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AzTrials

CML in Chronic PhasePhase 4'MACS1252NCT01061177

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

A Phase 4 study testing Nilotinib in people with CML in Chronic Phase, run by Novartis Pharmaceuticals at 320 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
CML in Chronic Phase
What is being tested?
Nilotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,090 participants
Where
320 sitesin 26 countries
Study dates
May 2010to Jul 2014
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

320 sites in 26 countries.

320 sites in 26 countries

Germany80 sites

  • Novartis Investigative Site

    Aachen, 52074

  • Novartis Investigative Site

    Aschaffenburg, 63739

  • Novartis Investigative Site

    Augsburg, 86156

  • Novartis Investigative Site

    Bamberg, 96049

  • Novartis Investigative Site

    Bayreuth, 95445

  • Novartis Investigative Site

    Berlin, 10707

  • Novartis Investigative Site

    Berlin, 10709

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Berlin, 14195

  • Novartis Investigative Site

    Bielefeld, 33604

  • Novartis Investigative Site

    Bonn, 53105

  • Novartis Investigative Site

    Bottrop, 46236

  • Novartis Investigative Site

    Bremen, 28177

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Duisburg, 47166

  • Novartis Investigative Site

    Düsseldorf, 40225

  • Novartis Investigative Site

    Eisenach, 99817

  • Novartis Investigative Site

    Eschweiler, Germany, 52249

  • Novartis Investigative Site

    Essen, 45136

  • Novartis Investigative Site

    Essen, 45147

  • Novartis Investigative Site

    Frankfurt, 60590

  • Novartis Investigative Site

    Frankfurt, 60596

  • Novartis Investigative Site

    Frankfurt (Oder), 15236

  • Novartis Investigative Site

    Freiburg im Breisgau, 79106

  • Novartis Investigative Site

    Fulda, 36043

  • Novartis Investigative Site

    Giessen, 35392

  • Novartis Investigative Site

    Goslar, 38642

  • Novartis Investigative Site

    Greifswald, 17475

  • Novartis Investigative Site

    Hagen, 58097

  • Novartis Investigative Site

    Hamburg, 20246

  • Novartis Investigative Site

    Hamm, 59063

  • Novartis Investigative Site

    Hanover, 30170

  • Novartis Investigative Site

    Hanover, 30625

  • Novartis Investigative Site

    Herrsching am Ammersee, 82211

  • Novartis Investigative Site

    Hildesheim, 31134

  • Novartis Investigative Site

    Jena, 07740

  • Novartis Investigative Site

    Karlsruhe, 76133

  • Novartis Investigative Site

    Karlsruhe, 76135

  • Novartis Investigative Site

    Kassel, 34119

  • Novartis Investigative Site

    Kassel, 34125

  • Novartis Investigative Site

    Kiel, Germany, 24116

  • Novartis Investigative Site

    Koblenz, 56068

  • Novartis Investigative Site

    Landshut, 84028

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    Lemgo, 32657

  • Novartis Investigative Site

    Lübeck, 23563

  • Novartis Investigative Site

    Magdeburg, 39104

  • Novartis Investigative Site

    Mainz, Germany, 55131

  • Novartis Investigative Site

    Mannheim, 68169

  • Novartis Investigative Site

    Marburg, 35039

  • Novartis Investigative Site

    Moers, 47441

  • Novartis Investigative Site

    Mönchengladbach, 41063

  • Novartis Investigative Site

    Mülheim, 45468

  • Novartis Investigative Site

    München, 80335

  • Novartis Investigative Site

    München, 81241

  • Novartis Investigative Site

    München, 81675

  • Novartis Investigative Site

    München, 81737

  • Novartis Investigative Site

    Münster, 48149

  • Novartis Investigative Site

    Mutlangen, 73557

  • Novartis Investigative Site

    Neunkirchen, 66538

  • Novartis Investigative Site

    Nuremberg, 90419

  • Novartis Investigative Site

    Nuremberg, 90449

  • Novartis Investigative Site

    Offenburg, 77652

  • Novartis Investigative Site

    Paderborn, 33102

  • Novartis Investigative Site

    Ravensburg, 88214

  • Novartis Investigative Site

    Rostock, 18057

  • Novartis Investigative Site

    Schorndorf, 73614

  • Novartis Investigative Site

    Schwäbisch Hall, 74523

  • Novartis Investigative Site

    Sindelfingen, 71065

  • Novartis Investigative Site

    Stuttgart, 70376

  • Novartis Investigative Site

    Traunstein, 83278

  • Novartis Investigative Site

    Triberg, 78098

  • Novartis Investigative Site

    Ulm, 89081

  • Novartis Investigative Site

    Velbert, 42551

  • Novartis Investigative Site

    Viersen, 45468

  • Novartis Investigative Site

    Weilheim, 82362

  • Novartis Investigative Site

    Wendlingen, 73240

  • Novartis Investigative Site

    Würzburg, 97080

  • Novartis Investigative Site

    Zella-Mehlis, 98544

Other trials in Germany

France56 sites

  • Novartis Investigative Site

    Aix-en-Provence, 13616

  • Novartis Investigative Site

    Amiens Cedex1, 80054

  • Novartis Investigative Site

    Angers, France, 49033

  • Novartis Investigative Site

    Argenteuil, 95107

  • Novartis Investigative Site

    Avignon, 84902

  • Novartis Investigative Site

    Bayonne, Bayonne Cedex, 64109

  • Novartis Investigative Site

    Besançon, 25030

  • Novartis Investigative Site

    Blois, 41016

  • Novartis Investigative Site

    Bordeaux, 33076

  • Novartis Investigative Site

    Brest, 29200

  • Novartis Investigative Site

    Caen, 14000

  • Novartis Investigative Site

    Chalon-sur-Saône, 71321

  • Novartis Investigative Site

    Chambéry, 73011

  • Novartis Investigative Site

    Clermont-Ferrand, 63003

  • Novartis Investigative Site

    Compiègne, 60321

  • Novartis Investigative Site

    Corbeil-Essonnes, 91100

  • Novartis Investigative Site

    Créteil, 94010

  • Novartis Investigative Site

    Dijon, 21034

  • Novartis Investigative Site

    Dunkirk, France, 59240

  • Novartis Investigative Site

    Grenoble, 38043

  • Novartis Investigative Site

    La Roche-sur-Yon, 85925

  • Novartis Investigative Site

    Le Chesnay, 78157

  • Novartis Investigative Site

    Le Coudray, 28630

  • Novartis Investigative Site

    Le Mans, 72037

  • Novartis Investigative Site

    Lens, 62307

  • Novartis Investigative Site

    Lille, 59020

  • Novartis Investigative Site

    Limoges, 87042

  • Novartis Investigative Site

    Mâcon, 71018

  • Novartis Investigative Site

    Marseille, 13273

  • Novartis Investigative Site

    Marseille, 13915

  • Novartis Investigative Site

    Metz, 57038

  • Novartis Investigative Site

    Monte-Carlo, Principauté de Monaco, 98012

  • Novartis Investigative Site

    Montfermeil, 93370

  • Novartis Investigative Site

    Montpellier, 34295

  • Novartis Investigative Site

    Mulhouse, 68070

  • Novartis Investigative Site

    Nantes, 44035

  • Novartis Investigative Site

    Nice, 06189

  • Novartis Investigative Site

    Nîmes, 32900

  • Novartis Investigative Site

    Paris, Cedex 10, 75475

  • Novartis Investigative Site

    Paris, 75012

  • Novartis Investigative Site

    Pau, 64000

  • Novartis Investigative Site

    Perpignan, 66046

  • Novartis Investigative Site

    Pringy, 74374

  • Novartis Investigative Site

    Reims, 51092

  • Novartis Investigative Site

    Rennes, 35019

  • Novartis Investigative Site

    Roubaix, 59100

  • Novartis Investigative Site

    Rouen, 76038

  • Novartis Investigative Site

    Saint-Brieuc, 22027

  • Novartis Investigative Site

    Saint-Denis, France / La Reunion, 97405

  • Novartis Investigative Site

    Saint-Priest-en-Jarez, 42271

  • Novartis Investigative Site

    Saint-Quentin, 02321

  • Novartis Investigative Site

    Strasbourg, 67085

  • Novartis Investigative Site

    Strasbourg, 67091

  • Novartis Investigative Site

    Toulouse, 31059

  • Novartis Investigative Site

    Tours, 37044

  • Novartis Investigative Site

    Troyes, 10003

Other trials in France

Italy47 sites

  • Novartis Investigative Site

    Ancona, AN, 60126

  • Novartis Investigative Site

    Avellino, AV, 83100

  • Novartis Investigative Site

    Bari, BA, 70124

  • Novartis Investigative Site

    Bologna, BO, 40138

  • Novartis Investigative Site

    Brescia, BS, 25123

  • Novartis Investigative Site

    Brindisi, BR, 72100

  • Novartis Investigative Site

    Cagliari, CA, 09121

  • Novartis Investigative Site

    Cagliari, CA, 09126

  • Novartis Investigative Site

    Catanzaro, CZ, 88100

  • Novartis Investigative Site

    Cona, FE, 44100

  • Novartis Investigative Site

    Cuneo, CN, 12100

  • Novartis Investigative Site

    Florence, FI, 50134

  • Novartis Investigative Site

    Genova, GE, 16132

  • Novartis Investigative Site

    Lecce, LE, 73100

  • Novartis Investigative Site

    Livorno, LI, 57124

  • Novartis Investigative Site

    Milan, MI, 20122

  • Novartis Investigative Site

    Milan, MI, 20162

  • Novartis Investigative Site

    Modena, MO, 41100

  • Novartis Investigative Site

    Naples, 80131

  • Novartis Investigative Site

    Naples, 80132

  • Novartis Investigative Site

    Nocera Inferiore, SA, 84014

  • Novartis Investigative Site

    Novara, 28100

  • Novartis Investigative Site

    Nuoro, NU, 08100

  • Novartis Investigative Site

    Orbassano, TO, 10043

  • Novartis Investigative Site

    Padova, PD, 35128

  • Novartis Investigative Site

    Palermo, PA, 90146

  • Novartis Investigative Site

    Pavia, PV, 27100

  • Novartis Investigative Site

    Perugia, 06129

  • Novartis Investigative Site

    Pesaro, PU, 61100

  • Novartis Investigative Site

    Pescara, PE, 65124

  • Novartis Investigative Site

    Pisa, PI, 56126

  • Novartis Investigative Site

    Potenza, PZ, 85100

  • Novartis Investigative Site

    Ravenna, RA, 48100

  • Novartis Investigative Site

    Reggio Calabria, RC, 89124

  • Novartis Investigative Site

    Reggio Emilia, RE, 42123

  • Novartis Investigative Site

    Roma, RM, 00144

  • Novartis Investigative Site

    Roma, RM, 00161

  • Novartis Investigative Site

    Rome, Lazio, 00168

  • Novartis Investigative Site

    Ronciglione, VT, 01100

  • Novartis Investigative Site

    Rossano, CS, 87067

  • Novartis Investigative Site

    San Giovanni Rotondo, FG, 71013

  • Novartis Investigative Site

    Sassari, SS, 07100

  • Novartis Investigative Site

    Siena, SI, 53100

  • Novartis Investigative Site

    Taranto, TA, 74100

  • Novartis Investigative Site

    Terni, TR, 05100

  • Novartis Investigative Site

    Torino, TO, 10126

  • Novartis Investigative Site

    Treviso, TV, 31100

Other trials in Italy

Spain29 sites

  • Novartis Investigative Site

    A Coruña, Galicia, 15006

  • Novartis Investigative Site

    Badalona, Catalonia, 08916

  • Novartis Investigative Site

    Barakaldo, Vizcaya, 48903

  • Novartis Investigative Site

    Barcelona, Barcelona, 08041

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035

  • Novartis Investigative Site

    Barcelona, Catalonia, 08036

  • Novartis Investigative Site

    Bilbao, Basque Country, 48013

  • Novartis Investigative Site

    Donostia / San Sebastian, Basque Country, 20080

  • Novartis Investigative Site

    Elche, Alicante, 03203

  • Novartis Investigative Site

    Las Palmas de Gran Canaria, Las Palmas de G.C, 35010

  • Novartis Investigative Site

    Madrid, Madrid, 28006

  • Novartis Investigative Site

    Madrid, Madrid, 28034

  • Novartis Investigative Site

    Madrid, Madrid, 28040

  • Novartis Investigative Site

    Madrid, Madrid, 28041

  • Novartis Investigative Site

    Madrid, Madrid, 28046

  • Novartis Investigative Site

    Majadahonda, Madrid, 28222

  • Novartis Investigative Site

    Murcia, Murcia, 30008

  • Novartis Investigative Site

    Ourense, Galicia, 32005

  • Novartis Investigative Site

    Oviedo, Principality of Asturias, 33006

  • Novartis Investigative Site

    Pamplona, Navarre, 31008

  • Novartis Investigative Site

    Salamanca, Castille and León, 37007

  • Novartis Investigative Site

    San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320

  • Novartis Investigative Site

    Santander, Cantabria, 39008

  • Novartis Investigative Site

    Tarragona, Catalonia, 43005

  • Novartis Investigative Site

    Terrassa, Catalonia, 08221

  • Novartis Investigative Site

    Toledo, Castille-La Mancha, 45071

  • Novartis Investigative Site

    Valencia, Valencia, 46010

  • Novartis Investigative Site

    Zaragoza, Zaragoza, 50009

Other trials in Spain

Belgium16 sites

  • Novartis Investigative Site

    Aalst, Belgium, 9300

  • Novartis Investigative Site

    Bruges, 8000

  • Novartis Investigative Site

    Brussels, 1000

  • Novartis Investigative Site

    Brussels, 1070

  • Novartis Investigative Site

    Brussels, 1090

  • Novartis Investigative Site

    Brussels, BE-B-1200

  • Novartis Investigative Site

    Charleroi, 6000

  • Novartis Investigative Site

    Edegem, 2650

  • Novartis Investigative Site

    Ghent, 9000

  • Novartis Investigative Site

    Hasselt, 3500

  • Novartis Investigative Site

    Laken, 1020

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Luxembourg, Luxembourg, 1210

  • Novartis Investigative Site

    Roeselare, 8800

  • Novartis Investigative Site

    Verviers, 4800

  • Novartis Investigative Site

    Yvoir, 5530

Other trials in Belgium

Austria8 sites

  • Novartis Investigative Site

    Graz, 8036

  • Novartis Investigative Site

    Innsbruck, A-6020

  • Novartis Investigative Site

    Linz, 4010

  • Novartis Investigative Site

    Rankweil, A-6830

  • Novartis Investigative Site

    Salzburg, 5020

  • Novartis Investigative Site

    Vienna, A-1130

  • Novartis Investigative Site

    Vienna, A-1140

  • Novartis Investigative Site

    Wels, Austria, A-4600

Other trials in Austria

Sweden8 sites

  • Novartis Investigative Site

    Gothenburg, SE-413 45

  • Novartis Investigative Site

    Huddinge, SE-14186

  • Novartis Investigative Site

    Linköping, SE-581 85

  • Novartis Investigative Site

    Luleå, SE-971 80

  • Novartis Investigative Site

    Lund, SE-221 85

  • Novartis Investigative Site

    Stockholm, SE-171 76

  • Novartis Investigative Site

    Umeå, SE-901 85

  • Novartis Investigative Site

    Uppsala, SE-751 85

Other trials in Sweden

Greece7 sites

  • Novartis Investigative Site

    Alexandroupoli, Evros, 68100

  • Novartis Investigative Site

    Athens, Greece, 11527

  • Novartis Investigative Site

    Athens, GR, 115 27

  • Novartis Investigative Site

    Heraklion Crete, Greece, 711 10

  • Novartis Investigative Site

    Larissa, GR, 411 10

  • Novartis Investigative Site

    Pátrai, Greece, 265 00

  • Novartis Investigative Site

    Thessaloniki, GR, 546 42

Other trials in Greece

Netherlands7 sites

  • Novartis Investigative Site

    Amsterdam, 1081 HV

  • Novartis Investigative Site

    Delft, 2625 AD

  • Novartis Investigative Site

    Enschede, 7513 ER

  • Novartis Investigative Site

    Groningen, 9713 GZ

  • Novartis Investigative Site

    Nijmegen, 6525 GA

  • Novartis Investigative Site

    Rotterdam, 3075 EA

  • Novartis Investigative Site

    Zwolle, 8025 AB

Other trials in Netherlands

United Kingdom7 sites

  • Novartis Investigative Site

    Cardiff, CF14 4XW

  • Novartis Investigative Site

    Dudley, DY1 2HQ

  • Novartis Investigative Site

    London, SE5 9RS

  • Novartis Investigative Site

    London, W12 0HS

  • Novartis Investigative Site

    Nottingham, NG5

  • Novartis Investigative Site

    Oxford, OX3 7LJ

  • Novartis Investigative Site

    Uxbridge, London, UB8 3NN

Other trials in United Kingdom

Poland6 sites

  • Novartis Investigative Site

    Gdansk, 80-952

  • Novartis Investigative Site

    Krakow, 30-510

  • Novartis Investigative Site

    Lublin, 20-081

  • Novartis Investigative Site

    Warsaw, Poland, 02-106

  • Novartis Investigative Site

    Warsaw, 02-776

  • Novartis Investigative Site

    Wroclaw, 50-367

Other trials in Poland

Romania6 sites

  • Novartis Investigative Site

    Bucharest, District 2, 022328

  • Novartis Investigative Site

    Bucharest, Romania, 030171

  • Novartis Investigative Site

    Bucharest, 050098

  • Novartis Investigative Site

    Cluj-Napoca, 3400

  • Novartis Investigative Site

    Iași, Jud. Iasi, 700111

  • Novartis Investigative Site

    Timișoara, Romania, 300 079

Other trials in Romania

Bulgaria5 sites

  • Novartis Investigative Site

    Pleven, Bulgaria, 5800

  • Novartis Investigative Site

    Plovdiv, 4002

  • Novartis Investigative Site

    Sofia, 1431

  • Novartis Investigative Site

    Sofia, 1756

  • Novartis Investigative Site

    Varna, 9000

Other trials in Bulgaria

Hungary5 sites

  • Novartis Investigative Site

    Budapest, 1097

  • Novartis Investigative Site

    Debrecen, 4032

  • Novartis Investigative Site

    Kaposvár, 7400

  • Novartis Investigative Site

    Pécs, 7624

  • Novartis Investigative Site

    Szeged, H-6725

Other trials in Hungary

Norway5 sites

  • Novartis Investigative Site

    Bergen, NO-5021

  • Novartis Investigative Site

    Oslo, NO-0310

  • Novartis Investigative Site

    Stavanger, 4068

  • Novartis Investigative Site

    Tromsø, NO-9038

  • Novartis Investigative Site

    Trondheim, 7006

Other trials in Norway

Czechia4 sites

  • Novartis Investigative Site

    Brno-Bohunice, Czech Republic, 625 00

  • Novartis Investigative Site

    Hradec Králové, Czech Republic, 500 05

  • Novartis Investigative Site

    Olomouc, CZE, 775 20

  • Novartis Investigative Site

    Prague, Czech Republic, 128 20

Other trials in Czechia

Switzerland4 sites

  • Novartis Investigative Site

    Bern, 3010

  • Novartis Investigative Site

    Chur, 7000

  • Novartis Investigative Site

    Geneva, 1211

  • Novartis Investigative Site

    Zurich, Switzerland, 8091

Other trials in Switzerland

Denmark3 sites

  • Novartis Investigative Site

    Aarhus C, DK-8000

  • Novartis Investigative Site

    Copenhagen, DK-2100

  • Novartis Investigative Site

    Odense C, DK-5000

Other trials in Denmark

Lithuania3 sites

  • Novartis Investigative Site

    Kaunas, 3007

  • Novartis Investigative Site

    Klaipėda, LT-92231

  • Novartis Investigative Site

    Vilnius, LT-08661

Other trials in Lithuania

Portugal3 sites

  • Novartis Investigative Site

    Lisbon, Portugal, 1150-314

  • Novartis Investigative Site

    Porto, Portugal, 4200319

  • Novartis Investigative Site

    Porto, 4200-072

Other trials in Portugal

Slovakia3 sites

  • Novartis Investigative Site

    Bratislava, 851 07

  • Novartis Investigative Site

    Košice, Slovak Republic, 04066

  • Novartis Investigative Site

    Martin, Slovakia, 03601

Other trials in Slovakia

Croatia2 sites

  • Novartis Investigative Site

    Rijeka, 51000

  • Novartis Investigative Site

    Zagreb, 10000

Other trials in Croatia

Finland2 sites

  • Novartis Investigative Site

    HUS Helsinki, FIN-00029

  • Novartis Investigative Site

    Oulu, 900114

Other trials in Finland

Slovenia2 sites

  • Novartis Investigative Site

    Celje, 3000

  • Novartis Investigative Site

    Ljubljana, 1000

Other trials in Slovenia

Estonia1 site

  • Novartis Investigative Site

    Tartu, 51006

Other trials in Estonia

Latvia1 site

  • Novartis Investigative Site

    Riga, LV, 1006

Other trials in Latvia

About this study

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

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.

Being tested
Nilotinib
Keywords
Leukemia, myeloid, myelogenous, chronic BCR-ABL positive, Nilotinib, Philadelphia chromosome, CML in chronic phase
Medical subject headings
Leukemia, Philadelphia Chromosome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NilotinibDrug

    Also called AMN107

    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.

Study groups in NCT01061177
Study groupRoleWhat they receive
NilotinibExperimentalThis was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
Receives: Drug: Nilotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Molecular Response (MR4^0) 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.

    Measured: at 18 months

Secondary outcomes (15)

  1. Percentage of Participants Free From Progression to Accelerated Phase/Blast Crisis (AP/BC) 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.

    Measured: at 12 and 24 months

  2. Rate of Event Free Survival 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.

    Measured: at 12 and 24 months

  3. Percentage of Participants With Major Molecular Response (MMR) at, as Well as by, 12 and 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.

    Measured: 12 months, 24 months

  4. Percentage of Participants With Complete Cytogenetic Response (CCyR) at, as Well as by, 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.

    Measured: 12 and 24 months

  5. Percentage of Participants With Major Cytogenetic Response (MCyR) at, as Well as by, 12 and 24 Months

    Major cytogenetic response (MCyR) parameters were defined as 0 to 35% Philadelphia positive (Ph+) metaphases.

    Measured: 12 and 24 months

  6. Percentage of Participants Free From Progression to AP/BC With MR4^0 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.

    Measured: at 12 months

  7. Percentage of Participants With Event Free Survival in Participants Achieving MR4^0 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).

    Measured: at 12 months

  8. Percentage of Participants With Progression Free Survival (PFS) at 12 and 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.

    Measured: 12 months, 24 months

  9. Rate of Molecular Response (MR4^0) at, as Well as by, 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.

    Measured: 12 and 24 months

  10. Rate of Molecular Response (MR4^5) at, as Well as by, 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).

    Measured: 12 and 24 months

  11. Rate of Complete Hematologic Response (CHR) at, as Well as by, 12 and 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.

    Measured: 12 months, 24 months

  12. Percentage of Participants With Overall Survival at 12 and 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.

    Measured: 12 months, 24 months

  13. Rate of Molecular Response (MR4^0) 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

    Measured: by 18 months

  14. Rate of Molecular Response (MR4^5) 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

    Measured: by 18 months

  15. Percentage of Participants With Progression Free Survival in Participants Achieving MR4^0 at 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,090 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01061177
Sponsor's protocol ID
CAMN107EIC01
Other IDs
2009-017775-19, 2009
Acronym
'MACS1252
Status last verified
Dec 2016
First submitted
1 Feb 2010
Last updated
24 Feb 2017
Data monitoring committee
Yes

Publications

  • Gullaksen SE, Skavland J, Gavasso S, Tosevski V, Warzocha K, Dumrese C, Ferrant A, Gedde-Dahl T, Hellmann A, Janssen J, Labar B, Lang A, Majeed W, Mihaylov G, Stentoft J, Stenke L, Thaler J, Thielen N, Verhoef G, Voglova J, Ossenkoppele G, Hochhaus A, Hjorth-Hansen H, Mustjoki S, Sopper S, Giles F, Porkka K, Wolf D, Gjertsen BT. Single cell immune profiling by mass cytometry of newly diagnosed chronic phase chronic myeloid leukemia treated with nilotinib. Haematologica. 2017 Aug;102(8):1361-1367. doi: 10.3324/haematol.2017.167080. Epub 2017 May 18.

    PubMed 28522574

  • Thielen N, Richter J, Baldauf M, Barbany G, Fioretos T, Giles F, Gjertsen BT, Hochhaus A, Schuurhuis GJ, Sopper S, Stenke L, Thunberg S, Wolf D, Ossenkoppele G, Porkka K, Janssen J, Mustjoki S. Leukemic Stem Cell Quantification in Newly Diagnosed Patients With Chronic Myeloid Leukemia Predicts Response to Nilotinib Therapy. Clin Cancer Res. 2016 Aug 15;22(16):4030-8. doi: 10.1158/1078-0432.CCR-15-2791. Epub 2016 Mar 22.

    PubMed 27006491

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nilotinib in people with CML in Chronic Phase, run by Novartis Pharmaceuticals at 320 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 320 sites in Germany, France, Italy, Spain, Belgium and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Molecular Response (MR4^0) at 18 Months (time frame: at 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01061177, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2017.

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