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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01061177
First received: February 1, 2010
Last updated: January 12, 2014
Last verified: January 2014
  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
Leukemia, Myeloid
Drug: Nilotinib
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:

Primary Outcome Measures:
  • Rate of complete molecular response (CMR). Levels of BCR-ABL transcripts will be determined by RQ-PCR testing of peripheral blood and analysed at an appropriate national EUTOS reference laboratory. [ Time Frame: after 18 months of study drug ] [ Designated as safety issue: No ]
    CMR is defined as undetectable BCR-ABL transcripts by quantitative RT-PCR in a peripheral blood sample of at least 10 ml with a minimum sensitivity of 1:10,000.


Secondary Outcome Measures:
  • Rate of early progression to accelerated phase and blast crisis in year 1 and 2 and the rate of events in patients achieving a CMR at 1 year [ Time Frame: at 12 and 24 months ] [ Designated as safety issue: No ]
  • The rate of MMR at, as well as by, 12 and 24 months; the rate of CCyR at, as well as by , 12 and 24 months; the rate of CHR at, as well as by, 12 and 24 months [ Time Frame: at as welll as by 12 and 24 months ] [ Designated as safety issue: No ]
  • The rate of early events, event free survival, overall survival; and safety and tolerability of nilotinib [ Time Frame: at 12 and 24 months ] [ Designated as safety issue: No ]
  • Exploratory endpoints patterns [ Time Frame: at, as well as, by 3, 6, 9, 12, 15, 21, and 24 months ] [ Designated as safety issue: No ]
    Exploratory endpoints include the kinetics of MMR and the dynamics of molecular response and potential patterns


Estimated Enrollment: 936
Study Start Date: May 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nilotinib Drug: Nilotinib
Other Name: AMN107

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  1. Known impaired cardiac function
  2. History of acute or chronic pancreatitis
  3. Impaired gastrointestinal function or disease that may alter the absorption of study drug
  4. Concomitant medications with potential QT prolongation, or known to interact with CYP450 isoenzymes (CYP3A4, CYP2C9, and CYP2C8)
  5. Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
  6. 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

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

  Hide Study Locations
Locations
Austria
Novartis Investigative Site Recruiting
Graz, Austria, 8036
Novartis Investigative Site Completed
Innsbruck, Austria, A-6020
Novartis Investigative Site Withdrawn
Klagenfurt, Austria, A-9026
Novartis Investigative Site Recruiting
Linz, Austria, 4010
Novartis Investigative Site Active, not recruiting
Rankweil, Austria, A-6830
Novartis Investigative Site Recruiting
Salzburg, Austria, 5020
Novartis Investigative Site Completed
Vienna, Austria, A-1130
Novartis Investigative Site Completed
Wels, Austria, A-4600
Novartis Investigative Site Recruiting
Wien, Austria, A-1140
Belgium
Novartis Investigative Site Withdrawn
Aalst, Belgium, 9300
Novartis Investigative Site Completed
Aalst, Belgium, 9300
Novartis Investigative Site Withdrawn
Antwerp, Belgium, 2020
Novartis Investigative Site Active, not recruiting
Brugge, Belgium, 8000
Novartis Investigative Site Active, not recruiting
Brussels, Belgium, BE-B-1200
Novartis Investigative Site Completed
Bruxelles, Belgium, 1070
Novartis Investigative Site Active, not recruiting
Bruxelles, Belgium, 1000
Novartis Investigative Site Completed
Charleroi, Belgium, 6000
Novartis Investigative Site Active, not recruiting
Edegem, Belgium, 2650
Novartis Investigative Site Completed
Gent, Belgium, 9000
Novartis Investigative Site Active, not recruiting
Godinne, Belgium, 5530
Novartis Investigative Site Withdrawn
Godinne, Belgium, 5530
Novartis Investigative Site Withdrawn
Haine-saint-Paul, Belgium, 7100
Novartis Investigative Site Active, not recruiting
Hasselt, Belgium, 3500
Novartis Investigative Site Completed
Jette, Belgium, 1090
Novartis Investigative Site Completed
Laeken, Belgium, 1020
Novartis Investigative Site Active, not recruiting
Leuven, Belgium, 3000
Novartis Investigative Site Withdrawn
Liege, Belgium, 4000
Novartis Investigative Site Completed
Luxembourg, Belgium, 1210
Novartis Investigative Site Withdrawn
Montigny-Le Tilleul, Belgium, 6110
Novartis Investigative Site Completed
Roeselare, Belgium, 8800
Novartis Investigative Site Completed
Verviers, Belgium, 4800
Czech Republic
Novartis Investigative Site Completed
Olomouc, CZE, Czech Republic, 775 20
Novartis Investigative Site Completed
Brno - Bohunice, Czech Republic, 625 00
Novartis Investigative Site Active, not recruiting
Hradec Kralove, Czech Republic, 500 05
Novartis Investigative Site Active, not recruiting
Praha 2, Czech Republic, 128 20
Denmark
Novartis Investigative Site Completed
Aarhus C, Denmark, DK-8000
Novartis Investigative Site Completed
Copenhagen, Denmark, DK-2100
Novartis Investigative Site Withdrawn
Herlev, Denmark, DK-2730
Novartis Investigative Site Completed
Odense C, Denmark, DK-5000
Novartis Investigative Site Withdrawn
Ålborg, Denmark, DK-9100
Finland
Novartis Investigative Site Completed
HUS Helsinki, Finland, FIN-00029
Novartis Investigative Site Terminated
Oulu, Finland, 900114
Novartis Investigative Site Completed
Turku, Finland, FIN-20521
France
Novartis Investigative Site Completed
Saint Denis, FRANCE / La Reunion, France, 97405
Novartis Investigative Site Terminated
Monte-Carlo, Principauté de Monaco, France, 98012
Novartis Investigative Site Terminated
Aix en Provence Cedex 1, France, 13616
Novartis Investigative Site Completed
Amiens cedex1, France, 80054
Novartis Investigative Site Terminated
Angers Cedex 1, France, 49033
Novartis Investigative Site Completed
Argenteuil Cedex, France, 95107
Novartis Investigative Site Completed
Avignon cedex 9, France, 84902
Novartis Investigative Site Completed
Bayonne, France, 64109
Novartis Investigative Site Completed
Besancon cedex, France, 25030
Novartis Investigative Site Active, not recruiting
Blois Cedex, France, 41016
Novartis Investigative Site Completed
Bordeaux, France, 33076
Novartis Investigative Site Withdrawn
Bourges cedex, France, 18020
Novartis Investigative Site Completed
Brest, France, 29200
Novartis Investigative Site Terminated
Caen, France, 14000
Novartis Investigative Site Completed
Chalon sur Saône, France, 71321
Novartis Investigative Site Completed
Chambéry cedex, France, 73011
Novartis Investigative Site Withdrawn
Clamart, France, 92141
Novartis Investigative Site Completed
Clermont-Ferrand cedex 1, France, 63003
Novartis Investigative Site Terminated
Compiègne cedex, France, 60321
Novartis Investigative Site Completed
Corbeil Essonnes, France, 91100
Novartis Investigative Site Completed
Creteil, France, 94010
Novartis Investigative Site Completed
Dijon, France, 21034
Novartis Investigative Site Completed
Dunkerque, France, 59240
Novartis Investigative Site Completed
Grenoble, France, 38043
Novartis Investigative Site Completed
La Roche sur Yon cedex 9, France, 85925
Novartis Investigative Site Completed
Le Chesnay, France, 78157
Novartis Investigative Site Completed
Le Coudray, France, 28630
Novartis Investigative Site Terminated
Le Mans Cedex 09, France, 72037
Novartis Investigative Site Completed
Lens Cedex, France, 62307
Novartis Investigative Site Completed
Lille cedex, France, 59020
Novartis Investigative Site Completed
Limoges cedex, France, 87042
Novartis Investigative Site Completed
Marseille, France, 13273
Novartis Investigative Site Completed
Marseille cedex 20, France, 13915
Novartis Investigative Site Withdrawn
Meaux cedex, France, 77104
Novartis Investigative Site Terminated
Metz Cedex 01, France, 57038
Novartis Investigative Site Completed
Montfermeil, France, 93370
Novartis Investigative Site Completed
Montpellier cedex 5, France, 34295
Novartis Investigative Site Completed
Mulhouse cedex, France, 68070
Novartis Investigative Site Completed
Mâcon Cedex, France, 71018
Novartis Investigative Site Completed
Nantes, France, 44035
Novartis Investigative Site Withdrawn
Nice Cedex, France, 06202
Novartis Investigative Site Completed
Nice Cedex 2, France, 06189
Novartis Investigative Site Completed
Nimes, France, 32900
Novartis Investigative Site Completed
Paris, France, 75475
Novartis Investigative Site Completed
Paris, France, 75012
Novartis Investigative Site Withdrawn
Paris, France, 75015
Novartis Investigative Site Terminated
Pau, France, 64000
Novartis Investigative Site Terminated
Perpignan, France, 66046
Novartis Investigative Site Withdrawn
Pierre-Benite Cedex, France, 69495
Novartis Investigative Site Completed
Pringy cedex, France, 74374
Novartis Investigative Site Completed
Reims, France, 51092
Novartis Investigative Site Terminated
Rennes, France, 35019
Novartis Investigative Site Completed
Roubaix, France, 59100
Novartis Investigative Site Completed
Rouen Cedex 1, France, 76038
Novartis Investigative Site Terminated
Saint Brieuc cedex 1, France, 22027
Novartis Investigative Site Completed
Saint Priest en Jarez Cedex, France, 42271
Novartis Investigative Site Completed
St Quentin Cedex, France, 02321
Novartis Investigative Site Completed
Strasbourg cedex, France, 67091
Novartis Investigative Site Completed
Strasbourg cedex, France, 67085
Novartis Investigative Site Completed
Toulouse cedex 9, France, 31059
Novartis Investigative Site Completed
Tours Cedex 9, France, 37044
Novartis Investigative Site Completed
Troyes, France, 10003
Novartis Investigative Site Withdrawn
Vandoeuvre les Nancy, France, 54511
Germany
Novartis Investigative Site Active, not recruiting
Aachen, Germany, 52074
Novartis Investigative Site Active, not recruiting
Aschaffenburg, Germany, 63739
Novartis Investigative Site Completed
Augsburg, Germany, 86156
Novartis Investigative Site Active, not recruiting
Bamberg, Germany, 96049
Novartis Investigative Site Active, not recruiting
Bayreuth, Germany, 95445
Novartis Investigative Site Completed
Berlin, Germany, 13353
Novartis Investigative Site Completed
Berlin, Germany, 10707
Novartis Investigative Site Completed
Berlin, Germany, 14195
Novartis Investigative Site Completed
Berlin, Germany, 10709
Novartis Investigative Site Withdrawn
Bielefeld, Germany, 33611
Novartis Investigative Site Active, not recruiting
Bielefeld, Germany, 33604
Novartis Investigative Site Active, not recruiting
Bonn, Germany, 53105
Novartis Investigative Site Active, not recruiting
Bottrop, Germany, 46236
Novartis Investigative Site Completed
Bremen, Germany, 28177
Novartis Investigative Site Withdrawn
Cottbus, Germany, 03046
Novartis Investigative Site Withdrawn
Detmold, Germany, 32756
Novartis Investigative Site Withdrawn
Donauwoerth, Germany, 86609
Novartis Investigative Site Completed
Dresden, Germany, 01307
Novartis Investigative Site Withdrawn
Dresden, Germany, 01307
Novartis Investigative Site Active, not recruiting
Dresden, Germany, 01307
Novartis Investigative Site Completed
Duesseldorf, Germany, 40225
Novartis Investigative Site Completed
Duisburg, Germany, 47166
Novartis Investigative Site Active, not recruiting
Eisenach, Germany, 99817
Novartis Investigative Site Withdrawn
Erlangen, Germany, 91054
Novartis Investigative Site Active, not recruiting
Eschweiler, Germany, D-52249
Novartis Investigative Site Completed
Essen, Germany, 45147
Novartis Investigative Site Completed
Essen, Germany, 45136
Novartis Investigative Site Active, not recruiting
Frankfurt, Germany, 60596
Novartis Investigative Site Active, not recruiting
Frankfurt, Germany, 60590
Novartis Investigative Site Completed
Frankfurt, Oder, Germany, 15236
Novartis Investigative Site Active, not recruiting
Freiburg, Germany, 79106
Novartis Investigative Site Completed
Fulda, Germany, 36043
Novartis Investigative Site Withdrawn
Garmisch-Partenkirchen, Germany, 82467
Novartis Investigative Site Withdrawn
Gerlingen, Germany, 70839
Novartis Investigative Site Withdrawn
Germering, Germany, 82110
Novartis Investigative Site Completed
Giessen, Germany, 35392
Novartis Investigative Site Withdrawn
Goettingen, Germany, 37073
Novartis Investigative Site Active, not recruiting
Goslar, Germany, 38642
Novartis Investigative Site Completed
Greifswald, Germany, 17475
Novartis Investigative Site Withdrawn
Groitzsch, Germany, 04539
Novartis Investigative Site Withdrawn
Göttingen, Germany, D-37075
Novartis Investigative Site Withdrawn
Gütersloh, Germany, 33332
Novartis Investigative Site Completed
Hagen, Germany, 58097
Novartis Investigative Site Withdrawn
Halberstadt, Germany, 38820
Novartis Investigative Site Withdrawn
Halle, Germany, 06110
Novartis Investigative Site Withdrawn
Hamburg, Germany, 22767
Novartis Investigative Site Active, not recruiting
Hamburg, Germany, 20246
Novartis Investigative Site Withdrawn
Hamburg, Germany, 20095
Novartis Investigative Site Active, not recruiting
Hamm, Germany, 59063
Novartis Investigative Site Completed
Hannover, Germany, 30625
Novartis Investigative Site Active, not recruiting
Hannover, Germany, 30170
Novartis Investigative Site Active, not recruiting
Herrsching, Germany, 82211
Novartis Investigative Site Active, not recruiting
Hildesheim, Germany, 31134
Novartis Investigative Site Withdrawn
Homburg, Germany, 66421
Novartis Investigative Site Withdrawn
Jena, Germany, 07743
Novartis Investigative Site Active, not recruiting
Jena, Germany, 07740
Novartis Investigative Site Active, not recruiting
Karlsruhe, Germany, 76135
Novartis Investigative Site Terminated
Karlsruhe, Germany, 76133
Novartis Investigative Site Active, not recruiting
Kassel, Germany, 34125
Novartis Investigative Site Completed
Kassel, Germany, 34119
Novartis Investigative Site Withdrawn
Kempten, Germany, 87439
Novartis Investigative Site Active, not recruiting
Kiel, Germany, D-24116
Novartis Investigative Site Completed
Koblenz, Germany, 56068
Novartis Investigative Site Withdrawn
Kronach, Germany, 96317
Novartis Investigative Site Active, not recruiting
Köln, Germany, 50924
Novartis Investigative Site Active, not recruiting
Landshut, Germany, 84028
Novartis Investigative Site Withdrawn
Leipzig, Germany, 04129
Novartis Investigative Site Active, not recruiting
Leipzig, Germany, 04103
Novartis Investigative Site Completed
Lemgo, Germany, 32657
Novartis Investigative Site Withdrawn
Leverkusen, Germany, 51375
Novartis Investigative Site Withdrawn
Loerrach, Germany, 79539
Novartis Investigative Site Active, not recruiting
Luebeck, Germany, 23563
Novartis Investigative Site Completed
Magdeburg, Germany, 39104
Novartis Investigative Site Completed
Mainz, Germany, D-55101
Novartis Investigative Site Active, not recruiting
Mannheim, Germany, 68169
Novartis Investigative Site Completed
Marburg, Germany, 35039
Novartis Investigative Site Withdrawn
Marburg, Germany, 35039
Novartis Investigative Site Active, not recruiting
Moers, Germany, 47441
Novartis Investigative Site Completed
Muelheim, Germany, 45468
Novartis Investigative Site Withdrawn
Muenchen, Germany, 80637
Novartis Investigative Site Completed
Muenchen, Germany, 81737
Novartis Investigative Site Withdrawn
Muenchen, Germany, 81679
Novartis Investigative Site Completed
Muenchen, Germany, 81241
Novartis Investigative Site Active, not recruiting
Muenchen, Germany, 80335
Novartis Investigative Site Active, not recruiting
Muenster, Germany, 48149
Novartis Investigative Site Active, not recruiting
Mutlangen, Germany, 73557
Novartis Investigative Site Completed
Mönchengladbach, Germany, 41063
Novartis Investigative Site Completed
München, Germany, 81675
Novartis Investigative Site Active, not recruiting
Neunkirchen, Germany, 66538
Novartis Investigative Site Withdrawn
Northeim, Germany, 37154
Novartis Investigative Site Active, not recruiting
Nuernberg, Germany, 90449
Novartis Investigative Site Active, not recruiting
Nuernberg, Germany, 90419
Novartis Investigative Site Active, not recruiting
Offenburg, Germany, 77652
Novartis Investigative Site Completed
Paderborn, Germany, 33102
Novartis Investigative Site Withdrawn
Passau, Germany, 94036
Novartis Investigative Site Withdrawn
Pinneberg, Germany, 25421
Novartis Investigative Site Completed
Pluederhausen, Germany, 73655
Novartis Investigative Site Completed
Ravensburg, Germany, 88214
Novartis Investigative Site Withdrawn
Regensburg, Germany, 93053
Novartis Investigative Site Withdrawn
Rehling, Germany, 86508
Novartis Investigative Site Active, not recruiting
Rostock, Germany, 18057
Novartis Investigative Site Withdrawn
Rotenburg, Germany, 27356
Novartis Investigative Site Completed
Schwäbisch-Hall, Germany, 74523
Novartis Investigative Site Completed
Sindelfingen, Germany, 71065
Novartis Investigative Site Withdrawn
Sonneberg, Germany, 96515
Novartis Investigative Site Completed
Stuttgart, Germany, 70376
Novartis Investigative Site Withdrawn
Stuttgart, Germany, 70199
Novartis Investigative Site Terminated
Traunstein, Germany, 83278
Novartis Investigative Site Completed
Triberg, Germany, 78098
Novartis Investigative Site Active, not recruiting
Ulm, Germany, 89081
Novartis Investigative Site Active, not recruiting
Velbert, Germany, 42551
Novartis Investigative Site Active, not recruiting
Viersen, Germany, 45468
Novartis Investigative Site Withdrawn
Villingen, Germany, 78050
Novartis Investigative Site Withdrawn
Villingen-Schwenningen, Germany, 78050
Novartis Investigative Site Withdrawn
Waiblingen, Germany, 71334
Novartis Investigative Site Withdrawn
Weiden, Germany, 92637
Novartis Investigative Site Completed
Weilheim, Germany, 82362
Novartis Investigative Site Completed
Wendlingen, Germany, 73240
Novartis Investigative Site Active, not recruiting
Wuerzburg, Germany, 97070
Novartis Investigative Site Active, not recruiting
Würzburg, Germany, 97080
Novartis Investigative Site Completed
Zella-Mehlis, Germany, 98544
Greece
Novartis Investigative Site Completed
Heraklion Crete, Crete, Greece, GR-71110
Novartis Investigative Site Recruiting
Alexandroupolis, Greece, GR 68100
Novartis Investigative Site Withdrawn
Athens, Greece, GR 12461
Novartis Investigative Site Completed
Athens, Greece, GR 11527
Novartis Investigative Site Withdrawn
Athens - GR, Greece, 10676
Novartis Investigative Site Completed
Larissa, Greece, 41110
Novartis Investigative Site Active, not recruiting
Patras, Greece, 26500
Novartis Investigative Site Withdrawn
Pireas, Greece, 18537
Novartis Investigative Site Withdrawn
Thessaloniki, Greece, GR 54635
Novartis Investigative Site Withdrawn
Thessaloniki, Greece, GR 570 10
Novartis Investigative Site Withdrawn
Thessaloniki, Greece, GR 540 07
Novartis Investigative Site Recruiting
Thessaloniki, Greece, GR 546 39
Hungary
Novartis Investigative Site Active, not recruiting
Budapest, Hungary, 1097
Novartis Investigative Site Active, not recruiting
Debrecen, Hungary, 4032
Novartis Investigative Site Active, not recruiting
Kaposvár, Hungary, 7400
Novartis Investigative Site Active, not recruiting
Pecs, Hungary, 7624
Novartis Investigative Site Active, not recruiting
Szeged, Hungary, H-6720
Italy
Novartis Investigative Site Withdrawn
Alessandria, AL, Italy, 15100
Novartis Investigative Site Completed
Ancona, AN, Italy, 60126
Novartis Investigative Site Completed
Avellino, AV, Italy, 83100
Novartis Investigative Site Completed
Bari, BA, Italy, 70124
Novartis Investigative Site Completed
Bologna, BO, Italy, 40138
Novartis Investigative Site Completed
Brindisi, BR, Italy, 72100
Novartis Investigative Site Withdrawn
Brescia, BS, Italy, 25123
Novartis Investigative Site Completed
Brescia, BS, Italy, 25123
Novartis Investigative Site Withdrawn
Bolzano, BZ, Italy, 39100
Novartis Investigative Site Completed
Cagliari, CA, Italy, 09100
Novartis Investigative Site Completed
Cagliari, CA, Italy, 09126
Novartis Investigative Site Completed
Cuneo, CN, Italy, 12100
Novartis Investigative Site Completed
Rossano, CS, Italy, 87067
Novartis Investigative Site Withdrawn
Catania, CT, Italy, 95124
Novartis Investigative Site Completed
Catanzaro, CZ, Italy, 88100
Novartis Investigative Site Completed
Cona, FE, Italy, 44100
Novartis Investigative Site Completed
San Giovanni Rotondo, FG, Italy, 71013
Novartis Investigative Site Completed
Firenze, FI, Italy, 50134
Novartis Investigative Site Completed
Genova, GE, Italy, 16132
Novartis Investigative Site Completed
Lecce, LE, Italy, 73100
Novartis Investigative Site Completed
Livorno, LI, Italy, 57124
Novartis Investigative Site Withdrawn
Messina, ME, Italy, 98125
Novartis Investigative Site Completed
Milano, MI, Italy, 20162
Novartis Investigative Site Completed
Milano, MI, Italy, 20122
Novartis Investigative Site Withdrawn
Monza, MI, Italy, 20052
Novartis Investigative Site Completed
Modena, MO, Italy, 41100
Novartis Investigative Site Completed
Nuoro, NU, Italy, 08100
Novartis Investigative Site Terminated
Palermo, PA, Italy, 90146
Novartis Investigative Site Withdrawn
Palermo, PA, Italy, 90146
Novartis Investigative Site Completed
Padova, PD, Italy, 35128
Novartis Investigative Site Completed
Pescara, PE, Italy, 65124
Novartis Investigative Site Completed
Pisa, PI, Italy, 56126
Novartis Investigative Site Completed
Pesaro, PU, Italy, 61100
Novartis Investigative Site Terminated
Pavia, PV, Italy, 27100
Novartis Investigative Site Completed
Potenza, PZ, Italy, 85100
Novartis Investigative Site Completed
Ravenna, RA, Italy, 48100
Novartis Investigative Site Completed
Reggio Calabria, RC, Italy, 89124
Novartis Investigative Site Completed
Reggio Emilia, RE, Italy, 42123
Novartis Investigative Site Completed
Roma, RM, Italy, 00161
Novartis Investigative Site Completed
Roma, RM, Italy, 00168
Novartis Investigative Site Completed
Roma, RM, Italy, 00144
Novartis Investigative Site Completed
Nocera Inferiore, SA, Italy, 84014
Novartis Investigative Site Completed
Siena, SI, Italy, 53100
Novartis Investigative Site Completed
Sassari, SS, Italy, 07100
Novartis Investigative Site Completed
Taranto, TA, Italy, 74100
Novartis Investigative Site Completed
Terni, TN, Italy, 05100
Novartis Investigative Site Completed
Orbassano, TO, Italy, 10043
Novartis Investigative Site Completed
Torino, TO, Italy, 10126
Novartis Investigative Site Completed
Treviso, TV, Italy, 31100
Novartis Investigative Site Withdrawn
Udine, UD, Italy, 33100
Novartis Investigative Site Withdrawn
Varese, VA, Italy, 21100
Novartis Investigative Site Withdrawn
Venezia, VE, Italy, 30174
Novartis Investigative Site Withdrawn
Vicenza, VI, Italy, 36100
Novartis Investigative Site Completed
Ronciglione, VT, Italy, 01100
Novartis Investigative Site Withdrawn
Napoli, Italy, 80136
Novartis Investigative Site Completed
Napoli, Italy, 80132
Novartis Investigative Site Completed
Napoli, Italy, 80131
Novartis Investigative Site Completed
Novara, Italy, 28100
Novartis Investigative Site Completed
Perugia, Italy, 06129
Netherlands
Novartis Investigative Site Completed
Amsterdam, Netherlands, 1081 HV
Novartis Investigative Site Completed
Delft, Netherlands, 2625 AD
Novartis Investigative Site Completed
Enschede, Netherlands, 7513 ER
Novartis Investigative Site Completed
Groningen, Netherlands, 9713 GZ
Novartis Investigative Site Completed
Nijmegen, Netherlands, 6525 GA
Novartis Investigative Site Completed
Rotterdam, Netherlands, 3075 EA
Novartis Investigative Site Active, not recruiting
Zwolle, Netherlands, 8025 AB
Norway
Novartis Investigative Site Completed
Bergen, Norway, NO-5021
Novartis Investigative Site Completed
Oslo, Norway, NO-0310
Novartis Investigative Site Completed
Stavanger, Norway, 4068
Novartis Investigative Site Completed
Tromsø, Norway, NO-9038
Novartis Investigative Site Completed
Trondheim, Norway, 7006
Poland
Novartis Investigative Site Recruiting
Gdansk, Poland, 80-952
Novartis Investigative Site Recruiting
Krakow, Poland, 30-510
Novartis Investigative Site Recruiting
Lublin, Poland, 20-081
Novartis Investigative Site Recruiting
Warsaw, Poland, 02-106
Novartis Investigative Site Not yet recruiting
Warszawa, Poland, 02-776
Novartis Investigative Site Recruiting
Wroclaw, Poland, 50-367
Portugal
Novartis Investigative Site Active, not recruiting
Lisboa, Portugal, 1150
Novartis Investigative Site Terminated
Porto, Portugal, 4200-319
Novartis Investigative Site Active, not recruiting
Porto, Portugal, 4200-072
Slovakia
Novartis Investigative Site Active, not recruiting
Kosice, Slovak Republic, Slovakia, 04066
Novartis Investigative Site Completed
Bratislava, Slovakia, 851 07
Novartis Investigative Site Active, not recruiting
Martin, Slovakia, 03601
Spain
Novartis Investigative Site Withdrawn
Granada, Andalucia, Spain, 18014
Novartis Investigative Site Withdrawn
Malaga, Andalucia, Spain, 29010
Novartis Investigative Site Withdrawn
Málaga, Andalucia, Spain, 29010
Novartis Investigative Site Withdrawn
Sevilla, Andalucia, Spain, 41014
Novartis Investigative Site Withdrawn
Sevilla, Andalucia, Spain, 41009
Novartis Investigative Site Withdrawn
Sevilla, Andalucia, Spain, 41013
Novartis Investigative Site Withdrawn
Jaen, Andalucía, Spain, 28007
Novartis Investigative Site Completed
Oviedo, Asturias, Spain, 33006
Novartis Investigative Site Active, not recruiting
Santander, Cantabria, Spain, 39008
Novartis Investigative Site Active, not recruiting
Toledo, Castilla la Mancha, Spain, 45004
Novartis Investigative Site Active, not recruiting
Salamanca, Castilla y Leon, Spain, 37007
Novartis Investigative Site Withdrawn
Hospitalet de LLobregat, Catalunya, Spain, 08907
Novartis Investigative Site Completed
Badalona, Cataluña, Spain, 08916
Novartis Investigative Site Completed
Barcelona, Cataluña, Spain, 08036
Novartis Investigative Site Active, not recruiting
Barcelona, Cataluña, Spain, 08035
Novartis Investigative Site Completed
Barcelona, Cataluña, Spain, 08025
Novartis Investigative Site Completed
Barcelona, Cataluña, Spain, 08003
Novartis Investigative Site Completed
Tarragona, Cataluña, Spain, 43007
Novartis Investigative Site Completed
Terrassa, Cataluña, Spain, 08221
Novartis Investigative Site Active, not recruiting
Valencia, Comunidad Valenciana, Spain, 46010
Novartis Investigative Site Withdrawn
Valencia, Comunidad Valenciana, Spain, 46026
Novartis Investigative Site Completed
La Coruna, Galicia, Spain, 15006
Novartis Investigative Site Completed
Orense, Galicia, Spain, 32005
Novartis Investigative Site Withdrawn
Santiago de Compostela, Galicia, Spain, 15706
Novartis Investigative Site Withdrawn
Palma De Mallorca, Islas Baleares, Spain, 07120
Novartis Investigative Site Active, not recruiting
Las Palmas de Gran Canaria, Las Palmas de G.C, Spain, 35010
Novartis Investigative Site Completed
La Laguna, Las Palmas de Gran Canaria, Spain, 38320
Novartis Investigative Site Active, not recruiting
Majadanonda, Madrid, Spain, 28220
Novartis Investigative Site Completed
Elche, Murcia, Spain, 03202
Novartis Investigative Site Completed
Pamplona, Navarra, Spain, 31008
Novartis Investigative Site Active, not recruiting
Baracaldo, Pais Vasco, Spain, 48903
Novartis Investigative Site Active, not recruiting
Bilbao, Pais Vasco, Spain, 48013
Novartis Investigative Site Withdrawn
Galdakano, Pais Vasco, Spain, 48960
Novartis Investigative Site Active, not recruiting
San Sebastian, Pais Vasco, Spain, 20014
Novartis Investigative Site Withdrawn
Gasteiz, País Vasco, Spain, 01009
Novartis Investigative Site Active, not recruiting
Madrid, Spain, 28034
Novartis Investigative Site Completed
Madrid, Spain, 28046
Novartis Investigative Site Active, not recruiting
Madrid, Spain, 28041
Novartis Investigative Site Completed
Madrid, Spain, 28040
Novartis Investigative Site Active, not recruiting
Madrid, Spain, 28006
Novartis Investigative Site Completed
Murcia, Spain, 30008
Novartis Investigative Site Completed
Zaragoza, Spain, 50009
Novartis Investigative Site Active, not recruiting
Zaragoza, Spain, 50009
Sweden
Novartis Investigative Site Completed
Göteborg, Sweden, SE-413 45
Novartis Investigative Site Completed
Linköping, Sweden, SE-581 85
Novartis Investigative Site Completed
Luleå, Sweden, SE-971 80
Novartis Investigative Site Active, not recruiting
Lund, Sweden, SE-221 85
Novartis Investigative Site Completed
Stockholm, Sweden, SE-118 83
Novartis Investigative Site Completed
Stockholm, Sweden, SE-171 76
Novartis Investigative Site Withdrawn
Sundsvall, Sweden, SE-851 86
Novartis Investigative Site Completed
Umeå, Sweden, SE-901 85
Novartis Investigative Site Active, not recruiting
Uppsala, Sweden, SE-751 85
Novartis Investigative Site Withdrawn
Örebro, Sweden, SE-701 85
Switzerland
Novartis Investigative Site Withdrawn
Münsterlingen, CHE, Switzerland, 8596
Novartis Investigative Site Withdrawn
Sion, CH, Switzerland, 1950
Novartis Investigative Site Active, not recruiting
Bern, Switzerland, 3010
Novartis Investigative Site Active, not recruiting
Chur, Switzerland, 7000
Novartis Investigative Site Completed
Genève, Switzerland, 1211
Novartis Investigative Site Completed
Zurich, Switzerland, 8091
United Kingdom
Novartis Investigative Site Active, not recruiting
Uxbridge, London, United Kingdom, UB8 3NN
Novartis Investigative Site Withdrawn
Worthing, West Sussex, United Kingdom, BN11 2DH
Novartis Investigative Site Active, not recruiting
Cardiff, United Kingdom, CF14 4XW
Novartis Investigative Site Active, not recruiting
Dudley, United Kingdom, DY1 2HQ
Novartis Investigative Site Active, not recruiting
London, United Kingdom, SE5 9RS
Novartis Investigative Site Active, not recruiting
London, United Kingdom, W12 0HS
Novartis Investigative Site Completed
Nottingham, United Kingdom, NG5
Novartis Investigative Site Active, not recruiting
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01061177     History of Changes
Other Study ID Numbers: CAMN107EIC01, 2009-017775-19
Study First Received: February 1, 2010
Last Updated: January 12, 2014
Health Authority: United States: Food and Drug Administration
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Bosnia: Federal Ministry of Health
Bulgaria: Bulgarian Drug Agency
Croatia: Ministry of Health and Social Care
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Estonia: The State Agency of Medicine
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
Greece: National Organization of Medicines
Italy: The Italian Medicines Agency
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Leukemia
myeloid
myelogenous
chronic BCR-ABL positive
Nilotinib

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014