Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00123474
First received: July 21, 2005
Last updated: July 29, 2015
Last verified: July 2015
  Purpose

This is a phase III study of BMS-354825 in subjects with chronic phase Philadelphia chromosome or BCR-ABL positive chronic myelogenous leukemia, who are resistant or intolerant to imatinib mesylate (Gleevec).


Condition Intervention Phase
Myeloid Leukemia, Chronic, Chronic-Phase
Drug: dasatinib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Two-by-Two, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 50 mg or 70 mg Twice Daily or 100 mg or 140 mg Once Daily in Subjects With Chronic Phase Philadelphia Chromosome or BCR-ABL Positive Chronic Myelogenous Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Percent of Participants With Major Cytogenetic Response (MCyR) After at Least 6 Months Follow-Up [ Time Frame: Baseline and after at least 6 months follow-up ] [ Designated as safety issue: No ]
    Cytogenetic response (CyR) was based on the number of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a Bone Marrow (BM) sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): >0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: >35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: >65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: >95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). Baseline=closest to, but no later than, the first day of study drug for treated participants and closest to, but no later than, the date of randomization, for those who were randomized but who never received treatment, unless otherwise specified.


Secondary Outcome Measures:
  • Percent of Participants With MCyR At or Prior to 24 Months Follow-Up [ Time Frame: Baseline and after at least 24 months follow-up ] [ Designated as safety issue: No ]
    CyR was based on the number of Ph+ metaphases among cells in metaphase on a Bone Marrow (BM) sample. The criteria for CyR were as follows: CCyR: 0% Ph+ cells in metaphase in BM; PCyR: >0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: >35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: >65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: >95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of CCyR or PCyR. Baseline=closest to, but no later than, the first day of study drug for treated participants and closest to, but no later than, the date of randomization, for those who were randomized but who never received treatment, unless otherwise specified.

  • Percent of Participants With Complete Hematologic Response (CHR) After at Least 6 and 24 Months Follow-Up [ Time Frame: Baseline and after at least 6 and 24 months follow-up ] [ Designated as safety issue: No ]
    A complete hematologic response (CHR) was obtained when all the following criteria were met: White Blood Cells (WBC) ≤ institutional upper limit of normal (ULN); Platelets < 450,000/mm³; No blasts or promyelocytes in peripheral blood (PB); < 5% myelocytes plus metamyelocytes in PB; Basophils in PB < 20%; No extramedullary involvement (including no splenomegaly or hepatomegaly). Hematologic responses were counted anytime following 14 days after the dosing start date.

  • Time to MCyR in Participants With MCyR After At Least 6 Months Follow-Up [ Time Frame: Baseline and after at least 6 months follow-up ] [ Designated as safety issue: No ]
    Time to MCyR was defined as the time from the first dosing date until criteria were first met for CCyR or PCyR, whichever occurred first. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to MCyR response for responders and time to last cytogenetic assessment for non-responders).

  • Time to CHR in Participants With CHR After at Least 6 Months Follow-Up [ Time Frame: Baseline and after at least 6 months follow-up ] [ Designated as safety issue: No ]
    Time to CHR was defined as the time from the first dosing date until criteria are first met for the response. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to CHR response for responders and time to last hematologic assessment for non-responders).

  • Time to MCyR in Participants With MCyR After at Least 24 Months Follow-Up [ Time Frame: Baseline and after at least 24 months follow-up ] [ Designated as safety issue: No ]
    Time to MCyR was defined as the time from the first dosing date until criteria were first met for CCyR or PCyR, whichever occurred first. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to MCyR response for responders and time to last cytogenetic assessment for non-responders). Cytogenetic assessments were not done after the 2 Year Follow-up.

  • Time to CHR in Participants With CHR After at Least 24 Months Follow-Up [ Time Frame: Baseline and after at least 24 months follow-up ] [ Designated as safety issue: No ]
    Time to CHR was defined as the time from the first dosing date until criteria are first met for the response. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to CHR response for responders and time to last hematologic assessment for non-responders). Cytogenetic assessments were not done after the 2 Year Follow-up.

  • Number of Participants With MCyR Whose Disease Progressed [ Time Frame: Baseline and after at least 24 months follow-up ] [ Designated as safety issue: No ]
    Progression in a participant=participant achieved a CHR and no longer met the criteria consistently over consecutive 2-weeks after starting their maximum dose; had no CHR after receiving their maximum dose and had an increase in white blood count (WBC) defined as a doubling of the count from the lowest value to >20,000/mm^3 or an increase by > 50,000/mm^3 on two assessments performed at least 2 weeks apart; participant met criteria of accelerated or blast phase CML at any time; had a MCyR and subsequently no longer met the criteria for MCyR after starting their maximum dose; had a ≥ 30% absolute increase in the number of Ph+ metaphases. Although a related secondary endpoint was estimated duration of MCyR, medium duration of MCyR could not be estimated because the majority of participants with MCyR continued to respond, or could not be reliably estimated because of the large number of censored participants. Cytogenetic assessments were not done after the 24 month follow-up.

  • Number of Participants With CHR Whose Disease Progressed [ Time Frame: Baseline and after at least 24 months follow-up ] [ Designated as safety issue: No ]
    Progression in a participant=achieved a CHR and subsequently no longer met the criteria consistently over a consecutive 2-week period after starting their maximum dose; had no CHR after receiving their maximum dose and had an increase in white blood count (WBC) defined as a doubling of the count from the lowest value to >20,000/mm^3 or an increase by > 50,000/mm^3 on two assessments performed at least 2 weeks apart; met the criteria of accelerated or blast phase CML at any time; had a MCyR and subsequently no longer met the criteria for MCyR after starting their maximum dose; had a ≥ 30% absolute increase in the number of Ph+ metaphases. Although a related secondary endpoint was estimated duration of CHR, medium duration of CHR could not be estimated because the majority of participants with CHR continued to respond, or could not be reliably estimated because of the large number of censored participants.

  • Number of Participants With MCyR and Baseline BCR-ABL Gene Mutation - All Treated Participants [ Time Frame: Baseline to Year 2 ] [ Designated as safety issue: No ]
    BCR-ABL mutations were assessed in participants prior to the start of study drug (baseline) and at the time of disease progression or at end of therapy. Quantification of BCR-ABL transcripts in peripheral blood was evaluated using quantitative reverse transcriptase polymerase chain reaction (Q-RT-PCR, RT-PCR).

  • Percent of Imatinib-Resistant Participants With Progression Free Survival (PFS) After at Least 24, 36, 48, 60, 72, and 84 Months Follow-Up [ Time Frame: Baseline and after 84 months follow-up ] [ Designated as safety issue: No ]
    PFS= time from randomization until: CHR achieved and participant subsequently no longer met criteria for CHR over 2 weeks; no CHR after receiving maximum dose and an increase in WBC (ie, doubling of the count from the lowest value to > 20,000/mm^3 or an increase by > 50,000/mm^3 on 2 assessments performed 2 weeks apart); participant met criteria of accelerated phase or blast phase CML; participant had MCyR and subsequently no longer met criteria for MCyR after starting maximum dose; participant had a ≥ 30% absolute increase in number of Ph+ metaphases. Deaths without a reported prior progression were considered to have progressed on the date of death; those who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. When first progression reported during follow-up, it was censored at last on-study assessment. If the first progression reported during follow-up was death, participant considered to have progressed at date of death.

  • Percent of Imatinib-Resistant Participants With Overall Survival (OS) After at Least 24, 36, 48, 60, 72, and 84 Months Follow-Up [ Time Frame: Baseline and after 84 months follow-up ] [ Designated as safety issue: No ]
    Overall survival (OS) was defined as the time from randomization until death. Survival data were collected for up to 5 years on participants who had discontinued dasatinib treatment. Participants who did not die or who were lost to follow-up were censored on the last date the participant was known to be alive.

  • Percent of Participants Intolerant to Imatinib With MCyR After at Least 6 Months and After at Least 24 Months Follow-Up, by QD and BID Schedules and by Total Daily Dose [ Time Frame: Baseline and after at Least 6 Months and 24 Months Follow-Up ] [ Designated as safety issue: No ]
    CyR was based on the number of Ph+ metaphases among cells in metaphase on a BM sample. The criteria for CyR were as follows: complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; PCyR: >0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: >35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: >65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: >95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of CCyR or PCyR.

  • Percent of Participants Intolerant to Imatinib With CHR After at Least 6 Months and After at Least 24 Months Follow-Up [ Time Frame: Baseline and after at Least 6 Months and 24 Months Follow Up ] [ Designated as safety issue: No ]
    A CHR was obtained when all the following criteria were met: White Blood Cells (WBC) ≤ institutional upper limit of normal (ULN); Platelets < 450,000/mm³; No blasts or promyelocytes in peripheral blood (PB); < 5% myelocytes plus metamyelocytes in PB; Basophils in PB < 20%; No extramedullary involvement (including no splenomegaly or hepatomegaly). Hematologic responses were counted anytime following 14 days after the dosing start date.

  • Percent of Imatinib Intolerant Participants With Progression Free Survival After 24, 36, 48, 60, 72, and 84 Months of Follow-Up [ Time Frame: Baseline and after 84 months follow-up ] [ Designated as safety issue: No ]
    PFS= time from randomization until: CHR achieved and participant subsequently no longer met criteria for CHR over 2 weeks; no CHR after receiving maximum dose and an increase in WBC (ie, doubling of the count from the lowest value to > 20,000/mm^3 or an increase by > 50,000/mm^3 on 2 assessments performed 2 weeks apart); participant met criteria of accelerated phase or blast phase CML; participant had MCyR and subsequently no longer met criteria for MCyR after starting maximum dose; participant had a ≥ 30% absolute increase in number of Ph+ metaphases. Deaths without a reported prior progression were considered to have progressed on the date of death; those who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. When first progression reported during follow-up, it was censored at last on-study assessment. If the first progression reported during follow-up was death, participant considered to have progressed at date of death.

  • Percent of Imatinib Intolerant Participants With Overall Survival After 24, 36, 48, 60, 72, and 84 Months of Follow-up [ Time Frame: Baseline and after 84 months follow-up ] [ Designated as safety issue: No ]
    Overall survival (OS) was defined as the time from randomization until death. Survival data were collected for up to 5 years on participants who had discontinued dasatinib treatment. Participants who did not die or who were lost to follow-up were censored on the last date the participant was known to be alive.

  • Percent of All Randomized Participants With Cytogenic and Hematologic Response by Dosing Schedule (QD or BID) and by Total Daily Dose (100 mg or 140 mg) After at Least 6 Months Follow-Up [ Time Frame: Baseline and after at least 6 months follow-up ] [ Designated as safety issue: No ]
    Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM. Partial cytogenetic response (PCyR): >0 to 35% Ph+ cells in metaphase in BM. MCyR: best cytogenetic response of CCyR or PCyR. A complete hematologic response (CHR) was obtained when all the following criteria were met: White Blood Cells (WBC) ≤ institutional upper limit of normal (ULN); Platelets < 450,000/mm³; No blasts or promyelocytes in peripheral blood (PB); < 5% myelocytes plus metamyelocytes in PB; Basophils in PB < 20%; No extramedullary involvement (including no splenomegaly or hepatomegaly). Hematologic responses were counted anytime following 14 days after the dosing start date.

  • Percent of All Randomized Participants With Cytogenic and Hematologic Response by Dosing Schedule (QD or BID) and by Total Daily Dose (100 mg or 140 mg) After at Least 24 Months Follow-Up [ Time Frame: Baseline and after at least 24 months follow-up ] [ Designated as safety issue: No ]
    Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM. Partial cytogenetic response (PCyR): >0 to 35% Ph+ cells in metaphase in BM. MCyR: best cytogenetic response of CCyR or PCyR. A complete hematologic response (CHR) was obtained when all the following criteria were met: White Blood Cells (WBC) ≤ institutional upper limit of normal (ULN); Platelets < 450,000/mm³; No blasts or promyelocytes in peripheral blood (PB); < 5% myelocytes plus metamyelocytes in PB; Basophils in PB < 20%; No extramedullary involvement (including no splenomegaly or hepatomegaly). Hematologic responses were counted anytime following 14 days after the dosing start date. No cytogenic assessments were made after 2 years of follow-up.

  • Percent of Participants With Progression Free Survival (PFS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up by Dose Schedule and Total Daily Dose - All Randomized Participants [ Time Frame: Baseline and after 84 Months Follow-up ] [ Designated as safety issue: No ]
    PFS= time from randomization until: CHR achieved and participant subsequently no longer met criteria for CHR over 2 weeks; no CHR after receiving maximum dose and an increase in WBC (ie, doubling of the count from the lowest value to > 20,000/mm^3 or an increase by > 50,000/mm^3 on 2 assessments performed 2 weeks apart); participant met criteria of accelerated phase or blast phase CML; participant had MCyR and subsequently no longer met criteria for MCyR after starting maximum dose; participant had a ≥ 30% absolute increase in number of Ph+ metaphases. Deaths without a reported prior progression were considered to have progressed on the date of death; those who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. When first progression reported during follow-up, it was censored at last on-study assessment. If the first progression reported during follow-up was death, participant considered to have progressed at date of death.

  • Percent of Participants Overall Survival at 24, 36, 48, 60, 72, and 84 Months Follow-Up - All Randomized Participants [ Time Frame: Baseline up to 84 Months Follow-up ] [ Designated as safety issue: No ]
    Overall survival (OS) was defined as the time from randomization until death. Survival data were collected for up to 5 years on participants who had discontinued dasatinib treatment. Participants who did not die or who were lost to follow-up were censored on the last date the participant was known to be alive.

  • Baseline and After 2 Years Follow-Up: Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led to Treatment Discontinuation [ Time Frame: Baseline and after 2 Years Follow-Up ] [ Designated as safety issue: Yes ]
    AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Baseline=closest to, but no later than, the first day of study drug for treated participants.

  • Baseline and After 7 Years Follow-Up and Study Closure: Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led toTreatment Discontinuation [ Time Frame: Baseline to 30 days post last dose;7 years follow up; study closure July 2014 ] [ Designated as safety issue: Yes ]
    AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Baseline=closest to, but no later than, the first day of study drug for treated participants. After the 2-year analysis and Protocol Amendment 02, those on a BID dosing schedule were allowed to switch to a QD dosing schedule. Due to the large number of participants switching from BID dosing to QD dosing, the abbreviated dosing data collection method incorporated in Amendment 03, the overall safety data are presented for the 100 mg QD group and combined for the other treatment groups.


Enrollment: 724
Study Start Date: July 2005
Study Completion Date: July 2014
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: dasatinib
Tablets, Oral, 50 mg BID, indefinitely, survival study
Other Names:
  • Sprycel
  • BMS-354825
Experimental: 2 Drug: dasatinib
Tablets, Oral, 70 mg BID, indefinitely, survival study
Other Names:
  • Sprycel
  • BMS-354825
Experimental: 3 Drug: dasatinib
Tablets, Oral, 100 mg QD, indefinitely, survival study
Other Names:
  • Sprycel
  • BMS-354825
Experimental: 4 Drug: dasatinib
Tablets, Oral, 140 mg QD, indefinitely, survival study
Other Names:
  • Sprycel
  • BMS-354825

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Inclusion Criteria:

  • Subjects with Philadelphia chromosome positive (Ph+) (or BCR/ABL+) chronic phase chronic myeloid leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.
  • Men and women, 18 years or older
  • Adequate hepatic function
  • Adequate renal function
  • Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Subjects who are eligible and willing to undergo transplantation during the screening period
  • A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
  • Uncontrolled or significant cardiovascular disease
  • Medications that increase bleeding risk
  • Medications that change heart rhythms
  • Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
  • History of significant bleeding disorder unrelated to CML
  • Concurrent incurable malignancy other than CML
  • Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study
  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: NCT00123474

  Hide Study Locations
Locations
United States, Alabama
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Central Hematology Oncology Medical Group Inc.
Alhambra, California, United States, 91801
Pacific Cancer Medical Center Inc
Anaheim, California, United States, 92801
Loma Linda University Cancer Center
Loma Linda, California, United States, 92354
Pacific Shores Medical Group
Long Beach, California, United States, 90813
Ucla Dept. Of Medicine
Los Angeles, California, United States, 90095
Ventura County Hematology-Oncology Specialists
Oxnard, California, United States, 93030
Kaiser Permanente Medical Center
Vallejo, California, United States, 94589
United States, District of Columbia
Georgetown University Med Ctr
Washington, District of Columbia, United States, 20007
Washington Cancer Institute At Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
University Of Florida
Gainesville, Florida, United States, 32610
University Of Miami
Miami, Florida, United States, 33136
Md Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
United States, Georgia
Emory University School Of Medicine
Atlanta, Georgia, United States, 30322
Georgia Cancer Specialists
Atlanta, Georgia, United States, 30341
Gwinnett Hospital System Inc.
Lawrenceville, Georgia, United States, 30046
United States, Illinois
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, United States, 60611
University Of Chicago
Chicago, Illinois, United States, 60637
Oncology Hematology Associates Of Central Illinois, Pc
Peoria, Illinois, United States, 61615
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Kansas
University Of Kansas Medical Center
Westwood, Kansas, United States, 66205
United States, Kentucky
University Of Kentucky
Lexington, Kentucky, United States, 40536
United States, Maryland
University Of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Dana Faber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Missouri
Washington University School Of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Devetten, Marcel
Omaha, Nebraska, United States, 68198
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, New Jersey
The Cancer Center At Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
The Cancer Institute Of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, New York
New York Presbyterian Hospital
New York, New York, United States, 10021
United States, North Carolina
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Ut Southwestern Medical Center
Dallas, Texas, United States, 75390
The University Of Texas Md Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Argentina
Local Institution
La Plata, Buenos Aires, Argentina, 1900
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Buenos Aires, Argentina, 1221
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Capital Federal, Argentina, 1280
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Cordoba, Argentina, X5016KEH
Australia, New South Wales
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Camperdown, New South Wales, Australia, 2050
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St Leonards, New South Wales, Australia, 2065
Australia, Queensland
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South Brisbane, Queensland, Australia, 4101
Australia, South Australia
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Adelaide, South Australia, Australia, SA 5000
Australia, Victoria
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East Melbourne, Victoria, Australia, 3002
Australia, Western Australia
Local Institution
Perth, Western Australia, Australia, WA 6000
Austria
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Wien, Austria, 1090
Belgium
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B-leuven, Belgium, 3000
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Brugge, Belgium, 8000
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Bruxelles, Belgium, 1000
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Charleroi, Belgium, 6000
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Edegem, Belgium, 2650
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Yvoir, Belgium, 5530
Brazil
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Curitiba, Parana, Brazil, 80060
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CEP - Campinas, Brazil, 13083
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Rio de Janeiro, Brazil, 20231
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San Paulo, Sp, Brazil, 05403
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Sao Paulo, Brazil, 05652
Canada, Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
Canada, Quebec
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Montreal, Quebec, Canada, H2W 1S6
Czech Republic
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Brno, Czech Republic, 625 00
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Prague 2, Czech Republic, 128 20
Denmark
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Aarhus C, Denmark, 8000
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Herlev, Denmark, 2730
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Odense C, Denmark, 5000
Finland
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Helsinki, Finland, 00029
France
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Cedex, Pierre Benite, France, 69495
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Caen, France, 14000
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Creteil Cedex, France, 94010
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Grenoble Cedex 09, France, 38043
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Lille Cedex, France, 59037
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Marseille Cedex 9, France, 13273
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Nantes, France, 44000
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Paris Cedex 10, France, 75475
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Poitiers Cedex, France, 86021
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Strasbourg, France, 67091
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Toulouse Cedex 9, France, 31059
Germany
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Dresden, Germany, 01307
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Frankfurt/main, Germany, 60590
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Hamburg, Germany, 20246
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Leipzig, Germany, 04103
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Mainz, Germany, 55131
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Mannheim, Germany, 68167
Hungary
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Budapest, Hungary, 1135
Ireland
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Co Galway, Galway, Ireland
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Dublin, Ireland, 8
Israel
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Ramat-gan, Israel, 52621
Italy
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Bari, Italy, 70124
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Monza (mi), Italy, 20052
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Napoli, Italy, 80131
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Orbassano, Italy, 10043
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Roma, Italy, 00144
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Roma, Italy, 00161
Korea, Republic of
Local Institution
Jeollanam-do, Korea, Republic of, 519-809
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Kyunggi-do, Korea, Republic of, 480-130
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Seoul, Korea, Republic of, 110-744
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Seoul, Korea, Republic of, 138-736
Mexico
Local Institution
Distrito Federal, Mexico, 02990
Netherlands
Local Institution
Nijmegen, Netherlands, 6525 GA
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Rotterdam, Netherlands, 3075 EA
Norway
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Trondheim, Norway, 7006
Peru
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Jesus Maria, Lima, Peru, 11
Local Institution
Lima, Peru, 34
Philippines
Local Institution
Quezon City, Philippines, 1102
Poland
Local Institution
Gdansk, Poland, 80 211
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Katowice, Poland, 40032
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Krakow, Poland, 31501
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Lodz, Poland, 93510
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Lublin, Poland, 20 950
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Warsaw, Poland, 02097
Russian Federation
Local Institution
Moscow, Russian Federation, 125167
Local Institution
St.petersburg, Russian Federation, 197022
Singapore
Local Institution
Singapore, Singapore, 169608
South Africa
Local Institution
Bloemfontein, Free State, South Africa, 9301
Local Institution
Groenkloof, Gauteng, South Africa, 0181
Local Institution
Parktown, Gauteng, South Africa, 2193
Local Institution
Soweto, Gauteng, South Africa, 2013
Local Institution
Observatory, Western Cape, South Africa, 7925
Spain
Local Institution
Madrid, Spain, 28034
Local Institution
Madrid, Spain, 28006
Local Institution
Pamplona, Spain, 31008
Sweden
Local Institution
Lund, Sweden, 22185
Local Institution
Uppsala, Sweden, 751 85
Switzerland
Local Institution
Basel, Switzerland, 4031
Taiwan
Local Institution
Taipei, Taiwan, 100
Local Institution
Taoyuan County, Taiwan, 333
United Kingdom
Local Institution
Cambridge, Cambridgeshire, United Kingdom, CB2 2XY
Local Institution
London, Greater London, United Kingdom, W12 OHS
Local Institution
Liverpool, Merseyside, United Kingdom, L7 8XP
Local Institution
Newcastle, Tyne And Wear, United Kingdom, NE2 2DR
Local Institution
Birmingham, West Midlands, United Kingdom, B15 2TH
Local Institution
Glasgow, United Kingdom, G12 0ZD
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00123474     History of Changes
Other Study ID Numbers: CA180-034
Study First Received: July 21, 2005
Results First Received: June 29, 2015
Last Updated: July 29, 2015
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia, Myeloid, Chronic-Phase
Bone Marrow Diseases
Hematologic Diseases
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Dasatinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on September 01, 2015