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A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) (ENESTnd)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00471497
First received: May 7, 2007
Last updated: November 19, 2014
Last verified: November 2014
  Purpose

In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, will be compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).


Condition Intervention Phase
Myelogenous Leukemia, Chronic
Drug: nilotinib
Drug: imatinib
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 Phase III Multi-center, Open-label, Randomized Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Molecular Response Rate (MMR) at 12 Months [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
    Rate of MMR is defined as <= 0.1% BCR-ABL/ABL ratio by international scale (IS), measured by real-time quantitative polymerase chain reaction (RQ-PCR) which corresponds to a ≥ 3 log reduction of BCR-ABL transcript from standardized baseline. BCR-ABL = fusion gene from BCR (breakpoint cluster region gene/BCR gene product) and ABL (Abelson protooncogene)


Secondary Outcome Measures:
  • Rate of Durable MMR at 24 Months. [ Time Frame: Baseline, 24 months ] [ Designated as safety issue: No ]
  • Rate Reduction in BCR-ABL Transcript Levels in Nilotinib Treatment Arms With Imatinib at 12 Months [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
  • Rate of Complete Cytogenetic Response (CCyR) in Nilotinib Treatment Arms With Imatinib at 12 Months [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]

Enrollment: 846
Study Start Date: July 2007
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nilotinib 300mg bid (investigating arm) Drug: nilotinib
Nilotinib was supplied as 50 mg, 150 mg and 200 mg hard gelatin capsules and administered orally at 300 mg BID (twice a day) or 400 mg BID (twice a day)depending on the randomized dose.
Other Name: AMN107
Experimental: Nilotinb 400 mg bid (investigating arm) Drug: nilotinib
Nilotinib was supplied as 50 mg, 150 mg and 200 mg hard gelatin capsules and administered orally at 300 mg BID (twice a day) or 400 mg BID (twice a day)depending on the randomized dose.
Other Name: AMN107
Experimental: imatinib 400mg QD (control arm) Drug: imatinib
Imatinib was supplied as 100 mg and 400 mg tablets and administered orally at 400 mg QD (once a day).
Other Name: STI571

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Chronic myelogenous leukemia in chronic phase patients within the first 6 months of diagnosis.
  • Diagnosis of chronic myelogenous leukemia in chronic phase with confirmation of Philadelphia chromosome

Exclusion criteria:

  • Treatment with a tyrosine kinase inhibitor prior to study entry is not allowed except for no more than 2 weeks in duration of imatinib
  • Any medical treatment for CML prior to study entry for longer than 2 weeks with the exception of hydroxyurea and/or anagrelide
  • Uncontrolled or significant cardiovascular disease.
  • Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).
  • Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon)
  • Currently taking certain medications that could affect the rhythm of your heart.

Other protocol-defined inclusion/exclusion criteria may apply

  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: NCT00471497

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Locations
United States, California
University of California at Los Angeles Dept. of Hematology Clinic
Los Angeles, California, United States, 90095
Kaiser Permanente - California Southern Dept of Kaiser South 3
San Diego, California, United States, 90027
Kaiser Permanente - California Southern Dept of Kaiser South 9
San Diego, California, United States, 90027
Kaiser Permanente - California Southern San Diego Zion Avenue
San Diego, California, United States, 90027
Kaiser Permanente - California Northern Kaiser Med
Vallejo, California, United States
Kaiser Permanente - California Northern Vallejo Med Center/Med Offices
Vallejo, California, United States
United States, Colorado
Rocky Mountain Cancer Centers RMCC - Colorado Springs
Greenwood Village, Colorado, United States
United States, Florida
Florida Cancer Specialists Dept. FloridaCancerSpecialists
Fort Myers, Florida, United States, 33901
Advanced Medical Specialties Research Dept.
Miami, Florida, United States, 33176
Florida Cancer Institute Flordia Cancer Affilates
New Port Richey, Florida, United States, 34655
Cancer Centers of Florida PA Cancer Centers of FL
Ocoee, Florida, United States, *see dep*
United States, Illinois
University of Chicago Medical Center Section of Hematology/Oncology
Chicago, Illinois, United States, 60546
United States, Indiana
Indiana Blood and Marrow Institute Dept. of Indiana Blood&Marrow
Beach Grove, Indiana, United States, 46107
United States, Iowa
University of Iowa Hospitals and Clinics Dept.of U of Iowa Hosp&Clinics
Iowa City, Iowa, United States, 52242
United States, Kansas
Kansas City Cancer Center KCCC Business Office
Overland Park, Kansas, United States, 66210
United States, Louisiana
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center
New Orleans, Louisiana, United States, 70115
United States, Michigan
Michigan State University / Breslin Cancer Center Breslin Cancer Center
Lansing, Michigan, United States
United States, Missouri
Missouri Cancer Associates Dept. of Boone Hospital Center
Columbia, Missouri, United States, 65201
Hematology Oncology Consultants, Inc. Deptof Hem. Onc.Consunsultants
St. Louis, Missouri, United States, 63136
United States, New Jersey
Hackensack University Medical Center Department of Research
Hackensack, New Jersey, United States, 07601
United States, New York
Memorial Sloan Kettering Cancer Center Clinical Trials Office
New York, New York, United States, 10021
United States, North Carolina
University of North Carolina UNC Lineberger Cancer Center
Chapel Hill, North Carolina, United States, 27514
Cancer Centers of North Carolina Cancer Centers of NC-Raleigh
Raleigh, North Carolina, United States, 27609
Wake Forest University Baptist Medical Center Dept. of Industry Research
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University of Cincinnati / Barrett Cancer Center Dept.of Internal Med.
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Foundation CCF
Cleveland, Ohio, United States, 44195
United States, Oregon
Northwest Cancer Specialists Compass Oncology -BKM
Portland, Oregon, United States, 97210
United States, South Carolina
Cancer Centers of the Carolinas CC of C -Eastside
Greenville, South Carolina, United States, 29605
United States, Tennessee
Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology Dept. of Centennial Medical
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Cancer Center ( Medical City Dallas Hospital)
Dallas, Texas, United States, 75230
Cancer Care Centers of South Texas / HOAST CCC of So.TX- Medical Center
San Antonio, Texas, United States, 78229
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Utah
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84106
Argentina
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Caba, Buenos Aires, Argentina, C1221ADC
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La Plata, Buenos Aires, Argentina, B1902AVG
Austria
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Salzburg, Austria, 5020
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Wien, Austria, A-1090
Belgium
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Bruxelles, Belgium, 1000
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Charleroi, Belgium, 6000
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Gent, Belgium, 9000
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Leuven, Belgium, 3000
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Yvoir, Belgium, 5530
Brazil
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Brasilia, DF, Brazil, 70330-150
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Curitiba, PR, Brazil, 80060-900
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Campinas, SP, Brazil, 13083-970
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Jaú, SP, Brazil, 17210-080
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Sao Paulo, SP, Brazil, 05403-000
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São Paulo, SP, Brazil, 01224-000
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São Paulo, SP, Brazil, 01401-901
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Vancouver, British Columbia, Canada, V5Z 4E6
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Toronto, Ontario, Canada, M5G 2M9
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Quebec, Canada, G1R 2J6
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Bogotá, Cundinamarca, Colombia, 110111
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Olomouc, CZE, Czech Republic, 775 20
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Praha 2, Czech Republic, 128 20
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Copenhagen, Denmark, DK-2100
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Vejle, Denmark, DK-7100
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Cairo, Egypt
Finland
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HUS Helsinki, Finland, FIN-00029
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Turku, Finland, FIN-20521
France
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Caen, Cedex, France, 14033
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Angers Cedex 1, France, 49033
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Bordeaux, France, 33076
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Créteil, France, 94010
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Grenoble, France, 38043
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Lille, France, 59037
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Marseille, France, 13273
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Nice Cedex, France, 06202
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Paris, France, 75475
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Pierre-Benite Cédex, France, F-69495
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Poitiers, France, 86021
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Rennes, France, 35019
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Saint Priest en Jarez Cedex, France, 42271
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Toulouse Cedex 9, France, 31059
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Vandoeuvre les Nancy, France, 54511
Germany
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Berlin, Germany, 13353
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Duesseldorf, Germany, 40225
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Eisenach, Germany, 99817
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Frankfurt, Germany, 60590
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Hamburg, Germany, 20246
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Kiel, Germany, D-24116
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Koeln, Germany, 50937
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Leipzig, Germany, 04103
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Mannheim, Germany, 68169
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Muenchen, Germany, 81675
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Ulm, Germany, 89081
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Hungary
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Budapest, Hungary, 1097
Italy
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Bari, BA, Italy, 70124
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Catania, CT, Italy, 95124
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Firenze, FI, Italy, 50134
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Genova, GE, Italy, 16132
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Milano, MI, Italy, 20162
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Pescara, PE, Italy, 65124
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Pisa, PI, Italy, 56126
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Pavia, PV, Italy, 27100
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Reggio Calabria, RC, Italy, 89124
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Roma, RM, Italy, 00133
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Roma, RM, Italy, 00161
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Roma, RM, Italy, 00144
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Siena, SI, Italy, 53100
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Udine, UD, Italy, 33100
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Napoli, Italy, 80132
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Napoli, Italy, 80131
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Perugia, Italy, 06129
Japan
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Nagoya-city, Aichi, Japan, 466-8560
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Nagoya-city, Aichi, Japan, 453-8511
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Chiba-city, Chiba, Japan, 260-8677
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Maebashi, Gunma, Japan, 371-0821
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Maebashi-city, Gunma, Japan, 371-8511
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Hiroshima-city, Hiroshima, Japan, 734-8551
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Sapporo, Hokkaido, Japan, 003-0006
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Sapporo-city, Hokkaido, Japan, 060-8648
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Nishinomiya, Hyogo, Japan, 663-8501
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Tsukuba-city, Ibaraki, Japan, 305-8576
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Kanazawa, Ishikawa, Japan, 920-8641
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Kumamoto City, Kumamoto, Japan, 860-8556
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Tsu-city, Mie, Japan, 514-8507
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Niigata-city, Niigata, Japan, 951-8520
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Osaka-city, Osaka, Japan, 545-8586
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OsakaSayama, Osaka, Japan, 589-8511
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Suita-city, Osaka, Japan, 565-0871
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Hidaka, Saitama, Japan, 350-1298
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Hamamatsu, Shizuoka, Japan, 431-3192
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Shimotsuke-city, Tochigi, Japan, 329-0498
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Bunkyo-ku, Tokyo, Japan, 113-8519
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Bunkyo-ku, Tokyo, Japan, 113-8655
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Chuo-ku, Tokyo, Japan, 104-0045
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Shinagawa-ku, Tokyo, Japan, 141-8625
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Shinjuku-ku, Tokyo, Japan, 160-0023
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Shinjuku-ku, Tokyo, Japan, 160-8582
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Akita, Japan, 010-8543
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Nagasaki, Japan, 852-8501
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Saitama, Japan, 330-8503
Korea, Republic of
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Hwasun-gun, Jeollanam-do, Korea, Republic of, 519-809
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Seoul, Korea, Korea, Republic of, 135-710
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Seoul, Korea, Korea, Republic of, 110 744
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Seoul, Korea, Republic of, 137-701
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Seoul, Korea, Republic of, 738-736
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Taegu, Korea, Republic of, 700 - 721
Malaysia
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Selangor, Malaysia, 68000
Mexico
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Mexico, Distrito Federal, Mexico, 06726
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Monterrey, Nuevo León, Mexico, 64460
Netherlands
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Amsterdam, Netherlands, 1081 HV
Norway
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Oslo, Norway, NO-0027
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Trondheim, Norway, 7006
Poland
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Katowice, Poland, 40032
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Lublin, Poland, 20-081
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Rzeszow, Poland, 35-055
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Warszawa, Poland, 02-097
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Wroclaw, Poland, 50-367
Portugal
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Lisboa, Portugal, 1099 - 023
Russian Federation
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Moscow, Russian Federation, 125167
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Novosibirsk, Russian Federation, 630091
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Sankt-Peterburg, Russian Federation, 197022
Singapore
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Singapore, Singapore, 119228
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Singapore, Singapore, 169608
Slovakia
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Bratislava, Slovak Republic, Slovakia, 833 10
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Bratislava, Slovakia, 851 07
South Africa
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Bloemfontein, South Africa, 901
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Cape Town, South Africa, 7925
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Parktown, South Africa, 2193
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Pretoria, South Africa, 0001
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Pretoria, South Africa, 0027
Spain
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Granada, Andalucia, Spain, 18014
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Malaga, Andalucia, Spain, 29010
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Santander, Cantabria, Spain, 39008
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Salamanca, Castilla y Leon, Spain, 37007
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Barcelona, Catalunya, Spain, 08036
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Barcelona, Catalunya, Spain, 08035
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Hospitalet de LLobregat, Catalunya, Spain, 08907
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Valencia, Comunidad Valenciana, Spain, 46010
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Valencia, Comunidad Valenciana, Spain, 46026
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La Coruna, Galicia, Spain, 15006
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Santiago de Compostela, Galicia, Spain, 15706
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La Laguna, Las Palmas de Gran Canaria, Spain, 38320
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Elche, Murcia, Spain, 03202
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Bilbao, Pais Vasco, Spain, 48013
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San Sebastian, Pais Vasco, Spain, 20014
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Madrid, Spain, 28006
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Madrid, Spain, 28046
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Madrid, Spain, 28034
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Madrid, Spain, 28041
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Zaragoza, Spain, 50009
Sweden
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Göteborg, Sweden, SE-413 45
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Huddinge, Sweden, SE-14186
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Luleå, Sweden, SE-971 80
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Lund, Sweden, SE-221 85
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Stockholm, Sweden, SE-171 76
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Sundsvall, Sweden, SE-851 86
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Umeå, Sweden, SE-901 85
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Uppsala, Sweden, SE-751 85
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Örebro, Sweden, SE-701 85
Switzerland
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Genève, Switzerland, 1211
Taiwan
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Lin-Ko, Taiwan, 33305
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Niaosong Township, Taiwan, 83301
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Taipei, Taiwan, 10002
Thailand
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Bangkok, Thailand, 10400
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Bangkok, Thailand, 10700
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Bangkok, Thailand, 10330
Turkey
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Adana, Turkey, 01330
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Ankara, Turkey, 06500
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Istanbul, Turkey, 34303
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Izmir, Turkey, 35340
United Kingdom
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Glasgow - Scotland, United Kingdom, G12 OYN
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Leeds, United Kingdom, LS9 7TF
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Liverpool, United Kingdom, L7 8XP
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London, United Kingdom, W12 0HS
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Nottingham, United Kingdom, NG5 1PB
Venezuela
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Caracas, Distrito Capital, Venezuela, 1010
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided by Novartis

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

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00471497     History of Changes
Other Study ID Numbers: CAMN107A2303, 2007-000208-34
Study First Received: May 7, 2007
Results First Received: April 10, 2013
Last Updated: November 19, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Austria: Ethikkommission
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: Ministry of Health
Canada: Health Canada
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Egypt: Ministry of Health and Population
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health
Hungary: Research Ethics Medical Committee
Italy: Ministry of Health
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Malaysia: Ministry of Health
Mexico: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Norway: Norwegian Medicines Agency
Poland: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
Slovakia: State Institute for Drug Control
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Swissmedic
Taiwan: Department of Health
Thailand: Food and Drug Administration
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Venezuela: Ministry of Health and Social Development

Keywords provided by Novartis:
leukemia
bone marrow
leukemia symptoms
lukemia
cml
complete blood count
lymphocyte
blood cancer
leukocytes
chronic leukemia
bone marrow biopsy
leukemia research
leukemia cells
bone marrow disease
chronic myeloid leukemia
blood cancer symptoms
white blood cell diseases
chronic myelogenous leukemia
leukemia treatment
leukemia facts
leucemia
facts about leukemia
myelogenous leukemia
newly diagnosed CML
newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP)

Additional relevant MeSH terms:
Abnormal Karyotype
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Philadelphia Chromosome
Bone Marrow Diseases
Chromosome Aberrations
Hematologic Diseases
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes
Translocation, Genetic
Imatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014