire, United States, 03801
Contact: Paul Poulin, Site 114    603-433-4951      
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Stuart Goldberg, Site 016    201-996-5900      
Hematology-Oncology Associates of Northern NJ, PA Recruiting
Morristown, New Jersey, United States, 07962
Contact: Charles Farber, Site 099    973-538-5210      
Southern Oncology Hematology Recruiting
Vineland, New Jersey, United States, 08360
Contact: Kush Sachdeva, Site 046    856-696-9550      
United States, New York
Montefiore Medical Center / AECOM Recruiting
Bronx, New York, United States, 10467
Contact: Stefan Barta, Site 136    718-920-3145      
Broome Oncology Recruiting
Johnson City, New York, United States, 13790
Contact: Ronald Harris, Site 091    607-763-6310      
Advanced Oncology Recruiting
New York, New York, United States, 10013
Contact: Kin Lam, Site 107    212-941-9020      
St. Lukes Roosevelt Medical Center Recruiting
New York, New York, United States, 10019
Contact: Peter Wiernik, Site 131    212-636-3338      
Vassar Brothers Medical Center Active, not recruiting
Poughkeepsie, New York, United States, 12601
Stony Brook University Hospital Recruiting
Stony Brook, New York, United States, 11794
Contact: Michael Schuster, Site 061    631-444-3577      
United States, North Carolina
Alamance Regional Cancer Center Active, not recruiting
Burlington, North Carolina, United States, 27215
Waverly Hematology Oncology Recruiting
Cary, North Carolina, United States, 27518
Contact: Suzanne Kirby, Site 019    919-233-8585      
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: David Rizzieri, Site 035    919-668-1040      
Gaston Hematology Oncology Recruiting
Gastonia, North Carolina, United States, 28054
Contact: Keith Ayrons, Site 013    704-865-5210      
East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Contact: Adam Asch, Site 130    252-744-0282      
United States, Ohio
Akron General Medical Center Recruiting
Akron, Ohio, United States, 44302
Contact: John Petrus, Site 014    330-344-6505      
Gabrail Cancer Center Active, not recruiting
Canton, Ohio, United States, 44718
Signal Point Clinical Research Center, LLC Recruiting
Middletown, Ohio, United States, 45042
Contact: Nandagopal Vrindavanam, Site 126    513-423-0504      
Medical Center of Newark Recruiting
Newark, Ohio, United States, 43055
Contact: Leslie Laufman, Site 053    614-563-8462      
United States, Oklahoma
Cancer Care Associates Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Charles Strnad, Site 033    918-292-2000      
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Michael Mauro, Site 079    503-494-0376      
Hematology/Oncology Salem LLP Recruiting
Salem, Oregon, United States, 97301
Contact: John Strother, Site 132    503-561-6444      
United States, Pennsylvania
Lehigh Valley Hospital Active, not recruiting
Allentown, Pennsylvania, United States, 18103
St. Luke's Hospital and Health Network Active, not recruiting
Bethlehem, Pennsylvania, United States, 18015
Medical Oncology Associates of Wyoming Valley, PC Recruiting
Kingston, Pennsylvania, United States, 18704
Contact: Bruce Saidman, Site 101    570-288-7231      
Lancaster General Health Recruiting
Lancaster, Pennsylvania, United States, 17601
Contact: Nandi Reddy, Site 123    717-544-3600      
Veterans Research Foundation of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Vida Passero, Site 043    412-360-6178      
Berks Hematology-Oncology Active, not recruiting
West Reading, Pennsylvania, United States, 19611
Geisinger Health System Recruiting
Wilkes Barre, Pennsylvania, United States, 18711
Contact: James Brady, Site 057    570-819-5859      
Cancer Care Association Of York Recruiting
York, Pennsylvania, United States, 17403
Contact: Amir Tabatabai, Site 139    717-741-9229      
United States, Rhode Island
Hematology and Oncology Associates of RI Recruiting
Cranston, Rhode Island, United States, 02920
Contact: Sundaresan Sambandam, Site 112    401-943-4660      
The Cancer Center at Memorial Hospital Active, not recruiting
Pawtucket, Rhode Island, United States, 02860
United States, South Carolina
Charleston Cancer Center Recruiting
Charleston, South Carolina, United States, 29406
Contact: Charles Holladay, Site 135    843-576-1024      
United States, South Dakota
Avera Research Institute Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Ahmed Galal, Site 0229    605-322-3025      
Prairie Lakes Healthcare System, Inc Recruiting
Watertown, South Dakota, United States, 57201
Contact: Bipinkumar Amin, Site 029    605-882-6800      
United States, Tennessee
Thompson Cancer Survival Center Withdrawn
Knoxville, Tennessee, United States, 37916
Tennessee Cancer Specialists Recruiting
Knoxville, Tennessee, United States, 37909
Contact: Tracy Dobbs, MD, Site 004    865-934-2672      
University of Tennessee Medical Center Active, not recruiting
Knoxville, Tennessee, United States, 37920
Integrity Oncology Withdrawn
Memphis, Tennessee, United States, 38120
United States, Texas
Texas Oncology Recruiting
Amarillo, Texas, United States, 79106
Contact: Leonardo Forero, Site 090    806-358-8654      
Texas Oncology - Arlington South Recruiting
Arlington, Texas, United States, 76014
Contact: Scott Fleischauer, Site 089    817-467-6092      
Texas Oncology-Austin North Recruiting
Austin, Texas, United States, 78758
Contact: Kevin Doner, Site 092    513-873-8900      
Julie & Ben Rogers Cancer Institute Recruiting
Beaumont, Texas, United States, 77701
Contact: S. T. Ramachandran, Site 027    409-659-2542      
Texas Oncology-Dallas Presbyterian Hospital Recruiting
Dallas, Texas, United States, 75231
Contact: Kristi McIntyre, Site 096    214-739-4175      
Texas Oncology-Methodist Charlton Cancer Center Recruiting
Dallas, Texas, United States, 75237
Contact: John Cox, Site 087    972-709-2580      
Texas Oncology-Medical City Dallas Recruiting
Dallas, Texas, United States, 75230-2510
Contact: Michael Savin, Site 102    972-566-4268      
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jorge Cortes, Site 025    713-794-5783      
Michael DeBakey VA Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Sarvari Yellapragada, Site 054    713-794-7303      
Texas Oncology Recruiting
Lewisville, Texas, United States, 75067
Contact: Derrick Nguyen, Site 098    972-459-1300      
Texas Oncology-McAllen South Second Recruiting
McAllen, Texas, United States, 78503
Contact: Billie Marek, Site 095    956-687-5150      
Texas Oncology Recruiting
Mesquite, Texas, United States, 75150
Contact: Sreenivas Chittoor, Site 085    972-686-6411      
Texas Oncology-Midland Allison Cancer Center Recruiting
Midland, Texas, United States, 79701
Contact: David Watkins, Site 103    432-687-1949      
Texas Oncology-Odessa West Texas Cancer Center Recruiting
Odessa, Texas, United States, 79761
Contact: Pankaj Khandelwal, Site 093    432-335-8275      
Texas Oncology Recruiting
Paris, Texas, United States, 75460-5004
Contact: Sucharu Prakash, Site 100    903-785-0031      
North Texas Regional Cancer Center Recruiting
Plano, Texas, United States, 75075
Contact: Robert Kirby, Site 121    972-867-3577      
Cancer Care Centers of South Texas Recruiting
San Antonio, Texas, United States, 78217
Contact: David Gordon, Site 104    210-656-7177      
Texas Oncology Recruiting
Waco, Texas, United States, 76712
Contact: Robert Anderson, Site 082    254-399-0741      
United States, Virginia
Cancer Outreach Associates Withdrawn
Abingdon, Virginia, United States, 24211
Danville Hematology & Oncology Active, not recruiting
Danville, Virginia, United States, 24541
Hematology Oncology Associates of Fredricksburg Recruiting
Fredericksburg, Virginia, United States, 22408
Contact: Christopher Vaughn, Site 010    540-371-0079      
Peninsula Cancer Institute Recruiting
Newport News, Virginia, United States, 23601
Contact: Guy Tillinghast, Site 076    757-534-5555      
Blue Ridge Cancer Care Recruiting
Roanoke, Virginia, United States, 24014
Contact: Lowell Inhorn, Site 008    540-982-0237      
United States, Washington
Swedish Cancer Institute-Eastside Hematology/Oncology Active, not recruiting
Bellevue, Washington, United States, 98005
Providence Cancer Center at Sacred Heart Medical Center Recruiting
Spokane, Washington, United States, 99208
Contact: Arvind Chaudhry, Site 119    509-462-2273      
Wenatchee Valley Medical Center Recruiting
Wenatchee, Washington, United States, 98801
Contact: Mitchell Garrison, Site 031    509-665-5800 ext 5014      
Yakima Valley Memorial Hospital/North Star Lodge Recruiting
Yakima, Washington, United States, 98902
Contact: Thomas Boyd, Site 083    509-574-3493      
United States, West Virginia
Charleston Area Medical Center Active, not recruiting
Charleston, West Virginia, United States, 25304
City Hospital - West Virginia University Hospital East Recruiting
Martinsburg, West Virginia, United States, 25401
Contact: Eric Bonnem, Site 116    304-267-1944      
Wheeling Hospital Recruiting
Wheeling, West Virginia, United States, 26003
Contact: Manish Monga, Site 011    304-243-6442      
United States, Wisconsin
Aspirus Regional Cancer Center Recruiting
Wausau, Wisconsin, United States, 53792
Contact: Harish Ahuja, Site 037    715-847-2866      
France
Local Institution Active, not recruiting
Blois cedex, France, 41016
Local Institution Active, not recruiting
Bordeaux, France, 33300
Local Institution Active, not recruiting
Chalon/Saone cedex, France, 71100
Local Institution Active, not recruiting
Chambéry, France, 73011
Local Institution Active, not recruiting
Le Mans Cedex 09, France, 72037
Local Institution Recruiting
Pierre Benite, France, 69495
Contact: , Site 170         
Local Institution Active, not recruiting
PRINGY cedex, France, 74374
Germany
Local Institution Recruiting
Amberg, Germany, 92224
Contact: , Site 077         
Local Institution Recruiting
Aschaffenburg, Germany
Contact: , Site 045         
Local Institution Recruiting
Baden-Baden, Germany
Contact: , Site 041         
Local Institution Recruiting
Bamberg, Germany, 96049
Contact: Site 0200         
Local Institution Active, not recruiting
Berlin, Germany, 13353
Local Institution Active, not recruiting
Berlin, Germany, 12203
Local Institution Active, not recruiting
Bonn, Germany, 53105
Local Institution Recruiting
Bottrop, Germany, 46236
Contact: , Site 069         
Local Institution Active, not recruiting
Coburg, Germany, 96450
Local Institution Active, not recruiting
Darmstadt, Germany, 64283
Local Institution Recruiting
Essen, Germany, 45136
Contact: Site 0221         
Local Institution Recruiting
Frankfurt am Main, Germany
Contact: , Site 039         
Local Institution Recruiting
Frankurt am Main, Germany, 60389
Contact: Site 0202         
Local Institution Active, not recruiting
Greifswald, Germany, 17475
Local Institution Recruiting
Hamm, Germany, 59063
Contact: Site 0189         
Local Institution Recruiting
Hof, Germany, 95028
Contact: Site 0198         
Local Institution Recruiting
Idar-Oberstein, Germany, 55743
Contact: Site 0212         
Local Institution Active, not recruiting
Kaiserslautern, Germany
Local Institution Active, not recruiting
Kassel, Germany, 34117
Local Institution Recruiting
Koblenz, Germany, 56068
Contact: , Site 070         
Local Institution Active, not recruiting
Köln, Germany, 50677
Local Institution Recruiting
Köln, Germany, 50674
Contact: Site 0174         
Local Institution Recruiting
Landshut, Germany, 84028
Contact: Site 0207         
Local Institution Active, not recruiting
Lebach, Germany, 66822
Local Institution Active, not recruiting
Leipzig, Germany, 04103
Local Institution Recruiting
Mülheim a. d. Ruhr, Germany, 45468
Contact: , Site 067         
Local Institution Recruiting
Offenbach, Germany
Contact: , Site 040         
Local Institution Recruiting
Potsdam, Germany, 14467
Contact: Site 0185         
Local Institution Recruiting
Rostock, Germany, 18057
Contact: , Site 133         
Local Institution Recruiting
Rötha, Germany, 04571
Contact: , Site 071         
Local Institution Recruiting
Singen, Germany, 78224
Contact: Site 0178         
Local Institution Recruiting
Soest, Germany, 59494
Contact: Site 0215         
Local Institution Recruiting
Ulm, Germany, 89081
Contact: Site 0192         
Local Institution Active, not recruiting
Velbert, Germany, 42551
Local Institution Recruiting
Weiden, Germany, 92637
Contact: , Site 081         
Local Institution Active, not recruiting
Würzburg, Germany, 97080
Italy
Local Institution Recruiting
Bari, Italy, 70124
Contact: Site 0206         
Local Institution Active, not recruiting
Brescia, Italy, 25123
Local Institution Recruiting
Brindisi, Italy, 72100
Contact: Site 0235         
Local Institution Recruiting
Catania, Italy, 95124
Contact: Site 0182         
Local Institution Recruiting
Florence, Italy, 50134
Contact: Site 0164         
Local Institution Recruiting
Milan, Italy, 20122
Contact: , Site 145         
Local Institution Recruiting
Milano, Italy, 20162
Contact: , Site 078         
Local Institution Active, not recruiting
Modena, Italy, 44100
Local Institution Active, not recruiting
Monza, Italy, 20052
Local Institution Recruiting
Pavia, Italy, 27100
Contact: Site 0197         
Local Institution Active, not recruiting
Perugia, Italy, 06156
Local Institution Recruiting
Pesaro, Italy, 61122
Contact: Site 0153         
Local Institution Recruiting
Rionero in Vulture, Italy, 85028
Contact: Site 0179         
Local Institution Recruiting
Roma, Italy, 00189
Contact: Site 0214         
Local Institution Recruiting
Rome, Italy, 00168
Contact: Site 0167         
Local Institution Recruiting
Rome, Italy, 00161
Contact: Site 0187         
Local Institution Recruiting
Siena, Italy, 53100
Contact: Site 0220         
Local Institution Recruiting
Terni, Italy, 05100
Contact: Site 0166         
Local Institution Recruiting
Udine, Italy, 33100
Contact: Site 0208         
Netherlands
Local Institution Recruiting
Hoofddorp, Netherlands, 2134 TM
Contact: , Site 056         
Puerto Rico
Puerto Rico Hematology Oncology Group Recruiting
Bayamon, Puerto Rico, 00961
Contact: Yelitza Ruiz, Site 124    787-786-8088      
Russian Federation
Local Institution Recruiting
Saint-Petersburg, Russian Federation, 197022
Contact: , Site 125         
Spain
Local Institution Active, not recruiting
La Coruña, Spain, 15006
Local Institution Active, not recruiting
Oviedo - Asturias, Spain, 33006
Local Institution Active, not recruiting
Pamplona, Spain, 31008
Local Institution Active, not recruiting
Salamanca, Spain, 37007
Local Institution Recruiting
Santiago de Compostela-A Coruña, Spain, 15706
Contact: , Site 122         
Local Insitution Recruiting
Toledo, Spain, 45004
Contact: Site 0172         
Sponsors and Collaborators
Bristol-Myers Squibb
ICON Clinical Research
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01244750     History of Changes
Other Study ID Numbers: CA180-330
Study First Received: November 15, 2010
Last Updated: September 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Bristol-Myers Squibb:
Chronic Phase - Chronic Myeloid Leukemia

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on September 29, 2014