A Phase III Study of Dasatinib vs Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia

NCT00481247 | Completed Phase 3 Results DMC

• 2 other identifiers: CA180-0562006-005712-27
• Study Type: interventional
• Target: 547
• Locations: 26 countries
• Sites: 107

Brief Summary

The purpose of this clinical research study is to compare the confirmed complete cytogenetic response of dasatinib with that of imatinib within 12 months after randomization in patients with newly diagnosed chronic-phase Philadelphia positive chronic myeloid leukemia. The safety of this treatment will also be studied.

Conditions

Myeloid Leukemia, Chronic

Keywords

Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months

  Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from bone marrow (BM) sample. (Ideally, 25 metaphases but at least 20 metaphases from a BM sample were evaluated). Complete Cytogenetic Response (CCyR)=0% Ph+ cells in metaphase in BM. A cCCyR=those in which all measurements up to at least 28 days after the initial response show an equivalent or better CCyR.

  Pretreatment, every 3 months up to 12 months

Secondary Outcomes (6)

• Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR)

  Years 2, 3, 4 and 5

• Percentage of Participants With Major Molecular Response (MMR) at Any Time

  Planned total follow-up duration of 5 years

• Time to Confirmed Complete Cytogenic Response (cCCyR) Overall

  Day 1 to 5 years

• Time to Major Molecular Response (MMR) Overall

  Day 1 to 5 years

• Percentage of Participants With Progression-free Survival (PFS)

  Participants were followed-up for at least 5 years

Other Outcomes (2)

• Number of Participants With Adverse Events (AEs), Drug-related AEs, Drug-related Serious Adverse Events (SAEs), Drug-related AEs Leading to Discontinuation, and All Deaths

  From date of last person, first visit to date of last person, last visit (approximately 8 years)

• Number of Participants With Grade 3/4 Abnormalities in On-study Laboratory Test Results

  From date of last person, first visit to date of last person, last visit (approximately 8 years)

Study Arms (2)

Dasatinib

EXPERIMENTAL

Drug: Dasatinib

Imatinib

ACTIVE COMPARATOR

Drug: Imatinib

Interventions

Dasatinib DRUG

Tablets, oral, dasatinib 50-140 mg once daily (QD)

Also known as: Sprycel®, BMS-354825

Dasatinib

Imatinib DRUG

Tablets, oral, imatinib 200-800 mg, QD

Imatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged 18 years and older
• Chronic phase, Philadelphia Chromosome-positive chronic myeloid leukemia (CML)
• Eastern Cooperative Oncology Group Performance Status score of 0-2

You may not qualify if:

• Pleural Effusion
• Uncontrolled cardiovascular disease
• Significant bleeding disorder unrelated to CML
• Prior treatment with interferon/imatinib/dasatinib/anti-CML systemic treatments except anagrelide/hydroxyurea

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (109)

Molecular Md

Portland, Oregon, 97219, United States

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Buenos Aires, Buenos Aires, 1021, Argentina

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Capital Federal, Buenos Aires, 1280, Argentina

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Capital Federal, Buenos Aires, C1114AAN, Argentina

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Waratah, New South Wales, 2298, Australia

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Brisbane, Queensland, 4029, Australia

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Greenslopes, Queensland, 4120, Australia

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Perth, Western Australia, WA 6000, Australia

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Innsbruck, 6020, Austria

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Vienna, 1090, Austria

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Bruges, 8000, Belgium

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Brussels, 1200, Belgium

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Curitiba, Paraná, 80060, Brazil

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Rio de Janeiro, Rio de Janeiro, 20230130, Brazil

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Campinas, São Paulo, 13083, Brazil

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Jaú, São Paulo, 17210, Brazil

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São Paulo, São Paulo, 01401, Brazil

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São Paulo, São Paulo, 05403, Brazil

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Santiago, Santiago Metropolitan, Chile

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Beijing, Beijing Municipality, 100044, China

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Fuzhou, Fujian, 350001, China

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Shanghai, Shanghai Municipality, 200025, China

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Tianjin, Tianjin Municipality, 300020, China

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Colombia, Bogota D.C., Colombia

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Bogotá, Colombia

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Brno, 625 00, Czechia

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Hradec Králové, 500 05, Czechia

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Olomouc, 775 20, Czechia

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Prague, 128 20, Czechia

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Aarhus, 8000, Denmark

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Nantes, Cedex 1, 44093, France

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Brest, 29609, France

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Lille, 59037, France

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Limoges, 87042, France

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Montpellier, 34295, France

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Paris, 75015, France

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Paris, 75475, France

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Pierre-Bénite, 69495, France

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Poitiers, 86021, France

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Rennes, 35033, France

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Strasbourg, 67091, France

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Toulouse, 31059, France

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Vandœuvre-lès-Nancy, 54511, France

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Berlin, 13353, Germany

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Rostock, 18055, Germany

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Tübingen, 72076, Germany

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Ulm, 89081, Germany

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Thessaloniki, 57010, Greece

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Budapest, 1097, Hungary

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Debrecen, 4012, Hungary

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Vellore, Tamil Nadu, 632004, India

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Ahmedabad, 380009, India

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Kochi, 682304, India

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Mumbai, 400010, India

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Mumbai, 400012, India

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Mumbai, 400014, India

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Trivandrum, 695011, India

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Bologna, 40138, Italy

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Catania, 95124, Italy

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Monza (mb), 20900, Italy

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Orbassano (to), 10043, Italy

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Pavia, 27100, Italy

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Roma, 00144, Italy

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Roma, 00161, Italy

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Nagoya, Aichi-ken, 466-8650, Japan

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Kamogawa-shi, Chiba, 2968602, Japan

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Fukuoka, Fukuoka, 814-0180, Japan

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Morioka, Iwate, 020-8505, Japan

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Kagoshima, Kagoshima-ken, 890-0064, Japan

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Yokohama, Kanagawa, 232-0024, Japan

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Kyoto, Kyoto, 6028566, Japan

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Sendai, Miyagi, Japan

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Okayama, Okayama-ken, 7008558, Japan

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Osaka, Osaka, 545-8586, Japan

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Bunkyo-ku, Tokyo, 113-8677, Japan

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Shinagawa-ku, Tokyo, 1418625, Japan

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Mexico City, Mexico City, 02990, Mexico

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Mexico City, Mexico City, 14000, Mexico

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Mexico, D. F., Mexico City, 06726, Mexico

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Monterrey, Nuevo León, 64460, Mexico

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Culiacán, Sinaloa, 80230, Mexico

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Groningen, 9700 RB, Netherlands

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Nijmegen, 6500 HB, Netherlands

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Arequipa, Arequipa, Peru

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Lima, Lima Province, 11, Peru

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Lima, Lima Province, 34, Peru

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Chorzów, 41-500, Poland

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Krakow, 31501, Poland

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Lodz, 93-510, Poland

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Poznan, 60869, Poland

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Warsaw, 02776, Poland

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Moscow, 125167, Russia

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Rostov-on-Don, 344022, Russia

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Saint Petersburg, 197022, Russia

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Singapore, 169865, Singapore

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Seoul, 137-040, South Korea

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Seoul, 138-736, South Korea

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A Coruña, 15706, Spain

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Barcelona, 08003, Spain

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Barcelona, 08036, Spain

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Barcelona, 08907, Spain

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Madrid, 28006, Spain

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Madrid, 28046, Spain

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Málaga, 29010, Spain

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Oviedo, 33006, Spain

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Salamanca, 37007, Spain

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Valencia, 46009, Spain

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Ankara, 06100, Turkey (Türkiye)

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Kayseri, 38039, Turkey (Türkiye)

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Related Publications (6)

• 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.

  PMID: 30120281 DERIVED

• 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.

  PMID: 26118315 DERIVED

• 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.

  PMID: 24357015 DERIVED

• 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.

  PMID: 24311723 DERIVED

• 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.

  PMID: 22160483 DERIVED

• 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.

  PMID: 20525995 DERIVED

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Dasatinib; Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines

Results Point of Contact

• Title: BMS Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2007
• First Posted: June 1, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2015
• Last Updated: February 15, 2017
• Results First Posted: March 15, 2011

Record last verified: 2016-12

Locations

AR (3); BE (2); HU (2); SG (1); US (1); ME (5); GR (1); IN (7); RU (3); KR (2); CL (1); AU (4); CZ (4); CO (2); NL (2); CN (4); JP (12); PL (5); BR (6); IT (7); PE (3); ES (10); DE (4); DK (1); FR (13); TU (2)