Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome & /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase
NCT ID: NCT01061177
Last Updated: 2017-02-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1090 participants
INTERVENTIONAL
2010-05-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nilotinib
This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Klaipėda, , Lithuania
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Vilnius, , Lithuania
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Amsterdam, , Netherlands
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Delft, , Netherlands
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Enschede, , Netherlands
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Groningen, , Netherlands
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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Zwolle, , Netherlands
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Bergen, , Norway
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Oslo, , Norway
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Stavanger, , Norway
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Tromsø, , Norway
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Trondheim, , Norway
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Warsaw, Poland, Poland
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Gdansk, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Lisbon, Portugal, Portugal
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Porto, Portugal, Portugal
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Porto, , Portugal
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Bucharest, District 2, Romania
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Iași, Jud. Iasi, Romania
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Bucharest, Romania, Romania
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Wels, Austria, Austria
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Graz, , Austria
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Innsbruck, , Austria
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Linz, , Austria
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Rankweil, , Austria
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Salzburg, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Aalst, Belgium, Belgium
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Luxembourg, Luxembourg, Belgium
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Bruges, , Belgium
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Brussels, , Belgium
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Charleroi, , Belgium
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Edegem, , Belgium
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Ghent, , Belgium
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Hasselt, , Belgium
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Laken, , Belgium
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Leuven, , Belgium
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Roeselare, , Belgium
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Verviers, , Belgium
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Yvoir, , Belgium
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Pleven, Bulgaria, Bulgaria
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Rijeka, , Croatia
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Zagreb, , Croatia
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Brno - Bohunice, Czech Republic, Czechia
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Hradec Králové, Czech Republic, Czechia
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Prague, Czech Republic, Czechia
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Olomouc, CZE, Czechia
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Aarhus C, , Denmark
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Odense C, , Denmark
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Tartu, , Estonia
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HUS Helsinki, , Finland
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Oulu, , Finland
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Bayonne, Bayonne Cedex, France
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Paris, Cedex 10, France
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Saint-Denis, France / La Reunion, France
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Angers, France, France
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Dunkirk, France, France
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Monte-Carlo, Principauté de Monaco, France
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Aix-en-Provence, , France
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Amiens Cedex1, , France
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Leipzig, , Germany
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Lübeck, , Germany
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Mannheim, , Germany
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Moers, , Germany
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Mönchengladbach, , Germany
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Mutlangen, , Germany
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Mülheim, , Germany
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München, , Germany
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München, , Germany
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München, , Germany
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Münster, , Germany
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Neunkirchen, , Germany
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Nuremberg, , Germany
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Offenburg, , Germany
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Paderborn, , Germany
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Zella-Mehlis, , Germany
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Alexandroupoli, Evros, Greece
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Athens, Greece, Greece
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Heraklion Crete, Greece, Greece
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Pátrai, Greece, Greece
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Athens, GR, Greece
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Larissa, GR, Greece
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Thessaloniki, GR, Greece
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Budapest, , Hungary
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Debrecen, , Hungary
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Kaposvár, , Hungary
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Pécs, , Hungary
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Szeged, , Hungary
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Ancona, AN, Italy
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Bologna, BO, Italy
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Livorno, LI, Italy
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Nuoro, NU, Italy
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Palermo, PA, Italy
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Padua, PD, Italy
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Pescara, PE, Italy
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Pisa, PI, Italy
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Pesaro, PU, Italy
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Pavia, PV, Italy
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Potenza, PZ, Italy
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Ravenna, RA, Italy
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Reggio Calabria, RC, Italy
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Reggio Emilia, RE, Italy
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Roma, RM, Italy
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Roma, RM, Italy
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Nocera Inferiore, SA, Italy
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Siena, SI, Italy
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Treviso, TV, Italy
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Ronciglione, VT, Italy
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Napoli, , Italy
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Napoli, , Italy
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Novara, , Italy
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Perugia, , Italy
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Riga, LV, Latvia
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Kaunas, , Lithuania
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Timișoara, Romania, Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Košice, Slovak Republic, Slovakia
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Martin, Slovakia, Slovakia
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Bratislava, , Slovakia
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Celje, , Slovenia
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Ljubljana, , Slovenia
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Elche, Alicante, Spain
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Majadahonda, Madrid, Spain
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Barakaldo, Vizcaya, Spain
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Zaragoza, Zaragoza, Spain
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Gothenburg, , Sweden
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Huddinge, , Sweden
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Linköping, , Sweden
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Luleå, , Sweden
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Lund, , Sweden
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Stockholm, , Sweden
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Umeå, , Sweden
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Uppsala, , Sweden
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Zurich, Switzerland, Switzerland
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Bern, , Switzerland
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Chur, , Switzerland
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Geneva, , Switzerland
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Uxbridge, London, United Kingdom
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Cardiff, , United Kingdom
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Dudley, , United Kingdom
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London, , United Kingdom
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Nottingham, , United Kingdom
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Oxford, , United Kingdom
Countries
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References
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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.
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.
Other Identifiers
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2009-017775-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAMN107EIC01
Identifier Type: -
Identifier Source: org_study_id
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