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

• ClinicalTrials.gov Identifier: NCT00123474
• Recruitment Status: Completed
• First Posted: July 25, 2005
• Results First Posted: August 26, 2015
• Last Update Posted: August 25, 2016
• Sponsor: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Myeloid Leukemia, Chronic, Chronic-Phase	Drug: dasatinib	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 724 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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)
• Study Start Date: July 2005
• Actual Primary Completion Date: September 2006
• Actual Study Completion Date: July 2014

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Percent of Participants With Major Cytogenetic Response (MCyR) at 6 Months Follow-Up [ Time Frame: 6 months ]
   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 :

1. Percent of Participants With MCyR At or Prior to 24 Months Follow-Up [ Time Frame: 24 months ]
   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.
2. Percent of Participants With Complete Hematologic Response (CHR) at 6 and 24 Months Follow-Up [ Time Frame: 6 months, 24 months ]
   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.
3. Time to MCyR in Participants With MCyR at 6 Months Follow-Up [ Time Frame: 6 months ]
   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).
4. Time to CHR in Participants With CHR at 6 Months Follow-Up [ Time Frame: 6 months ]
   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).
5. Time to MCyR in Participants With MCyR at 24 Months Follow-Up [ Time Frame: 24 months ]
   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.
6. Time to CHR in Participants With CHR At 24 Months Follow-Up [ Time Frame: 24 months ]
   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.
7. Number of Participants With MCyR Whose Disease Progressed by 24 Months [ Time Frame: 24 months ]
   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.
8. Number of Participants With CHR Whose Disease Progressed by 24 Months [ Time Frame: 24 months ]
   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.
9. Number of Participants With MCyR and Baseline BCR-ABL Gene Mutation - All Treated Participants [ Time Frame: Baseline up to 24 months ]
   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).
10. Percent of Imatinib-Resistant Participants With Progression Free Survival (PFS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up [ Time Frame: 24, 36, 48, 60, 72, and 84 months ]
    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.
11. Percent of Imatinib-Resistant Participants With Overall Survival (OS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up [ Time Frame: 24, 36, 48, 60, 72, and 84 months ]
    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.
12. Percent of Participants Intolerant to Imatinib With MCyR at 6 Months and at 24 Months Follow-Up, by QD and BID Schedules and by Total Daily Dose [ Time Frame: 6 months, 24 months ]
    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.
13. Percent of Participants Intolerant to Imatinib With CHR at 6 Months and at 24 Months Follow-Up [ Time Frame: 6 months, 24 months ]
    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.
14. Percent of Imatinib Intolerant Participants With Progression Free Survival After 24, 36, 48, 60, 72, and 84 Months of Follow-Up [ Time Frame: 24, 36, 48, 60, 72, and 84 months ]
    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.
15. Percent of Imatinib Intolerant Participants With Overall Survival After 24, 36, 48, 60, 72, and 84 Months of Follow-up [ Time Frame: 24, 36, 48, 60, 72, and 84 months ]
    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.
16. 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) at 6 Months Follow-Up [ Time Frame: 6 months ]
    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.
17. 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) at 24 Months Follow-Up [ Time Frame: 24 months ]
    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.
18. 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: 24, 36, 48, 60, 72, and 84 months ]
    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.
19. Percent of Participants Overall Survival at 24, 36, 48, 60, 72, and 84 Months Follow-Up - All Randomized Participants [ Time Frame: 24, 36, 48, 60, 72, and 84 months ]
    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.
20. Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led to Treatment Discontinuation at 24 Months of Follow-up [ Time Frame: Baseline to 30 days post last dose, up to 24 months ]
    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.
21. Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led toTreatment Discontinuation After 7 Year Follow-up [ Time Frame: Baseline to 30 days post last dose, up to 7 years (study closure July 2014) ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Nebraska Methodist Hospital

Omaha, Nebraska, United States, 68114

Devetten, Marcel

Omaha, Nebraska, United States, 68198

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

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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

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Lima, Peru, 34

Philippines

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Quezon City, Philippines, 1102

Poland

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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

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Moscow, Russian Federation, 125167

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St.petersburg, Russian Federation, 197022

Singapore

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Singapore, Singapore, 169608

South Africa

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Bloemfontein, Free State, South Africa, 9301

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Groenkloof, Gauteng, South Africa, 0181

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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, 28006

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Madrid, Spain, 28034

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Pamplona, Spain, 31008

Sweden

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Lund, Sweden, 22185

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Uppsala, Sweden, 751 85

Switzerland

Local Institution

Basel, Switzerland, 4031

Taiwan

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Taipei, Taiwan, 100

Local Institution

Taoyuan County, Taiwan, 333

United Kingdom

Local Institution

Cambridge, Cambridgeshire, United Kingdom, CB2 2XY

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London, Greater London, United Kingdom, W12 OHS

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Liverpool, Merseyside, United Kingdom, L7 8XP

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Newcastle, Tyne And Wear, United Kingdom, NE2 2DR

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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:

BMS clinical trial educational resource 

Publications:

Porkka K, Khoury HJ, Paquette RL, Matloub Y, Sinha R, Cortes JE. Dasatinib 100 mg once daily minimizes the occurrence of pleural effusion in patients with chronic myeloid leukemia in chronic phase and efficacy is unaffected in patients who develop pleural effusion. Cancer. 2010 Jan 15;116(2):377-86. doi: 10.1002/cncr.24734.

Muller MC, Cortes JE, Kim DW, Druker BJ, Erben P, Pasquini R, Branford S, Hughes TP, Radich JP, Ploughman L, Mukhopadhyay J, Hochhaus A. Dasatinib treatment of chronic-phase chronic myeloid leukemia: analysis of responses according to preexisting BCR-ABL mutations. Blood. 2009 Dec 3;114(24):4944-53. doi: 10.1182/blood-2009-04-214221. Epub 2009 Sep 24.

Shah NP, Kantarjian HM, Kim DW, Rea D, Dorlhiac-Llacer PE, Milone JH, Vela-Ojeda J, Silver RT, Khoury HJ, Charbonnier A, Khoroshko N, Paquette RL, Deininger M, Collins RH, Otero I, Hughes T, Bleickardt E, Strauss L, Francis S, Hochhaus A. Intermittent target inhibition with dasatinib 100 mg once daily preserves efficacy and improves tolerability in imatinib-resistant and -intolerant chronic-phase chronic myeloid leukemia. J Clin Oncol. 2008 Jul 1;26(19):3204-12. doi: 10.1200/JCO.2007.14.9260. Epub 2008 Jun 9.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Shah NP, Rousselot P, Schiffer C, Rea D, Cortes JE, Milone J, Mohamed H, Healey D, Kantarjian H, Hochhaus A, Saglio G. Dasatinib in imatinib-resistant or -intolerant chronic-phase, chronic myeloid leukemia patients: 7-year follow-up of study CA180-034. Am J Hematol. 2016 Sep;91(9):869-74. doi: 10.1002/ajh.24423. Epub 2016 Jun 20.

Shah NP, Guilhot F, Cortes JE, Schiffer CA, le Coutre P, Brummendorf TH, Kantarjian HM, Hochhaus A, Rousselot P, Mohamed H, Healey D, Cunningham M, Saglio G. Long-term outcome with dasatinib after imatinib failure in chronic-phase chronic myeloid leukemia: follow-up of a phase 3 study. Blood. 2014 Apr 10;123(15):2317-24. doi: 10.1182/blood-2013-10-532341. Epub 2014 Feb 25.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT00123474
• Other Study ID Numbers: CA180-034
• First Posted: July 25, 2005
• Results First Posted: August 26, 2015
• Last Update Posted: August 25, 2016
• Last Verified: July 2016

Keywords provided by Bristol-Myers Squibb:

Chronic Phase Chronic Myelogenous Leukemia

Additional relevant MeSH terms:

Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Dasatinib; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action