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

January 4, 2017 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1090

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • AMN107

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 12 and 24 months
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.
at 12 and 24 months
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.
12 months, 24 months
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.
12 and 24 months
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.
12 and 24 months
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.
at 12 months
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).
at 12 months
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.
12 months, 24 months
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.
12 and 24 months
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).
12 and 24 months
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.
12 months, 24 months
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.
12 months, 24 months
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
by 18 months
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
by 18 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

February 1, 2010

First Submitted That Met QC Criteria

February 1, 2010

First Posted (Estimate)

February 2, 2010

Study Record Updates

Last Update Posted (Actual)

February 24, 2017

Last Update Submitted That Met QC Criteria

January 4, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAMN107EIC01
  • 2009-017775-19 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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