Clinical trial NCT01061177: Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome & /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: CML in Chronic Phase
Keywords: Leukemia
myeloid
myelogenous
chronic BCR-ABL positive
Nilotinib
Philadelphia chromosome
CML in chronic phase
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-02-02
Enrollment: 1090
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Percentage of Participants With Molecular Response (MR4^0) at 18 Months
timeFrame: at 18 months
Secondary outcomes:
measure: Percentage of Participants Free From Progression to Accelerated Phase/Blast Crisis (AP/BC) at 12 and 24 Months
timeFrame: at 12 and 24 months
measure: Rate of Event Free Survival at 12 and 24 Months
timeFrame: at 12 and 24 months
measure: Percentage of Participants With Major Molecular Response (MMR) at, as Well as by, 12 and 24 Months
timeFrame: 12 months, 24 months
measure: Percentage of Participants With Complete Cytogenetic Response (CCyR) at, as Well as by, 12 and 24 Months
timeFrame: 12 and 24 months
measure: Percentage of Participants With Major Cytogenetic Response (MCyR) at, as Well as by, 12 and 24 Months
timeFrame: 12 and 24 months
measure: Percentage of Participants Free From Progression to AP/BC With MR4^0 at 12 Months
timeFrame: at 12 months
measure: Percentage of Participants With Event Free Survival in Participants Achieving MR4^0 at 12 Months
timeFrame: at 12 months
measure: Percentage of Participants With Progression Free Survival (PFS) at 12 and 24 Months
timeFrame: 12 months, 24 months
measure: Rate of Molecular Response (MR4^0) at, as Well as by, 12 and 24 Months
timeFrame: 12 and 24 months
measure: Rate of Molecular Response (MR4^5) at, as Well as by, 12 and 24 Months
timeFrame: 12 and 24 months
measure: Rate of Complete Hematologic Response (CHR) at, as Well as by, 12 and 24 Months
timeFrame: 12 months, 24 months
measure: Percentage of Participants With Overall Survival at 12 and 24 Months
timeFrame: 12 months, 24 months
measure: Rate of Molecular Response (MR4^0) by 18 Months
timeFrame: by 18 months
measure: Rate of Molecular Response (MR4^5) by 18 Months
timeFrame: by 18 months
measure: Percentage of Participants With Progression Free Survival in Participants Achieving MR4^0 at 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Novartis Investigative Site
city: Innsbruck
country: Austria
facility: Novartis Investigative Site
city: Linz
country: Austria
facility: Novartis Investigative Site
city: Rankweil
country: Austria
facility: Novartis Investigative Site
city: Salzburg
country: Austria
facility: Novartis Investigative Site
city: Vienna
country: Austria
facility: Novartis Investigative Site
city: Wels
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Aalst
country: Belgium
facility: Novartis Investigative Site
city: Brugge
country: Belgium
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city: Brussels
country: Belgium
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city: Brussel
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facility: Novartis Investigative Site
city: Bruxelles
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facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Charleroi
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facility: Novartis Investigative Site
city: Edegem
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facility: Novartis Investigative Site
city: Gent
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city: Hasselt
country: Belgium
facility: Novartis Investigative Site
city: Laeken
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facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Luxembourg
country: Belgium
facility: Novartis Investigative Site
city: Roeselare
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facility: Novartis Investigative Site
city: Verviers
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facility: Novartis Investigative Site
city: Yvoir
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city: Pleven
country: Bulgaria
facility: Novartis Investigative Site
city: Plovdiv
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
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city: Sofia
country: Bulgaria
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city: Varna
country: Bulgaria
facility: Novartis Investigative Site
city: Rijeka
country: Croatia
facility: Novartis Investigative Site
city: Zagreb
country: Croatia
facility: Novartis Investigative Site
city: Olomouc
country: Czech Republic
facility: Novartis Investigative Site
state: CZE
city: Brno - Bohunice
country: Czech Republic
facility: Novartis Investigative Site
city: Hradec Kralove
country: Czech Republic
facility: Novartis Investigative Site
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country: Czech Republic
facility: Novartis Investigative Site
city: Aarhus C
country: Denmark
facility: Novartis Investigative Site
city: Copenhagen
country: Denmark
facility: Novartis Investigative Site
city: Odense C
country: Denmark
facility: Novartis Investigative Site
city: Tartu
country: Estonia
facility: Novartis Investigative Site
city: HUS Helsinki
country: Finland
facility: Novartis Investigative Site
city: Oulu
country: Finland
facility: Novartis Investigative Site
city: Bayonne
country: France
facility: Novartis Investigative Site
state: Bayonne cedex
city: Paris Cedex 10
country: France
facility: Novartis Investigative Site
state: Cedex 10
city: Saint Denis
country: France
facility: Novartis Investigative Site
state: FRANCE / La Reunion
city: Monte-Carlo
country: France
facility: Novartis Investigative Site
state: Principauté de Monaco
city: Aix en Provence Cedex 1
country: France
facility: Novartis Investigative Site
city: Amiens cedex1
country: France
facility: Novartis Investigative Site
city: Angers Cedex 1
country: France
facility: Novartis Investigative Site
city: Argenteuil Cedex
country: France
facility: Novartis Investigative Site
city: Avignon cedex 9
country: France
facility: Novartis Investigative Site
city: Besancon cedex
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facility: Novartis Investigative Site
city: Blois Cedex
country: France
facility: Novartis Investigative Site
city: Bordeaux
country: France
facility: Novartis Investigative Site
city: Brest
country: France
facility: Novartis Investigative Site
city: Caen
country: France
facility: Novartis Investigative Site
city: Chalon sur Saône
country: France
facility: Novartis Investigative Site
city: Chambéry cedex
country: France
facility: Novartis Investigative Site
city: Clermont-Ferrand cedex 1
country: France
facility: Novartis Investigative Site
city: Compiègne cedex
country: France
facility: Novartis Investigative Site
city: Corbeil Essonnes
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facility: Novartis Investigative Site
city: Creteil
country: France
facility: Novartis Investigative Site
city: Dijon
country: France
facility: Novartis Investigative Site
city: Dunkerque
country: France
facility: Novartis Investigative Site
city: Grenoble
country: France
facility: Novartis Investigative Site
city: La Roche sur Yon cedex 9
country: France
facility: Novartis Investigative Site
city: Le Chesnay
country: France
facility: Novartis Investigative Site
city: Le Coudray
country: France
facility: Novartis Investigative Site
city: Le Mans Cedex 09
country: France
facility: Novartis Investigative Site
city: Lens Cedex
country: France
facility: Novartis Investigative Site
city: Lille cedex
country: France
facility: Novartis Investigative Site
city: Limoges cedex
country: France
facility: Novartis Investigative Site
city: Marseille cedex 20
country: France
facility: Novartis Investigative Site
city: Marseille
country: France
facility: Novartis Investigative Site
city: Metz Cedex 01
country: France
facility: Novartis Investigative Site
city: Montfermeil
country: France
facility: Novartis Investigative Site
city: Montpellier cedex 5
country: France
facility: Novartis Investigative Site
city: Mulhouse cedex
country: France
facility: Novartis Investigative Site
city: Mâcon Cedex
country: France
facility: Novartis Investigative Site
city: Nantes
country: France
facility: Novartis Investigative Site
city: Nice Cedex 2
country: France
facility: Novartis Investigative Site
city: Nimes
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Pau
country: France
facility: Novartis Investigative Site
city: Perpignan
country: France
facility: Novartis Investigative Site
city: Pringy cedex
country: France
facility: Novartis Investigative Site
city: Reims
country: France
facility: Novartis Investigative Site
city: Rennes
country: France
facility: Novartis Investigative Site
city: Roubaix
country: France
facility: Novartis Investigative Site
city: Rouen Cedex 1
country: France
facility: Novartis Investigative Site
city: Saint Brieuc cedex 1
country: France
facility: Novartis Investigative Site
city: Saint Priest en Jarez Cedex
country: France
facility: Novartis Investigative Site
city: St Quentin Cedex
country: France
facility: Novartis Investigative Site
city: Strasbourg cedex
country: France
facility: Novartis Investigative Site
city: Strasbourg cedex
country: France
facility: Novartis Investigative Site
city: Toulouse Cedex 9
country: France
facility: Novartis Investigative Site
city: Tours Cedex 9
country: France
facility: Novartis Investigative Site
city: Troyes
country: France
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Aachen
country: Germany
facility: Novartis Investigative Site
city: Aschaffenburg
country: Germany
facility: Novartis Investigative Site
city: Augsburg
country: Germany
facility: Novartis Investigative Site
city: Bamberg
country: Germany
facility: Novartis Investigative Site
city: Bayreuth
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bielefeld
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Bottrop
country: Germany
facility: Novartis Investigative Site
city: Bremen
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
city: Duisburg
country: Germany
facility: Novartis Investigative Site
city: Eisenach
country: Germany
facility: Novartis Investigative Site
city: Eschweiler
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Frankfurt, Oder
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Fulda
country: Germany
facility: Novartis Investigative Site
city: Giessen
country: Germany
facility: Novartis Investigative Site
city: Goslar
country: Germany
facility: Novartis Investigative Site
city: Greifswald
country: Germany
facility: Novartis Investigative Site
city: Hagen
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamm
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Herrsching
country: Germany
facility: Novartis Investigative Site
city: Hildesheim
country: Germany
facility: Novartis Investigative Site
city: Jena
country: Germany
facility: Novartis Investigative Site
city: Karlsruhe
country: Germany
facility: Novartis Investigative Site
city: Karlsruhe
country: Germany
facility: Novartis Investigative Site
city: Kassel
country: Germany
facility: Novartis Investigative Site
city: Kassel
country: Germany
facility: Novartis Investigative Site
city: Kiel
country: Germany
facility: Novartis Investigative Site
city: Koblenz
country: Germany
facility: Novartis Investigative Site
city: Landshut
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Lemgo
country: Germany
facility: Novartis Investigative Site
city: Luebeck
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Mannheim
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Moers
country: Germany
facility: Novartis Investigative Site
city: Muelheim
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Mutlangen
country: Germany
facility: Novartis Investigative Site
city: Mönchengladbach
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: Neunkirchen
country: Germany
facility: Novartis Investigative Site
city: Nuernberg
country: Germany
facility: Novartis Investigative Site
city: Nuernberg
country: Germany
facility: Novartis Investigative Site
city: Offenburg
country: Germany
facility: Novartis Investigative Site
city: Paderborn
country: Germany
facility: Novartis Investigative Site
city: Ravensburg
country: Germany
facility: Novartis Investigative Site
city: Rostock
country: Germany
facility: Novartis Investigative Site
city: Schorndorf
country: Germany
facility: Novartis Investigative Site
city: Schwäbisch-Hall
country: Germany
facility: Novartis Investigative Site
city: Sindelfingen
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
city: Traunstein
country: Germany
facility: Novartis Investigative Site
city: Triberg
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Velbert
country: Germany
facility: Novartis Investigative Site
city: Viersen
country: Germany
facility: Novartis Investigative Site
city: Weilheim
country: Germany
facility: Novartis Investigative Site
city: Wendlingen
country: Germany
facility: Novartis Investigative Site
city: Wuerzburg
country: Germany
facility: Novartis Investigative Site
city: Würzburg
country: Germany
facility: Novartis Investigative Site
city: Zella-Mehlis
country: Germany
facility: Novartis Investigative Site
city: Alexandroupolis
country: Greece
facility: Novartis Investigative Site
state: Evros
city: Athens
country: Greece
facility: Novartis Investigative Site
state: GR
city: Larissa
country: Greece
facility: Novartis Investigative Site
state: GR
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
state: GR
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Heraklion Crete
country: Greece
facility: Novartis Investigative Site
city: Patras
country: Greece
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Kaposvar
country: Hungary
facility: Novartis Investigative Site
city: Pecs
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Ancona
country: Italy
facility: Novartis Investigative Site
state: AN
city: Avellino
country: Italy
facility: Novartis Investigative Site
state: AV
city: Bari
country: Italy
facility: Novartis Investigative Site
state: BA
city: Bologna
country: Italy
facility: Novartis Investigative Site
state: BO
city: Brindisi
country: Italy
facility: Novartis Investigative Site
state: BR
city: Brescia
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facility: Novartis Investigative Site
state: BS
city: Cagliari
country: Italy
facility: Novartis Investigative Site
state: CA
city: Cagliari
country: Italy
facility: Novartis Investigative Site
state: CA
city: Cuneo
country: Italy
facility: Novartis Investigative Site
state: CN
city: Rossano
country: Italy
facility: Novartis Investigative Site
state: CS
city: Catanzaro
country: Italy
facility: Novartis Investigative Site
state: CZ
city: Cona
country: Italy
facility: Novartis Investigative Site
state: FE
city: San Giovanni Rotondo
country: Italy
facility: Novartis Investigative Site
state: FG
city: Firenze
country: Italy
facility: Novartis Investigative Site
state: FI
city: Genova
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facility: Novartis Investigative Site
state: GE
city: Roma
country: Italy
facility: Novartis Investigative Site
state: Lazio
city: Lecce
country: Italy
facility: Novartis Investigative Site
state: LE
city: Livorno
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facility: Novartis Investigative Site
state: LI
city: Milano
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facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Modena
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facility: Novartis Investigative Site
state: MO
city: Nuoro
country: Italy
facility: Novartis Investigative Site
state: NU
city: Palermo
country: Italy
facility: Novartis Investigative Site
state: PA
city: Padova
country: Italy
facility: Novartis Investigative Site
state: PD
city: Pescara
country: Italy
facility: Novartis Investigative Site
state: PE
city: Pisa
country: Italy
facility: Novartis Investigative Site
state: PI
city: Pesaro
country: Italy
facility: Novartis Investigative Site
state: PU
city: Pavia
country: Italy
facility: Novartis Investigative Site
state: PV
city: Potenza
country: Italy
facility: Novartis Investigative Site
state: PZ
city: Ravenna
country: Italy
facility: Novartis Investigative Site
state: RA
city: Reggio Calabria
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facility: Novartis Investigative Site
state: RC
city: Reggio Emilia
country: Italy
facility: Novartis Investigative Site
state: RE
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Nocera Inferiore
country: Italy
facility: Novartis Investigative Site
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facility: Novartis Investigative Site
state: SI
city: Sassari
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facility: Novartis Investigative Site
state: SS
city: Taranto
country: Italy
facility: Novartis Investigative Site
state: TA
city: Orbassano
country: Italy
facility: Novartis Investigative Site
state: TO
city: Torino
country: Italy
facility: Novartis Investigative Site
state: TO
city: Terni
country: Italy
facility: Novartis Investigative Site
state: TR
city: Treviso
country: Italy
facility: Novartis Investigative Site
state: TV
city: Ronciglione
country: Italy
facility: Novartis Investigative Site
state: VT
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Novara
country: Italy
facility: Novartis Investigative Site
city: Perugia
country: Italy
facility: Novartis Investigative Site
city: Riga
country: Latvia
facility: Novartis Investigative Site
state: LV
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
city: Klaipeda
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Amsterdam
country: Netherlands
facility: Novartis Investigative Site
city: Delft
country: Netherlands
facility: Novartis Investigative Site
city: Enschede
country: Netherlands
facility: Novartis Investigative Site
city: Groningen
country: Netherlands
facility: Novartis Investigative Site
city: Nijmegen
country: Netherlands
facility: Novartis Investigative Site
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
city: Zwolle
country: Netherlands
facility: Novartis Investigative Site
city: Bergen
country: Norway
facility: Novartis Investigative Site
city: Oslo
country: Norway
facility: Novartis Investigative Site
city: Stavanger
country: Norway
facility: Novartis Investigative Site
city: Tromsoe
country: Norway
facility: Novartis Investigative Site
city: Trondheim
country: Norway
facility: Novartis Investigative Site
city: Gdansk
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Lublin
country: Poland
facility: Novartis Investigative Site
city: Warsaw
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
state: District 2
city: Iasi
country: Romania
facility: Novartis Investigative Site
state: Jud. Iasi
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Cluj-Napoca
country: Romania
facility: Novartis Investigative Site
city: Timisoara
country: Romania
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Martin
country: Slovakia
facility: Novartis Investigative Site
city: Celje
country: Slovenia
facility: Novartis Investigative Site
city: Ljubljana
country: Slovenia
facility: Novartis Investigative Site
city: Elche
country: Spain
facility: Novartis Investigative Site
state: Alicante
city: Oviedo
country: Spain
facility: Novartis Investigative Site
state: Asturias
city: Santander
country: Spain
facility: Novartis Investigative Site
state: Cantabria
city: Toledo
country: Spain
facility: Novartis Investigative Site
state: Castilla la Mancha
city: Salamanca
country: Spain
facility: Novartis Investigative Site
state: Castilla y Leon
city: Badalona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Tarragona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Terrassa
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: La Coruna
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Orense
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Las Palmas de Gran Canaria
country: Spain
facility: Novartis Investigative Site
state: Las Palmas de G.C
city: Majadahonda
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Pamplona
country: Spain
facility: Novartis Investigative Site
state: Navarra
city: Bilbao
country: Spain
facility: Novartis Investigative Site
state: Pais Vasco
city: San Sebastian
country: Spain
facility: Novartis Investigative Site
state: Pais Vasco
city: La Laguna
country: Spain
facility: Novartis Investigative Site
state: Santa Cruz de Tenerife
city: Baracaldo
country: Spain
facility: Novartis Investigative Site
state: Vizcaya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Murcia
country: Spain
facility: Novartis Investigative Site
city: Zaragoza
country: Spain
facility: Novartis Investigative Site
city: Göteborg
country: Sweden
facility: Novartis Investigative Site
city: Huddinge
country: Sweden
facility: Novartis Investigative Site
city: Linköping
country: Sweden
facility: Novartis Investigative Site
city: Lulea
country: Sweden
facility: Novartis Investigative Site
city: Lund
country: Sweden
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Umeå
country: Sweden
facility: Novartis Investigative Site
city: Uppsala
country: Sweden
facility: Novartis Investigative Site
city: Bern
country: Switzerland
facility: Novartis Investigative Site
city: Chur
country: Switzerland
facility: Novartis Investigative Site
city: Genève
country: Switzerland
facility: Novartis Investigative Site
city: Zurich
country: Switzerland
facility: Novartis Investigative Site
city: Uxbridge
country: United Kingdom
facility: Novartis Investigative Site
state: London
city: Cardiff
country: United Kingdom
facility: Novartis Investigative Site
city: Dudley
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Nottingham
country: United Kingdom
facility: Novartis Investigative Site
city: Oxford
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.