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Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome & /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase (`MACS1252)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01061177
First received: February 1, 2010
Last updated: January 4, 2017
Last verified: December 2016
  Purpose
This study will assess the efficacy and safety of nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive/BCR-ABL positive chronic myeloid leukaemia in chronic phase. The aim of the study is to confirm the rates of complete molecular remission (CMR) of nilotinib in newly diagnosed CML chronic phase patients in a pan-European population using the EUTOS standardized laboratories.

Condition Intervention Phase
CML in Chronic Phase
Drug: Nilotinib
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IIIb, Multicentre, Open-label Study of Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome and/or BCR-ABL Positive CML in Chronic Phase

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Percentage of Participants With Molecular Response (MR4^0) at 18 Months [ Time Frame: at 18 months ]
    MR4^0 was defined as either (i) detectable disease ≤ 0.01% BCR-ABL ratio (international scale (IS)) with mean ABL transcripts ≥ 10 000 or (ii) undetectable disease in complementary deoxyribonucleic acid (cDNA) with ≥ 10 000 ABL transcripts.


Secondary Outcome Measures:
  • Percentage of Participants Free From Progression to Accelerated Phase/Blast Crisis (AP/BC) at 12 and 24 Months [ Time Frame: at 12 and 24 months ]

    The following events were considered disease progression to AP/BC: Death due to disease under study; AP, as defined by any of the following: ≥ 15% blasts in the peripheral blood or bone marrow, but < 30% blasts in both the peripheral blood and bone marrow, ≥ 30% blasts plus promyelocytes in peripheral blood or bone marrow, ≥ 20% basophils in the peripheral blood, Thrombocytopenia (< 100 × 109/L) that was unrelated to therapy, Evidence of clonal evolution, as determined by medical review with consensus of the SSMC/DMC.

    BC was defined as: ≥ 30% blasts in peripheral blood or bone marrow, Appearance of extramedullary involvement other than hepatosplenomegaly proven by biopsy.


  • Rate of Event Free Survival at 12 and 24 Months [ Time Frame: at 12 and 24 months ]
    EFS was defined as the time from the date of Day 1 (first treatment) + 1 day to the first occurrence of any of the following: Loss of complete hematologic response (CHR), Loss of CCyR, Death from any cause, Progression to the AP or BC of CML, Not achieving CHR up to 3 months (ie, 91 + 15 days), Not achieving CCyR up to 18 months (ie, 548 + 15 days), whichever is earlier.

  • Percentage of Participants With Major Molecular Response (MMR) at, as Well as by, 12 and 24 Months [ Time Frame: 12 months, 24 months ]
    MMR was defined as BCR-ABL ratio (IS) ≤ 0.1% in a peripheral blood sample. BCR-ABL1 is an abnormal gene found in chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). The chromosomal defect in the Philadelphia chromosome is a translocation, in which parts of two chromosomes, 9 and 22, swap places. The result is that a fusion gene is created by juxtapositioning the Abl1 gene on chromosome 9 to a part of the BCR ("breakpoint cluster region") gene on chromosome 22. Depending upon the breakpoints on the BCR gene, there are several forms of fusion proteins.

  • Percentage of Participants With Complete Cytogenetic Response (CCyR) at, as Well as by, 12 and 24 Months [ Time Frame: 12 and 24 months ]
    CCyR parameters were defined as 0% Philadelphia positive (Ph+) metaphases. Loss of CCyR was defined as a patient exceeding the CCyR criteria (ie, > 0% Ph+ metaphases) at a subsequent visit after the patient had achieved CCyR.

  • Percentage of Participants With Major Cytogenetic Response (MCyR) at, as Well as by, 12 and 24 Months [ Time Frame: 12 and 24 months ]
    Major cytogenetic response (MCyR) parameters were defined as 0 to 35% Philadelphia positive (Ph+) metaphases.

  • Percentage of Participants Free From Progression to AP/BC With MR4^0 at 12 Months [ Time Frame: at 12 months ]

    The following events were considered disease progression to AP/BC: Death due to disease under study; AP, as defined by any of the following: ≥ 15% blasts in the peripheral blood or bone marrow, but < 30% blasts in both the peripheral blood and bone marrow, ≥ 30% blasts plus promyelocytes in peripheral blood or bone marrow, ≥ 20% basophils in the peripheral blood, Thrombocytopenia (< 100 × 109/L) that was unrelated to therapy, Evidence of clonal evolution, as determined by medical review with consensus of the SSMC/DMC.

    BC was defined as: ≥ 30% blasts in peripheral blood or bone marrow, Appearance of extramedullary involvement other than hepatosplenomegaly proven by biopsy.


  • Percentage of Participants With Event Free Survival in Participants Achieving MR4^0 at 12 Months [ Time Frame: at 12 months ]
    EFS was defined as the time from the date of Day 1 (first treatment) + 1 day to the first occurrence of any of the following: Loss of complete hematologic response (CHR), Loss of CCyR, Death from any cause, Progression to the AP or BC of CML, Not achieving CHR up to 3 months (i.e. 91 + 15 days).

  • Percentage of Participants With Progression Free Survival (PFS) at 12 and 24 Months [ Time Frame: 12 months, 24 months ]
    PFS was defined by the study protocol as the time from the date of start of study drug to the date of earliest progression to AP/BC, or the date of death from any cause.

  • Rate of Molecular Response (MR4^0) at, as Well as by, 12 and 24 Months [ Time Frame: 12 and 24 months ]
    MR4^0 was defined as either (i) detectable disease ≤ 0.01% BCR-ABL ratio (international scale (IS)) with mean ABL transcripts ≥ 10 000 or (ii) undetectable disease in complementary deoxyribonucleic acid (cDNA) with ≥ 10 000 ABL transcripts.

  • Rate of Molecular Response (MR4^5) at, as Well as by, 12 and 24 Months [ Time Frame: 12 and 24 months ]
    MR4^5 was defined as either (i) detectable disease ≤ 0.0032% BCR-ABL ratio (IS) with mean ABL transcripts ≥ 32 000 or (ii) undetectable disease in cDNA with ≥ 32 000 ABL transcripts).

  • Rate of Complete Hematologic Response (CHR) at, as Well as by, 12 and 24 Months [ Time Frame: 12 months, 24 months ]
    CHR was defined as all of the following present for ≥ 4 weeks in the peripheral blood: WBC count < 10 x 109/L, Platelet count < 450 x 109/L, No circulating peripheral blood blasts, promyelocytes, myelocytes, or metamyelocytes in the peripheral blood, The presence of < 5% basophils, No evidence of disease-related symptoms and extramedullary disease, including spleen and liver. Loss of CHR was defined as the appearance of any of the following after having achieved a CHR confirmed by a second determination ≥ 4 weeks later (unless associated with progression to AP/BC or death, which was considered to be a confirmed loss of CHR event on its own): WBC count that increased to > 20.0 x 109/L, Platelet count that increased to ≥ 600 x 109/L, Any palpable spleen, defined as size of spleen below costal margin > 5 cm, Appearance of > 5% myelocytes plus metamyelocytes, or any promyelocytes or blasts in the peripheral blood.

  • Percentage of Participants With Overall Survival at 12 and 24 Months [ Time Frame: 12 months, 24 months ]
    OS was defined as the time between the date of Day 1 (first treatment) and the date of death from any cause. Deaths which occurred after the 24-month time window and which were occasionally reported by some Investigators were excluded from the analysis. This is in agreement with the protocol stating that patients were to be followed for survival and progression to AP/BC up to 24 months after the participants treatment start.

  • Rate of Molecular Response (MR4^0) by 18 Months [ Time Frame: by 18 months ]

    MR4^0 was defined as either (i) detectable disease ≤ 0.01% BCR-ABL ratio (international scale (IS)) with mean ABL transcripts ≥ 10 000 or (ii) undetectable disease in complementary deoxyribonucleic acid (cDNA) with ≥ 10 000 ABL transcripts.

    BCR = Breakpoint Cluster Region gene/BCR gene product

    BCR-ABL is fusion gene formed from the ABL gene from chromosome 9 fusing with the BCR gene on chromosome 22, the gene product is BCR-ABL tyrosine kinase


  • Rate of Molecular Response (MR4^5) by 18 Months [ Time Frame: by 18 months ]

    MR4^5 was defined as either (i) detectable disease ≤ 0.0032% BCR-ABL ratio (IS) with mean ABL transcripts ≥ 32 000 or (ii) undetectable disease in cDNA with ≥ 32 000 ABL transcripts).

    BCR = Breakpoint Cluster Region gene/BCR gene product

    BCR-ABL is fusion gene formed from the ABL gene from chromosome 9 fusing with the BCR gene on chromosome 22, the gene product is BCR-ABL tyrosine kinase


  • Percentage of Participants With Progression Free Survival in Participants Achieving MR4^0 at 12 Months [ Time Frame: 12 months ]
    PFS was defined by the study protocol as the time from the date of start of study drug to the date of earliest progression to AP/BC, or the date of death from any cause.


Enrollment: 1090
Study Start Date: May 2010
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nilotinib
This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
Drug: Nilotinib
Nilotinib was supplied by Novartis as 150 mg hard gelatin capsules in bottles. Nilotinib was dosed on a flat scale and not dosed by body weight. This form of supply was continued for all participants entered into the core study.
Other Name: AMN107

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with diagnosis of CP-CML with cytogenetic confirmation of Philadelphia (Ph) chromosome
  • Ph negative cases or patients with variant translocations who are BCR-ABL positive in multiplex PCR are also eligible
  • WHO performance status 0-2
  • Laboratory assessments within normal limits
  • Written informed consent prior to any study procedures being performed

Exclusion Criteria:

  • Known impaired cardiac function
  • History of acute or chronic pancreatitis
  • Impaired gastrointestinal function or disease that may alter the absorption of study drug
  • Concomitant medications with potential QT prolongation, or known to interact with CYP450 isoenzymes (CYP3A4, CYP2C9, and CYP2C8)
  • Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
  • Patients who are pregnant or breast feeding, or females of reproductive potential not employing an effective method of birth control. Female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug

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: NCT01061177

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Locations
Austria
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Graz, Austria, 8036
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Innsbruck, Austria, A-6020
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Linz, Austria, 4010
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Rankweil, Austria, A-6830
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Salzburg, Austria, 5020
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Vienna, Austria, A-1130
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Wels, Austria, A-4600
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Wien, Austria, A-1140
Belgium
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Aalst, Belgium, 9300
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Brugge, Belgium, 8000
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Brussels, Belgium, BE-B-1200
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Brussel, Belgium, 1090
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Bruxelles, Belgium, 1000
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Bruxelles, Belgium, 1070
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Charleroi, Belgium, 6000
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Edegem, Belgium, 2650
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Gent, Belgium, 9000
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Hasselt, Belgium, 3500
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Laeken, Belgium, 1020
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Leuven, Belgium, 3000
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Luxembourg, Belgium, 1210
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Roeselare, Belgium, 8800
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Verviers, Belgium, 4800
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Yvoir, Belgium, 5530
Bulgaria
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Pleven, Bulgaria, 5800
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Plovdiv, Bulgaria, 4002
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Sofia, Bulgaria, 1431
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Sofia, Bulgaria, 1756
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Varna, Bulgaria, 9000
Croatia
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Rijeka, Croatia, 51000
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Zagreb, Croatia, 10000
Czech Republic
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Olomouc, CZE, Czech Republic, 775 20
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Brno - Bohunice, Czech Republic, 625 00
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Hradec Kralove, Czech Republic, 500 05
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Praha 2, Czech Republic, 128 20
Denmark
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Aarhus C, Denmark, DK-8000
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Copenhagen, Denmark, DK-2100
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Odense C, Denmark, DK-5000
Estonia
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Tartu, Estonia, 51006
Finland
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HUS Helsinki, Finland, FIN-00029
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Oulu, Finland, 900114
France
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Bayonne, Bayonne cedex, France, 64109
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Paris Cedex 10, Cedex 10, France, 75475
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Saint Denis, FRANCE / La Reunion, France, 97405
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Monte-Carlo, Principauté de Monaco, France, 98012
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Aix en Provence Cedex 1, France, 13616
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Amiens cedex1, France, 80054
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Angers Cedex 1, France, 49033
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Argenteuil Cedex, France, 95107
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Avignon cedex 9, France, 84902
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Besancon cedex, France, 25030
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Blois Cedex, France, 41016
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Bordeaux, France, 33076
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Brest, France, 29200
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Caen, France, 14000
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Chalon sur Saône, France, 71321
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Chambéry cedex, France, 73011
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Clermont-Ferrand cedex 1, France, 63003
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Compiègne cedex, France, 60321
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Corbeil Essonnes, France, 91100
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Creteil, France, 94010
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Dijon, France, 21034
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Dunkerque, France, 59240
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Grenoble, France, 38043
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La Roche sur Yon cedex 9, France, 85925
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Le Chesnay, France, 78157
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Le Coudray, France, 28630
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Le Mans Cedex 09, France, 72037
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Lens Cedex, France, 62307
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Lille cedex, France, 59020
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Limoges cedex, France, 87042
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Marseille cedex 20, France, 13915
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Marseille, France, 13273
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Metz Cedex 01, France, 57038
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Montfermeil, France, 93370
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Montpellier cedex 5, France, 34295
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Mulhouse cedex, France, 68070
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Mâcon Cedex, France, 71018
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Nantes, France, 44035
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Nice Cedex 2, France, 06189
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Nimes, France, 32900
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Paris, France, 75012
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Pau, France, 64000
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Perpignan, France, 66046
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Pringy cedex, France, 74374
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Reims, France, 51092
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Rennes, France, 35019
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Roubaix, France, 59100
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Rouen Cedex 1, France, 76038
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Saint Brieuc cedex 1, France, 22027
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Saint Priest en Jarez Cedex, France, 42271
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St Quentin Cedex, France, 02321
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Strasbourg cedex, France, 67085
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Strasbourg cedex, France, 67091
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Toulouse Cedex 9, France, 31059
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Tours Cedex 9, France, 37044
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Troyes, France, 10003
Germany
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Koeln, Nordrhein-Westfalen, Germany, 50937
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Aachen, Germany, 52074
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Aschaffenburg, Germany, 63739
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Augsburg, Germany, 86156
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Bamberg, Germany, 96049
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Bayreuth, Germany, 95445
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Berlin, Germany, 10707
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Berlin, Germany, 10709
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Berlin, Germany, 13353
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Berlin, Germany, 14195
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Bielefeld, Germany, 33604
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Bonn, Germany, 53105
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Bottrop, Germany, 46236
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Bremen, Germany, 28177
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Dresden, Germany, 01307
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Duesseldorf, Germany, 40225
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Duisburg, Germany, 47166
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Eisenach, Germany, 99817
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Eschweiler, Germany, 52249
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Essen, Germany, 45136
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Essen, Germany, 45147
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Frankfurt, Oder, Germany, 15236
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Frankfurt, Germany, 60590
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Frankfurt, Germany, 60596
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Freiburg, Germany, 79106
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Fulda, Germany, 36043
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Giessen, Germany, 35392
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Goslar, Germany, 38642
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Greifswald, Germany, 17475
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Hagen, Germany, 58097
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Hamburg, Germany, 20246
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Hamm, Germany, 59063
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Hannover, Germany, 30170
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Hannover, Germany, 30625
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Herrsching, Germany, 82211
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Hildesheim, Germany, 31134
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Jena, Germany, 07740
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Karlsruhe, Germany, 76133
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Karlsruhe, Germany, 76135
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Kassel, Germany, 34119
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Kassel, Germany, 34125
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Kiel, Germany, 24116
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Koblenz, Germany, 56068
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Landshut, Germany, 84028
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Leipzig, Germany, 04103
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Lemgo, Germany, 32657
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Luebeck, Germany, 23563
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Magdeburg, Germany, 39104
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Mainz, Germany, 55131
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Mannheim, Germany, 68169
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Marburg, Germany, 35039
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Moers, Germany, 47441
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Muelheim, Germany, 45468
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Muenchen, Germany, 80335
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Muenchen, Germany, 81241
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Muenchen, Germany, 81737
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Muenster, Germany, 48149
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Mutlangen, Germany, 73557
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Mönchengladbach, Germany, 41063
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München, Germany, 81675
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Neunkirchen, Germany, 66538
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Nuernberg, Germany, 90419
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Nuernberg, Germany, 90449
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Offenburg, Germany, 77652
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Paderborn, Germany, 33102
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Ravensburg, Germany, 88214
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Rostock, Germany, 18057
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Schorndorf, Germany, 73614
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Schwäbisch-Hall, Germany, 74523
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Sindelfingen, Germany, 71065
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Stuttgart, Germany, 70376
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Traunstein, Germany, 83278
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Triberg, Germany, 78098
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Ulm, Germany, 89081
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Velbert, Germany, 42551
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Viersen, Germany, 45468
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Weilheim, Germany, 82362
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Wendlingen, Germany, 73240
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Wuerzburg, Germany, 97080
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Würzburg, Germany, 97080
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Zella-Mehlis, Germany, 98544
Greece
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Alexandroupolis, Evros, Greece, 68100
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Athens, GR, Greece, 115 27
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Larissa, GR, Greece, 411 10
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Thessaloniki, GR, Greece, 546 42
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Athens, Greece, 11527
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Heraklion Crete, Greece, 711 10
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Patras, Greece, 265 00
Hungary
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Budapest, Hungary, 1097
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Debrecen, Hungary, 4032
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Kaposvar, Hungary, 7400
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Pecs, Hungary, 7624
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Szeged, Hungary, H-6725
Italy
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Ancona, AN, Italy, 60126
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Avellino, AV, Italy, 83100
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Bari, BA, Italy, 70124
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Bologna, BO, Italy, 40138
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Brindisi, BR, Italy, 72100
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Brescia, BS, Italy, 25123
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Cagliari, CA, Italy, 09121
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Cagliari, CA, Italy, 09126
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Cuneo, CN, Italy, 12100
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Rossano, CS, Italy, 87067
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Catanzaro, CZ, Italy, 88100
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Cona, FE, Italy, 44100
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San Giovanni Rotondo, FG, Italy, 71013
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Firenze, FI, Italy, 50134
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Genova, GE, Italy, 16132
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Roma, Lazio, Italy, 00168
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Lecce, LE, Italy, 73100
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Livorno, LI, Italy, 57124
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Milano, MI, Italy, 20122
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Milano, MI, Italy, 20162
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Modena, MO, Italy, 41100
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Nuoro, NU, Italy, 08100
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Palermo, PA, Italy, 90146
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Padova, PD, Italy, 35128
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Pescara, PE, Italy, 65124
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Pisa, PI, Italy, 56126
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Pesaro, PU, Italy, 61100
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Pavia, PV, Italy, 27100
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Potenza, PZ, Italy, 85100
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Ravenna, RA, Italy, 48100
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Reggio Calabria, RC, Italy, 89124
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Reggio Emilia, RE, Italy, 42123
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Roma, RM, Italy, 00144
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Roma, RM, Italy, 00161
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Nocera Inferiore, SA, Italy, 84014
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Siena, SI, Italy, 53100
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Sassari, SS, Italy, 07100
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Taranto, TA, Italy, 74100
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Orbassano, TO, Italy, 10043
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Torino, TO, Italy, 10126
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Terni, TR, Italy, 05100
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Treviso, TV, Italy, 31100
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Ronciglione, VT, Italy, 01100
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Napoli, Italy, 80131
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Napoli, Italy, 80132
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Novara, Italy, 28100
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Perugia, Italy, 06129
Latvia
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Riga, LV, Latvia, 1006
Lithuania
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Kaunas, Lithuania, 3007
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Klaipeda, Lithuania, LT-92231
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Vilnius, Lithuania, LT-08661
Netherlands
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Amsterdam, Netherlands, 1081 HV
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Delft, Netherlands, 2625 AD
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Enschede, Netherlands, 7513 ER
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Groningen, Netherlands, 9713 GZ
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Nijmegen, Netherlands, 6525 GA
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Rotterdam, Netherlands, 3075 EA
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Zwolle, Netherlands, 8025 AB
Norway
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Bergen, Norway, NO-5021
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Oslo, Norway, NO-0310
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Stavanger, Norway, 4068
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Tromsoe, Norway, NO-9038
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Trondheim, Norway, 7006
Poland
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Gdansk, Poland, 80-952
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Krakow, Poland, 30-510
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Lublin, Poland, 20-081
Novartis Investigative Site
Warsaw, Poland, 02-106
Novartis Investigative Site
Warszawa, Poland, 02-776
Novartis Investigative Site
Wroclaw, Poland, 50-367
Portugal
Novartis Investigative Site
Lisboa, Portugal, 1150-314
Novartis Investigative Site
Porto, Portugal, 4200-072
Novartis Investigative Site
Porto, Portugal, 4200319
Romania
Novartis Investigative Site
Bucharest, District 2, Romania, 022328
Novartis Investigative Site
Iasi, Jud. Iasi, Romania, 700111
Novartis Investigative Site
Bucharest, Romania, 030171
Novartis Investigative Site
Bucharest, Romania, 050098
Novartis Investigative Site
Cluj-Napoca, Romania, 3400
Novartis Investigative Site
Timisoara, Romania, 300 079
Slovakia
Novartis Investigative Site
Kosice, Slovak Republic, Slovakia, 04066
Novartis Investigative Site
Bratislava, Slovakia, 851 07
Novartis Investigative Site
Martin, Slovakia, 03601
Slovenia
Novartis Investigative Site
Celje, Slovenia, 3000
Novartis Investigative Site
Ljubljana, Slovenia, 1000
Spain
Novartis Investigative Site
Elche, Alicante, Spain, 03203
Novartis Investigative Site
Oviedo, Asturias, Spain, 33006
Novartis Investigative Site
Santander, Cantabria, Spain, 39008
Novartis Investigative Site
Toledo, Castilla la Mancha, Spain, 45071
Novartis Investigative Site
Salamanca, Castilla y Leon, Spain, 37007
Novartis Investigative Site
Badalona, Catalunya, Spain, 08916
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08003
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08036
Novartis Investigative Site
Tarragona, Catalunya, Spain, 43005
Novartis Investigative Site
Terrassa, Catalunya, Spain, 08221
Novartis Investigative Site
Valencia, Comunidad Valenciana, Spain, 46010
Novartis Investigative Site
La Coruna, Galicia, Spain, 15006
Novartis Investigative Site
Orense, Galicia, Spain, 32005
Novartis Investigative Site
Las Palmas de Gran Canaria, Las Palmas de G.C, Spain, 35010
Novartis Investigative Site
Majadahonda, Madrid, Spain, 28222
Novartis Investigative Site
Pamplona, Navarra, Spain, 31008
Novartis Investigative Site
Bilbao, Pais Vasco, Spain, 48013
Novartis Investigative Site
San Sebastian, Pais Vasco, Spain, 20080
Novartis Investigative Site
La Laguna, Santa Cruz de Tenerife, Spain, 38320
Novartis Investigative Site
Baracaldo, Vizcaya, Spain, 48903
Novartis Investigative Site
Barcelona, Spain, 08041
Novartis Investigative Site
Madrid, Spain, 28006
Novartis Investigative Site
Madrid, Spain, 28034
Novartis Investigative Site
Madrid, Spain, 28040
Novartis Investigative Site
Madrid, Spain, 28041
Novartis Investigative Site
Madrid, Spain, 28046
Novartis Investigative Site
Murcia, Spain, 30008
Novartis Investigative Site
Zaragoza, Spain, 50009
Sweden
Novartis Investigative Site
Göteborg, Sweden, SE-413 45
Novartis Investigative Site
Huddinge, Sweden, SE-14186
Novartis Investigative Site
Linköping, Sweden, SE-581 85
Novartis Investigative Site
Lulea, Sweden, SE-971 80
Novartis Investigative Site
Lund, Sweden, SE-221 85
Novartis Investigative Site
Stockholm, Sweden, SE-171 76
Novartis Investigative Site
Umeå, Sweden, SE-901 85
Novartis Investigative Site
Uppsala, Sweden, SE-751 85
Switzerland
Novartis Investigative Site
Bern, Switzerland, 3010
Novartis Investigative Site
Chur, Switzerland, 7000
Novartis Investigative Site
Genève, Switzerland, 1211
Novartis Investigative Site
Zurich, Switzerland, 8091
United Kingdom
Novartis Investigative Site
Uxbridge, London, United Kingdom, UB8 3NN
Novartis Investigative Site
Cardiff, United Kingdom, CF14 4XW
Novartis Investigative Site
Dudley, United Kingdom, DY1 2HQ
Novartis Investigative Site
London, United Kingdom, SE5 9RS
Novartis Investigative Site
London, United Kingdom, W12 0HS
Novartis Investigative Site
Nottingham, United Kingdom, NG5
Novartis Investigative Site
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01061177     History of Changes
Other Study ID Numbers: CAMN107EIC01
2009-017775-19 ( EudraCT Number )
Study First Received: February 1, 2010
Results First Received: August 3, 2015
Last Updated: January 4, 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Leukemia
myeloid
myelogenous
chronic BCR-ABL positive
Nilotinib
Philadelphia chromosome
CML in chronic phase

Additional relevant MeSH terms:
Philadelphia Chromosome
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes

ClinicalTrials.gov processed this record on May 25, 2017