PLEASE NOTE: This study has been imported from ClinicalTrials.gov without additional data checks.

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1 PLEASE NOTE: This study has been imported from ClinicalTrials.gov without additional data checks. Trial Description 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 Trial Acronym `MACS1252 URL of the trial [---]* Brief Summary in Lay Language 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. Brief Summary in Scientific Language [---]* Organizational Data DRKS-ID: DRKS Date of Registration in Partner Registry or other Primary Registry: 2010/02/01 Investigator Sponsored/Initiated Trial (IST/IIT): no Ethics Approval/Approval of the Ethics Committee: [---]* (leading) Ethics Committee Nr.: [---]* Page 1 of 10

2 Secondary IDs EudraCT-No. (for studies acc. to Drug Law): Primary Registry-ID: NCT (ClinicalTrials.gov) Sponsor-ID: CAMN107EIC01 (Novartis Pharmaceuticals) Other Secondary-ID: Health condition or Problem studied Free text: Leukemia, Myeloid ICD10: C Chronic myeloid leukaemia Interventions/Observational Groups Arm 1: Drug: Nilotinib Characteristics Study Type: Interventional Study Type Non-Interventional: [---]* Allocation: Single arm study Blinding: [---]* Who is blinded: [---]* Control: Uncontrolled/Single arm Purpose: Treatment Assignment: Single (group) Phase: IV Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): [---]* Primary Outcome - 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; 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. Page 2 of 10

3 Secondary Outcome - 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 - 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 - The rate of early events, event free survival, overall survival; and safety and tolerability of nilotinib; time frame: at 12 and 24 months - Exploratory endpoints patterns; time frame: at, as well as, by 3, 6, 9, 12, 15, 21, and 24 months; Exploratory endpoints include the kinetics of MMR and the dynamics of molecular response and potential patterns Countries of recruitment AT Austria BE Belgium CZ Czech Republic DK Denmark FI Finland FR France DE Germany GR Greece HU Hungary IT Italy NL Netherlands NO Norway PL Poland PT Portugal SK Slovakia ES Spain SE Sweden CH Switzerland UK United Kingdom Locations of Recruitment Page 3 of 10

4 Novartis Investigative Site, Aachen Novartis Investigative Site, Aschaffenburg Novartis Investigative Site, Augsburg Novartis Investigative Site, Bamberg Novartis Investigative Site, Bayreuth Novartis Investigative Site, Berlin Novartis Investigative Site, Berlin Novartis Investigative Site, Berlin Novartis Investigative Site, Berlin Novartis Investigative Site, Bielefeld Novartis Investigative Site, Bielefeld Novartis Investigative Site, Bonn Novartis Investigative Site, Bottrop Novartis Investigative Site, Bremen Novartis Investigative Site, Cottbus Novartis Investigative Site, Detmold Novartis Investigative Site, Donauwoerth Novartis Investigative Site, Dresden Novartis Investigative Site, Dresden Novartis Investigative Site, Dresden Novartis Investigative Site, Duesseldorf Novartis Investigative Site, Duisburg Novartis Investigative Site, Eisenach Novartis Investigative Site, Erlangen Novartis Investigative Site, Eschweiler Novartis Investigative Site, Essen Novartis Investigative Site, Essen Novartis Investigative Site, Frankfurt Novartis Investigative Site, Frankfurt Novartis Investigative Site, Frankfurt, Oder Novartis Investigative Site, Freiburg Novartis Investigative Site, Fulda Page 4 of 10

5 Novartis Investigative Site, Garmisch-Partenkirchen Novartis Investigative Site, Gerlingen Novartis Investigative Site, Germering Novartis Investigative Site, Giessen Novartis Investigative Site, Goettingen Novartis Investigative Site, Goslar Novartis Investigative Site, Greifswald Novartis Investigative Site, Groitzsch Novartis Investigative Site, Göttingen Novartis Investigative Site, Gütersloh Novartis Investigative Site, Hagen Novartis Investigative Site, Halberstadt Novartis Investigative Site, Halle Novartis Investigative Site, Hamburg Novartis Investigative Site, Hamburg Novartis Investigative Site, Hamburg Novartis Investigative Site, Hamm Novartis Investigative Site, Hannover Novartis Investigative Site, Hannover Novartis Investigative Site, Herrsching Novartis Investigative Site, Hildesheim Novartis Investigative Site, Homburg Novartis Investigative Site, Jena Novartis Investigative Site, Jena Novartis Investigative Site, Karlsruhe Novartis Investigative Site, Karlsruhe Novartis Investigative Site, Kassel Novartis Investigative Site, Kassel Novartis Investigative Site, Kempten Novartis Investigative Site, Kiel Novartis Investigative Site, Koblenz Novartis Investigative Site, Kronach Page 5 of 10

6 Novartis Investigative Site, Köln Novartis Investigative Site, Landshut Novartis Investigative Site, Leipzig Novartis Investigative Site, Leipzig Novartis Investigative Site, Lemgo Novartis Investigative Site, Leverkusen Novartis Investigative Site, Loerrach Novartis Investigative Site, Luebeck Novartis Investigative Site, Magdeburg Novartis Investigative Site, Mainz Novartis Investigative Site, Mannheim Novartis Investigative Site, Marburg Novartis Investigative Site, Marburg Novartis Investigative Site, Moers Novartis Investigative Site, Muelheim Novartis Investigative Site, Muenchen Novartis Investigative Site, Muenchen Novartis Investigative Site, Muenchen Novartis Investigative Site, Muenchen Novartis Investigative Site, Muenchen Novartis Investigative Site, Muenster Novartis Investigative Site, Mutlangen Novartis Investigative Site, Mönchengladbach Novartis Investigative Site, München Novartis Investigative Site, Neunkirchen Novartis Investigative Site, Northeim Novartis Investigative Site, Nuernberg Novartis Investigative Site, Nuernberg Novartis Investigative Site, Nuernberg Novartis Investigative Site, Offenburg Novartis Investigative Site, Paderborn Novartis Investigative Site, Passau Page 6 of 10

7 Novartis Investigative Site, Pinneberg Novartis Investigative Site, Pluederhausen Novartis Investigative Site, Ravensburg Novartis Investigative Site, Regensburg Novartis Investigative Site, Rehling Novartis Investigative Site, Rostock Novartis Investigative Site, Rotenburg Novartis Investigative Site, Schwäbisch-Hall Novartis Investigative Site, Sindelfingen Novartis Investigative Site, Sonneberg Novartis Investigative Site, Stuttgart Novartis Investigative Site, Stuttgart Novartis Investigative Site, Traunstein Novartis Investigative Site, Triberg Novartis Investigative Site, Ulm Novartis Investigative Site, Velbert Novartis Investigative Site, Viersen Novartis Investigative Site, Villingen Novartis Investigative Site, Villingen-Schwenningen Novartis Investigative Site, Waiblingen Novartis Investigative Site, Weiden Novartis Investigative Site, Weilheim Novartis Investigative Site, Wendlingen Novartis Investigative Site, Wuerzburg Novartis Investigative Site, Würzburg Novartis Investigative Site, Zella-Mehlis Recruitment Planned/Actual: Actual (Anticipated or Actual) Date of First Enrollment: 2010/05/31 Target Sample Size: 936 Monocenter/Multicenter trial: Multicenter trial National/International: International Inclusion Criteria Page 7 of 10

8 Gender: Both, male and female Minimum Age: 18 Years Maximum Age: no maximum age Additional 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 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 Page 8 of 10

9 Addresses Primary Sponsor Novartis Pharmaceuticals Telephone: [---]* Fax: [---]* [---]* URL: [---]* Contact for Scientific Queries Novartis Pharmaceuticals Novartis Pharmaceuticals Telephone: [---]* Fax: [---]* [---]* URL: [---]* Contact for Public Queries Novartis Pharmaceuticals Telephone: Fax: [---]* [---]* URL: [---]* Sources of Monetary or Material Support Commercial (pharmaceutical industry, medical engineering industry, etc.) Telephone: [---]* Fax: [---]* [---]* URL: [---]* Status Recruitment Status: Recruiting ongoing Study Closing (LPLV): [---]* Page 9 of 10

10 Trial Publications, Results and other documents The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs. - Translation on version: 12 - Last processed date by ClinicalTrials.gov: 2013/10/30 * This entry means the parameter is not applicable or has not been set.