Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML
NCT ID: NCT00123474
Last Updated: 2016-08-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
724 participants
INTERVENTIONAL
2005-07-31
2014-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML
NCT00123487
Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia
NCT00103844
BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate
NCT00064233
Study of BMS-354825 in Subjects With CML Who Are Resistant to or Intolerant of Imatinib or Ph+All in Japan
NCT00337454
Study of Dasatinib (BMS-354825) in Patients With Accelerated Phase Chronic Myeloid Leukemia
NCT00101647
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
dasatinib
Tablets, Oral, 50 mg BID, indefinitely, survival study
2
dasatinib
Tablets, Oral, 70 mg BID, indefinitely, survival study
3
dasatinib
Tablets, Oral, 100 mg QD, indefinitely, survival study
4
dasatinib
Tablets, Oral, 140 mg QD, indefinitely, survival study
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
dasatinib
Tablets, Oral, 50 mg BID, indefinitely, survival study
dasatinib
Tablets, Oral, 70 mg BID, indefinitely, survival study
dasatinib
Tablets, Oral, 100 mg QD, indefinitely, survival study
dasatinib
Tablets, Oral, 140 mg QD, indefinitely, survival study
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Local Institution
Newcastle, Tyne and Wear, United Kingdom
Local Institution
Birmingham, West Midlands, United Kingdom
Local Institution
Glasgow, , United Kingdom
University Of Alabama At Birmingham
Birmingham, Alabama, United States
Central Hematology Oncology Medical Group Inc.
Alhambra, California, United States
Pacific Cancer Medical Center Inc
Anaheim, California, United States
Loma Linda University Cancer Center
Loma Linda, California, United States
Pacific Shores Medical Group
Long Beach, California, United States
Ucla Dept. Of Medicine
Los Angeles, California, United States
Ventura County Hematology-Oncology Specialists
Oxnard, California, United States
Kaiser Permanente Medical Center
Vallejo, California, United States
Georgetown University Med Ctr
Washington D.C., District of Columbia, United States
Washington Cancer Institute At Washington Hospital Center
Washington D.C., District of Columbia, United States
University Of Florida
Gainesville, Florida, United States
University Of Miami
Miami, Florida, United States
Md Anderson Cancer Center Orlando
Orlando, Florida, United States
Emory University School Of Medicine
Atlanta, Georgia, United States
Georgia Cancer Specialists
Atlanta, Georgia, United States
Gwinnett Hospital System Inc.
Lawrenceville, Georgia, United States
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, United States
University Of Chicago
Chicago, Illinois, United States
Oncology Hematology Associates Of Central Illinois, Pc
Peoria, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
University Of Kansas Medical Center
Westwood, Kansas, United States
University Of Kentucky
Lexington, Kentucky, United States
University Of Maryland
Baltimore, Maryland, United States
Dana Faber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Devetten, Marcel
Omaha, Nebraska, United States
Nevada Cancer Institute
Las Vegas, Nevada, United States
The Cancer Center At Hackensack University Medical Center
Hackensack, New Jersey, United States
The Cancer Institute Of New Jersey
New Brunswick, New Jersey, United States
New York Presbyterian Hospital
New York, New York, United States
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Ut Southwestern Medical Center
Dallas, Texas, United States
The University Of Texas Md Anderson Cancer Center
Houston, Texas, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Local Institution
La Plata, Buenos Aires, Argentina
Local Institution
Buenos Aires, , Argentina
Local Institution
Capital Federal, , Argentina
Local Institution
Córdoba, , Argentina
Local Institution
Camperdown, New South Wales, Australia
Local Institution
St Leonards, New South Wales, Australia
Local Institution
South Brisbane, Queensland, Australia
Local Institution
Adelaide, South Australia, Australia
Local Institution
East Melbourne, Victoria, Australia
Local Institution
Perth, Western Australia, Australia
Local Institution
Vienna, , Austria
Local Institution
B-leuven, , Belgium
Local Institution
Bruges, , Belgium
Local Institution
Brussels, , Belgium
Local Institution
Charleroi, , Belgium
Local Institution
Edegem, , Belgium
Local Institution
Yvoir, , Belgium
Local Institution
Curitiba, Paraná, Brazil
Local Institution
Rio de Janeiro, Rio de Janeiro, Brazil
Local Institution
São Paulo, São Paulo, Brazil
Local Institution
CEP - Campinas, , Brazil
Local Institution
San Paulo, Sp, , Brazil
Local Institution
Edmonton, Alberta, Canada
Local Institution
Hamilton, Ontario, Canada
Local Institution
Montreal, Quebec, Canada
Local Institution
Brno, , Czechia
Local Institution
Prague, , Czechia
Local Institution
Aarhus C, , Denmark
Local Institution
Herlev, , Denmark
Local Institution
Odense C, , Denmark
Local Institution
Helsinki, , Finland
Local Institution
Cedex, Pierre Benite, France
Local Institution
Caen, , France
Local Institution
Créteil, , France
Local Institution
Grenoble, , France
Local Institution
Lille, , France
Local Institution
Marseille, , France
Local Institution
Nantes, , France
Local Institution
Paris, , France
Local Institution
Poitiers, , France
Local Institution
Strasbourg, , France
Local Institution
Toulouse, , France
Local Institution
Dresden, , Germany
Local Institution
Frankfurt am Main, , Germany
Local Institution
Hamburg, , Germany
Local Institution
Leipzig, , Germany
Local Institution
Mainz, , Germany
Local Institution
Mannheim, , Germany
Local Institution
Budapest, , Hungary
Local Institution
Co Galway, Galway, Ireland
Local Institution
Dublin, , Ireland
Local Institution
Ramat Gan, , Israel
Local Institution
Bari, , Italy
Local Institution
Monza (mi), , Italy
Local Institution
Napoli, , Italy
Local Institution
Orbassano, , Italy
Local Institution
Roma, , Italy
Local Institution
Roma, , Italy
Local Institution
Distrito Federal, , Mexico
Local Institution
Nijmegen, , Netherlands
Local Institution
Rotterdam, , Netherlands
Local Institution
Trondheim, , Norway
Local Institution
Lima, Lima Province, Peru
Local Institution
Jesus Maria, Lima region, Peru
Local Institution
Quezon City, , Philippines
Local Institution
Gdansk, , Poland
Local Institution
Katowice, , Poland
Local Institution
Krakow, , Poland
Local Institution
Lodz, , Poland
Local Institution
Lublin, , Poland
Local Institution
Warsaw, , Poland
Local Institution
Moscow, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Singapore, , Singapore
Local Institution
Bloemfontein, Free State, South Africa
Local Institution
Groenkloof, Gauteng, South Africa
Local Institution
Parktown, Gauteng, South Africa
Local Institution
Soweto, Gauteng, South Africa
Local Institution
Observatory, Western Cape, South Africa
Local Institution
Jeollanam-do, , South Korea
Local Institution
Kyunggi-do, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Madrid, , Spain
Local Institution
Madrid, , Spain
Local Institution
Pamplona, , Spain
Local Institution
Lund, , Sweden
Local Institution
Uppsala, , Sweden
Local Institution
Basel, , Switzerland
Local Institution
Taipei, , Taiwan
Local Institution
Taoyuan, , Taiwan
Local Institution
Cambridge, Cambridgeshire, United Kingdom
Local Institution
London, Greater London, United Kingdom
Local Institution
Liverpool, Merseyside, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CA180-034
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.