A Phase III Study of Dasatinib vs Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
NCT ID: NCT00481247
Last Updated: 2017-02-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
547 participants
INTERVENTIONAL
2007-09-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dasatinib
Dasatinib
Tablets, oral, dasatinib 50-140 mg once daily (QD)
Imatinib
Imatinib
Tablets, oral, imatinib 200-800 mg, QD
Interventions
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Dasatinib
Tablets, oral, dasatinib 50-140 mg once daily (QD)
Imatinib
Tablets, oral, imatinib 200-800 mg, QD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic phase, Philadelphia Chromosome-positive chronic myeloid leukemia (CML)
* Eastern Cooperative Oncology Group Performance Status score of 0-2
Exclusion Criteria
* Uncontrolled cardiovascular disease
* Significant bleeding disorder unrelated to CML
* Prior treatment with interferon/imatinib/dasatinib/anti-CML systemic treatments except anagrelide/hydroxyurea
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Molecular Md
Portland, Oregon, United States
Local Institution
Buenos Aires, Buenos Aires, Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina
Local Institution
Waratah, New South Wales, Australia
Local Institution
Brisbane, Queensland, Australia
Local Institution
Greenslopes, Queensland, Australia
Local Institution
Perth, Western Australia, Australia
Local Institution
Innsbruck, , Austria
Local Institution
Vienna, , Austria
Local Institution
Bruges, , Belgium
Local Institution
Brussels, , Belgium
Local Institution
Curitiba, Paraná, Brazil
Local Institution
Rio de Janeiro, Rio de Janeiro, Brazil
Local Institution
Campinas, São Paulo, Brazil
Local Institution
Jaú, São Paulo, Brazil
Local Institution
São Paulo, São Paulo, Brazil
Local Institution
São Paulo, São Paulo, Brazil
Local Institution
Santiago, Santiago Metropolitan, Chile
Local Institution
Beijing, Beijing Municipality, China
Local Institution
Fuzhou, Fujian, China
Local Institution
Shanghai, Shanghai Municipality, China
Local Institution
Tianjin, Tianjin Municipality, China
Local Institution
Colombia, Bogota D.C., Colombia
Local Institution
Bogotá, , Colombia
Local Institution
Brno, , Czechia
Local Institution
Hradec Králové, , Czechia
Local Institution
Olomouc, , Czechia
Local Institution
Prague, , Czechia
Local Institution
Aarhus, , Denmark
Local Institution
Nantes, Cedex 1, France
Local Institution
Brest, , France
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Lille, , France
Local Institution
Limoges, , France
Local Institution
Montpellier, , France
Local Institution
Paris, , France
Local Institution
Paris, , France
Local Institution
Pierre-Bénite, , France
Local Institution
Poitiers, , France
Local Institution
Rennes, , France
Local Institution
Strasbourg, , France
Local Institution
Toulouse, , France
Local Institution
Vandœuvre-lès-Nancy, , France
Local Institution
Berlin, , Germany
Local Institution
Rostock, , Germany
Local Institution
Tübingen, , Germany
Local Institution
Ulm, , Germany
Local Institution
Thessaloniki, , Greece
Local Institution
Budapest, , Hungary
Local Institution
Debrecen, , Hungary
Local Institution
Vellore, Tamil Nadu, India
Local Institution
Ahmedabad, , India
Local Institution
Kochi, , India
Local Institution
Mumbai, , India
Local Institution
Mumbai, , India
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Mumbai, , India
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Trivandrum, , India
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Bologna, , Italy
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Catania, , Italy
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Monza (mb), , Italy
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Orbassano (to), , Italy
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Pavia, , Italy
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Roma, , Italy
Local Institution
Roma, , Italy
Local Institution
Nagoya, Aichi-ken, Japan
Local Institution
Kamogawa-shi, Chiba, Japan
Local Institution
Fukuoka, Fukuoka, Japan
Local Institution
Morioka, Iwate, Japan
Local Institution
Kagoshima, Kagoshima-ken, Japan
Local Institution
Yokohama, Kanagawa, Japan
Local Institution
Kyoto, Kyoto, Japan
Local Institution
Sendai, Miyagi, Japan
Local Institution
Okayama, Okayama-ken, Japan
Local Institution
Osaka, Osaka, Japan
Local Institution
Bunkyo-ku, Tokyo, Japan
Local Institution
Shinagawa-ku, Tokyo, Japan
Local Institution
Mexico City, Mexico City, Mexico
Local Institution
Mexico City, Mexico City, Mexico
Local Institution
Mexico, D. F., Mexico City, Mexico
Local Institution
Monterrey, Nuevo León, Mexico
Local Institution
Culiacán, Sinaloa, Mexico
Local Institution
Groningen, , Netherlands
Local Institution
Nijmegen, , Netherlands
Local Institution
Arequipa, Arequipa, Peru
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Lima, Lima Province, Peru
Local Institution
Lima, Lima Province, Peru
Local Institution
Chorzów, , Poland
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Krakow, , Poland
Local Institution
Lodz, , Poland
Local Institution
Poznan, , Poland
Local Institution
Warsaw, , Poland
Local Institution
Moscow, , Russia
Local Institution
Rostov-on-Don, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Singapore, , Singapore
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
A Coruña, , Spain
Local Institution
Barcelona, , Spain
Local Institution
Barcelona, , Spain
Local Institution
Barcelona, , Spain
Local Institution
Madrid, , Spain
Local Institution
Madrid, , Spain
Local Institution
Málaga, , Spain
Local Institution
Oviedo, , Spain
Local Institution
Salamanca, , Spain
Local Institution
Valencia, , Spain
Local Institution
Ankara, , Turkey (Türkiye)
Local Institution
Kayseri, , Turkey (Türkiye)
Countries
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References
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Glauche I, Kuhn M, Baldow C, Schulze P, Rothe T, Liebscher H, Roy A, Wang X, Roeder I. Quantitative prediction of long-term molecular response in TKI-treated CML - Lessons from an imatinib versus dasatinib comparison. Sci Rep. 2018 Aug 17;8(1):12330. doi: 10.1038/s41598-018-29923-4.
Hughes TP, Saglio G, Quintas-Cardama A, Mauro MJ, Kim DW, Lipton JH, Bradley-Garelik MB, Ukropec J, Hochhaus A. BCR-ABL1 mutation development during first-line treatment with dasatinib or imatinib for chronic myeloid leukemia in chronic phase. Leukemia. 2015 Sep;29(9):1832-8. doi: 10.1038/leu.2015.168. Epub 2015 Jun 29.
Fujisawa S, Nakamae H, Ogura M, Ishizawa K, Taniwaki M, Utsunomiya A, Matsue K, Takamatsu Y, Usuki K, Tanimoto M, Ishida Y, Akiyama H, Onishi S. Efficacy and safety of dasatinib versus imatinib in Japanese patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP): Subset analysis of the DASISION trial with 2-year follow-up. Int J Hematol. 2014 Feb;99(2):141-53. doi: 10.1007/s12185-013-1470-1. Epub 2013 Dec 20.
Jabbour E, Kantarjian HM, Saglio G, Steegmann JL, Shah NP, Boque C, Chuah C, Pavlovsky C, Mayer J, Cortes J, Baccarani M, Kim DW, Bradley-Garelik MB, Mohamed H, Wildgust M, Hochhaus A. Early response with dasatinib or imatinib in chronic myeloid leukemia: 3-year follow-up from a randomized phase 3 trial (DASISION). Blood. 2014 Jan 23;123(4):494-500. doi: 10.1182/blood-2013-06-511592. Epub 2013 Dec 5.
Kantarjian HM, Shah NP, Cortes JE, Baccarani M, Agarwal MB, Undurraga MS, Wang J, Ipina JJ, Kim DW, Ogura M, Pavlovsky C, Junghanss C, Milone JH, Nicolini FE, Robak T, Van Droogenbroeck J, Vellenga E, Bradley-Garelik MB, Zhu C, Hochhaus A. Dasatinib or imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: 2-year follow-up from a randomized phase 3 trial (DASISION). Blood. 2012 Feb 2;119(5):1123-9. doi: 10.1182/blood-2011-08-376087. Epub 2011 Dec 9.
Kantarjian H, Shah NP, Hochhaus A, Cortes J, Shah S, Ayala M, Moiraghi B, Shen Z, Mayer J, Pasquini R, Nakamae H, Huguet F, Boque C, Chuah C, Bleickardt E, Bradley-Garelik MB, Zhu C, Szatrowski T, Shapiro D, Baccarani M. Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2010 Jun 17;362(24):2260-70. doi: 10.1056/NEJMoa1002315. Epub 2010 Jun 5.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2006-005712-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA180-056
Identifier Type: -
Identifier Source: org_study_id
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