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

NCT01061177 | Completed Phase 4 Results DMC

• 2 other identifiers: CAMN107EIC012009-017775-19
• Study Type: interventional
• Target: 1,090
• Locations: 24 countries
• Sites: 316

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.

Conditions

CML in Chronic Phase

Keywords

Leukemia; myeloid; myelogenous; chronic BCR-ABL positive; Nilotinib; Philadelphia chromosome; CML in chronic phase

Outcome Measures

Primary Outcomes (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.

  at 18 months

Secondary Outcomes (15)

• Percentage of Participants Free From Progression to Accelerated Phase/Blast Crisis (AP/BC) at 12 and 24 Months

  at 12 and 24 months

• Rate of Event Free Survival at 12 and 24 Months

  at 12 and 24 months

• Percentage of Participants With Major Molecular Response (MMR) at, as Well as by, 12 and 24 Months

  12 months, 24 months

• Percentage of Participants With Complete Cytogenetic Response (CCyR) at, as Well as by, 12 and 24 Months

  12 and 24 months

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

  12 and 24 months

Study Arms (1)

Nilotinib

EXPERIMENTAL

This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.

Drug: Nilotinib

Interventions

Nilotinib DRUG

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.

Also known as: AMN107

Nilotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (320)

Novartis Investigative Site

Wels, Austria, A-4600, Austria

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Novartis Investigative Site

Graz, 8036, Austria

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Novartis Investigative Site

Innsbruck, A-6020, Austria

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Novartis Investigative Site

Linz, 4010, Austria

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Novartis Investigative Site

Rankweil, A-6830, Austria

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Novartis Investigative Site

Salzburg, 5020, Austria

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Novartis Investigative Site

Vienna, A-1130, Austria

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Novartis Investigative Site

Vienna, A-1140, Austria

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Novartis Investigative Site

Aalst, Belgium, 9300, Belgium

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Novartis Investigative Site

Luxembourg, Luxembourg, 1210, Belgium

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Novartis Investigative Site

Bruges, 8000, Belgium

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Novartis Investigative Site

Brussels, 1000, Belgium

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Novartis Investigative Site

Brussels, 1070, Belgium

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Novartis Investigative Site

Brussels, 1090, Belgium

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Novartis Investigative Site

Brussels, BE-B-1200, Belgium

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Novartis Investigative Site

Charleroi, 6000, Belgium

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Novartis Investigative Site

Edegem, 2650, Belgium

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Novartis Investigative Site

Ghent, 9000, Belgium

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Novartis Investigative Site

Hasselt, 3500, Belgium

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Novartis Investigative Site

Laken, 1020, Belgium

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Novartis Investigative Site

Leuven, 3000, Belgium

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Novartis Investigative Site

Roeselare, 8800, Belgium

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Novartis Investigative Site

Verviers, 4800, Belgium

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Novartis Investigative Site

Yvoir, 5530, Belgium

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Novartis Investigative Site

Pleven, Bulgaria, 5800, Bulgaria

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Plovdiv, 4002, Bulgaria

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Novartis Investigative Site

Sofia, 1431, Bulgaria

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Novartis Investigative Site

Sofia, 1756, Bulgaria

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Novartis Investigative Site

Varna, 9000, Bulgaria

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Novartis Investigative Site

Rijeka, 51000, Croatia

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Novartis Investigative Site

Zagreb, 10000, Croatia

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Novartis Investigative Site

Brno-Bohunice, Czech Republic, 625 00, Czechia

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Novartis Investigative Site

Hradec Králové, Czech Republic, 500 05, Czechia

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Novartis Investigative Site

Prague, Czech Republic, 128 20, Czechia

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Novartis Investigative Site

Olomouc, CZE, 775 20, Czechia

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Novartis Investigative Site

Aarhus C, DK-8000, Denmark

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Novartis Investigative Site

Copenhagen, DK-2100, Denmark

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Novartis Investigative Site

Odense C, DK-5000, Denmark

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Novartis Investigative Site

Tartu, 51006, Estonia

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Novartis Investigative Site

HUS Helsinki, FIN-00029, Finland

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Novartis Investigative Site

Oulu, 900114, Finland

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Novartis Investigative Site

Bayonne, Bayonne Cedex, 64109, France

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Novartis Investigative Site

Paris, Cedex 10, 75475, France

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Novartis Investigative Site

Saint-Denis, France / La Reunion, 97405, France

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Novartis Investigative Site

Angers, France, 49033, France

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Novartis Investigative Site

Dunkirk, France, 59240, France

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Novartis Investigative Site

Monte-Carlo, Principauté de Monaco, 98012, France

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Novartis Investigative Site

Aix-en-Provence, 13616, France

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Novartis Investigative Site

Amiens Cedex1, 80054, France

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Novartis Investigative Site

Argenteuil, 95107, France

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Novartis Investigative Site

Avignon, 84902, France

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Novartis Investigative Site

Besançon, 25030, France

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Novartis Investigative Site

Blois, 41016, France

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Bordeaux, 33076, France

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Novartis Investigative Site

Brest, 29200, France

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Novartis Investigative Site

Caen, 14000, France

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Novartis Investigative Site

Chalon-sur-Saône, 71321, France

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Novartis Investigative Site

Chambéry, 73011, France

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Novartis Investigative Site

Clermont-Ferrand, 63003, France

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Novartis Investigative Site

Compiègne, 60321, France

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Novartis Investigative Site

Corbeil-Essonnes, 91100, France

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Novartis Investigative Site

Créteil, 94010, France

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Novartis Investigative Site

Dijon, 21034, France

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Novartis Investigative Site

Grenoble, 38043, France

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Novartis Investigative Site

La Roche-sur-Yon, 85925, France

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Novartis Investigative Site

Le Chesnay, 78157, France

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Novartis Investigative Site

Le Coudray, 28630, France

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Novartis Investigative Site

Le Mans, 72037, France

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Novartis Investigative Site

Lens, 62307, France

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Lille, 59020, France

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Limoges, 87042, France

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Marseille, 13273, France

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Marseille, 13915, France

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Mâcon, 71018, France

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Metz, 57038, France

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Novartis Investigative Site

Montfermeil, 93370, France

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Montpellier, 34295, France

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Mulhouse, 68070, France

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Nantes, 44035, France

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Nice, 06189, France

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Nîmes, 32900, France

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Paris, 75012, France

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Novartis Investigative Site

Pau, 64000, France

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Perpignan, 66046, France

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Pringy, 74374, France

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Reims, 51092, France

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Rennes, 35019, France

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Roubaix, 59100, France

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Rouen, 76038, France

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Saint-Brieuc, 22027, France

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Saint-Priest-en-Jarez, 42271, France

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Saint-Quentin, 02321, France

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Strasbourg, 67085, France

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Strasbourg, 67091, France

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Toulouse, 31059, France

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Novartis Investigative Site

Tours, 37044, France

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Novartis Investigative Site

Troyes, 10003, France

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Novartis Investigative Site

Eschweiler, Germany, 52249, Germany

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Novartis Investigative Site

Kiel, Germany, 24116, Germany

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Mainz, Germany, 55131, Germany

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Cologne, North Rhine-Westphalia, 50937, Germany

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Aachen, 52074, Germany

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Aschaffenburg, 63739, Germany

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Augsburg, 86156, Germany

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Bamberg, 96049, Germany

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Bayreuth, 95445, Germany

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Berlin, 10707, Germany

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Berlin, 10709, Germany

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Berlin, 13353, Germany

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Berlin, 14195, Germany

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Bielefeld, 33604, Germany

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Bonn, 53105, Germany

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Bottrop, 46236, Germany

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Bremen, 28177, Germany

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Dresden, 01307, Germany

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Duisburg, 47166, Germany

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Düsseldorf, 40225, Germany

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Eisenach, 99817, Germany

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Essen, 45136, Germany

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Essen, 45147, Germany

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Frankfurt, 60590, Germany

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Novartis Investigative Site

Frankfurt, 60596, Germany

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Frankfurt (Oder), 15236, Germany

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Freiburg im Breisgau, 79106, Germany

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Fulda, 36043, Germany

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Novartis Investigative Site

Giessen, 35392, Germany

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Goslar, 38642, Germany

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Greifswald, 17475, Germany

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Hagen, 58097, Germany

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Hamburg, 20246, Germany

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Novartis Investigative Site

Hamm, 59063, Germany

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Novartis Investigative Site

Hanover, 30170, Germany

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Novartis Investigative Site

Hanover, 30625, Germany

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Novartis Investigative Site

Herrsching am Ammersee, 82211, Germany

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Hildesheim, 31134, Germany

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Novartis Investigative Site

Jena, 07740, Germany

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Novartis Investigative Site

Karlsruhe, 76133, Germany

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Novartis Investigative Site

Karlsruhe, 76135, Germany

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Novartis Investigative Site

Kassel, 34119, Germany

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Kassel, 34125, Germany

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Koblenz, 56068, Germany

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Landshut, 84028, Germany

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Leipzig, 04103, Germany

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Lemgo, 32657, Germany

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Lübeck, 23563, Germany

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Magdeburg, 39104, Germany

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Mannheim, 68169, Germany

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Marburg, 35039, Germany

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Moers, 47441, Germany

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Mönchengladbach, 41063, Germany

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Mutlangen, 73557, Germany

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Mülheim, 45468, Germany

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München, 80335, Germany

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München, 81241, Germany

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Novartis Investigative Site

München, 81675, Germany

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Novartis Investigative Site

München, 81737, Germany

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Novartis Investigative Site

Münster, 48149, Germany

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Neunkirchen, 66538, Germany

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Nuremberg, 90419, Germany

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Nuremberg, 90449, Germany

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Offenburg, 77652, Germany

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Paderborn, 33102, Germany

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Ravensburg, 88214, Germany

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Novartis Investigative Site

Rostock, 18057, Germany

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Novartis Investigative Site

Schorndorf, 73614, Germany

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Novartis Investigative Site

Schwäbisch Hall, 74523, Germany

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Novartis Investigative Site

Sindelfingen, 71065, Germany

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Novartis Investigative Site

Stuttgart, 70376, Germany

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Novartis Investigative Site

Traunstein, 83278, Germany

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Novartis Investigative Site

Triberg, 78098, Germany

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Ulm, 89081, Germany

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Novartis Investigative Site

Velbert, 42551, Germany

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Viersen, 45468, Germany

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Weilheim, 82362, Germany

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Wendlingen, 73240, Germany

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Würzburg, 97080, Germany

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Zella-Mehlis, 98544, Germany

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Novartis Investigative Site

Alexandroupoli, Evros, 68100, Greece

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Novartis Investigative Site

Athens, Greece, 11527, Greece

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Novartis Investigative Site

Heraklion Crete, Greece, 711 10, Greece

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Novartis Investigative Site

Pátrai, Greece, 265 00, Greece

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Novartis Investigative Site

Athens, GR, 115 27, Greece

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Novartis Investigative Site

Larissa, GR, 411 10, Greece

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Novartis Investigative Site

Thessaloniki, GR, 546 42, Greece

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Novartis Investigative Site

Budapest, 1097, Hungary

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Novartis Investigative Site

Debrecen, 4032, Hungary

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Novartis Investigative Site

Kaposvár, 7400, Hungary

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Novartis Investigative Site

Pécs, 7624, Hungary

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Novartis Investigative Site

Szeged, H-6725, Hungary

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Novartis Investigative Site

Ancona, AN, 60126, Italy

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Novartis Investigative Site

Avellino, AV, 83100, Italy

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Novartis Investigative Site

Bari, BA, 70124, Italy

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Novartis Investigative Site

Bologna, BO, 40138, Italy

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Brindisi, BR, 72100, Italy

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Novartis Investigative Site

Brescia, BS, 25123, Italy

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Novartis Investigative Site

Cagliari, CA, 09121, Italy

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Novartis Investigative Site

Cagliari, CA, 09126, Italy

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Cuneo, CN, 12100, Italy

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Novartis Investigative Site

Rossano, CS, 87067, Italy

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Novartis Investigative Site

Catanzaro, CZ, 88100, Italy

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Novartis Investigative Site

Cona, FE, 44100, Italy

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Novartis Investigative Site

San Giovanni Rotondo, FG, 71013, Italy

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Novartis Investigative Site

Florence, FI, 50134, Italy

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Novartis Investigative Site

Genova, GE, 16132, Italy

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Novartis Investigative Site

Rome, Lazio, 00168, Italy

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Novartis Investigative Site

Lecce, LE, 73100, Italy

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Livorno, LI, 57124, Italy

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Milan, MI, 20122, Italy

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Milan, MI, 20162, Italy

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Modena, MO, 41100, Italy

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Nuoro, NU, 08100, Italy

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Palermo, PA, 90146, Italy

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Padua, PD, 35128, Italy

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Pescara, PE, 65124, Italy

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Pisa, PI, 56126, Italy

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Pesaro, PU, 61100, Italy

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Pavia, PV, 27100, Italy

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Potenza, PZ, 85100, Italy

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Ravenna, RA, 48100, Italy

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Reggio Calabria, RC, 89124, Italy

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Reggio Emilia, RE, 42123, Italy

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Roma, RM, 00144, Italy

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Roma, RM, 00161, Italy

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Nocera Inferiore, SA, 84014, Italy

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Siena, SI, 53100, Italy

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Sassari, SS, 07100, Italy

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Taranto, TA, 74100, Italy

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Orbassano, TO, 10043, Italy

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Torino, TO, 10126, Italy

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Terni, TR, 05100, Italy

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Treviso, TV, 31100, Italy

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Ronciglione, VT, 01100, Italy

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Napoli, 80131, Italy

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Napoli, 80132, Italy

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Novara, 28100, Italy

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Perugia, 06129, Italy

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Riga, LV, 1006, Latvia

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Kaunas, 3007, Lithuania

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Klaipėda, LT-92231, Lithuania

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Vilnius, LT-08661, Lithuania

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Amsterdam, 1081 HV, Netherlands

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Delft, 2625 AD, Netherlands

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Novartis Investigative Site

Enschede, 7513 ER, Netherlands

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Groningen, 9713 GZ, Netherlands

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Nijmegen, 6525 GA, Netherlands

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Rotterdam, 3075 EA, Netherlands

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Zwolle, 8025 AB, Netherlands

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Novartis Investigative Site

Bergen, NO-5021, Norway

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Oslo, NO-0310, Norway

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Stavanger, 4068, Norway

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Tromsø, NO-9038, Norway

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Trondheim, 7006, Norway

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Warsaw, Poland, 02-106, Poland

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Gdansk, 80-952, Poland

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Krakow, 30-510, Poland

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Lublin, 20-081, Poland

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Warsaw, 02-776, Poland

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Wroclaw, 50-367, Poland

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Lisbon, Portugal, 1150-314, Portugal

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Porto, Portugal, 4200319, Portugal

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Porto, 4200-072, Portugal

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Bucharest, District 2, 022328, Romania

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Iași, Jud. Iasi, 700111, Romania

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Bucharest, Romania, 030171, Romania

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Timișoara, Romania, 300 079, Romania

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Bucharest, 050098, Romania

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Cluj-Napoca, 3400, Romania

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Košice, Slovak Republic, 04066, Slovakia

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Novartis Investigative Site

Martin, Slovakia, 03601, Slovakia

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Bratislava, 851 07, Slovakia

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Novartis Investigative Site

Celje, 3000, Slovenia

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Novartis Investigative Site

Ljubljana, 1000, Slovenia

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Novartis Investigative Site

Elche, Alicante, 03203, Spain

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Novartis Investigative Site

Barcelona, Barcelona, 08041, Spain

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Bilbao, Basque Country, 48013, Spain

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Donostia / San Sebastian, Basque Country, 20080, Spain

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Santander, Cantabria, 39008, Spain

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Salamanca, Castille and León, 37007, Spain

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Toledo, Castille-La Mancha, 45071, Spain

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Badalona, Catalonia, 08916, Spain

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Novartis Investigative Site

Barcelona, Catalonia, 08003, Spain

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Barcelona, Catalonia, 08035, Spain

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Novartis Investigative Site

Barcelona, Catalonia, 08036, Spain

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Novartis Investigative Site

Tarragona, Catalonia, 43005, Spain

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Novartis Investigative Site

Terrassa, Catalonia, 08221, Spain

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A Coruña, Galicia, 15006, Spain

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Ourense, Galicia, 32005, Spain

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Novartis Investigative Site

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

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Novartis Investigative Site

Madrid, Madrid, 28006, Spain

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Novartis Investigative Site

Madrid, Madrid, 28034, Spain

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Novartis Investigative Site

Madrid, Madrid, 28040, Spain

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Novartis Investigative Site

Madrid, Madrid, 28041, Spain

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Novartis Investigative Site

Madrid, Madrid, 28046, Spain

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Majadahonda, Madrid, 28222, Spain

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Murcia, Murcia, 30008, Spain

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Pamplona, Navarre, 31008, Spain

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Oviedo, Principality of Asturias, 33006, Spain

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

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Valencia, Valencia, 46010, Spain

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Novartis Investigative Site

Barakaldo, Vizcaya, 48903, Spain

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Zaragoza, Zaragoza, 50009, Spain

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Novartis Investigative Site

Gothenburg, SE-413 45, Sweden

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Novartis Investigative Site

Huddinge, SE-14186, Sweden

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Linköping, SE-581 85, Sweden

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Novartis Investigative Site

Luleå, SE-971 80, Sweden

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Novartis Investigative Site

Lund, SE-221 85, Sweden

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Novartis Investigative Site

Stockholm, SE-171 76, Sweden

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Novartis Investigative Site

Umeå, SE-901 85, Sweden

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Novartis Investigative Site

Uppsala, SE-751 85, Sweden

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Novartis Investigative Site

Zurich, Switzerland, 8091, Switzerland

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Novartis Investigative Site

Bern, 3010, Switzerland

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Novartis Investigative Site

Chur, 7000, Switzerland

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Novartis Investigative Site

Geneva, 1211, Switzerland

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Novartis Investigative Site

Uxbridge, London, UB8 3NN, United Kingdom

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Novartis Investigative Site

Cardiff, CF14 4XW, United Kingdom

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Novartis Investigative Site

Dudley, DY1 2HQ, United Kingdom

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Novartis Investigative Site

London, SE5 9RS, United Kingdom

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Novartis Investigative Site

London, W12 0HS, United Kingdom

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Novartis Investigative Site

Nottingham, NG5, United Kingdom

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Novartis Investigative Site

Oxford, OX3 7LJ, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 28522574 DERIVED

• 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.

  PMID: 27006491 DERIVED

MeSH Terms

Conditions

Leukemia; Philadelphia Chromosome

Interventions

nilotinib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Translocation, Genetic; Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

trialandresults.registry@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2010
• First Posted: February 2, 2010
• Study Start: May 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: February 24, 2017
• Results First Posted: February 24, 2017

Record last verified: 2016-12

Locations

DE (80); HU (5); FR (56); PL (6); BU (5); LA (1); ES (29); BE (16); RO (6); SL (2); CH (4); NL (7); PT (3); CZ (4); SE (8); LI (3); FI (2); CR (2); GR (7); AU (8); IT (47); GB (7); NO (5); DK (3)