Last updated on July 2018

A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML.


Brief description of study

This study aims to assess the optimal duration of nilotinib 300 mg BID consolidation treatment, in order that patients remain in treatment-free remission (MR4.0) 12 months after starting the Treatment-Free Remission (TFR) phase of the study.

Rationale

CP-CML patients who have received 2 or more calendar years of first-line imatinib treatment, and who have failed to achieve the molecular response threshold for treatment cessation (MR4.0) have a 50% greater chance of doing by switching to nilotinib; however the optimal duration of consolidation treatment with nilotinib to ensure the highest rate of patients remaining in MR4.0 after entering the TFR phase is not yet known. This protocol therefore aims to assess the potential impact of a longer duration of consolidation treatment with nilotinib, i.e. 12 months versus 24 months, on molecular relapse rate in the first 12 months of treatment-free remission.

Clinical Study Identifier: NCT01743989

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Novartis Investigative Site

Haine-saint-Paul, Belgium
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Hradec Kralove, Czech Republic
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Brno - Bohunice, Czech Republic
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Brive la Gaillard, France
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Clermont Ferrand cedex 1, France
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La Roche sur Yon cedex 9, France
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Le Kremlin Bicetre, France
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Montpellier cedex 5, France
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Pierre-Benite Cedex, France
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Vandoeuvre Les Nancy, France
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San Giovanni Rotondo, Italy
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Hospitalet de LLobregat, Spain
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Santiago de Compostela, Spain
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Santa Cruz de Tenerife, Spain
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East Yorkshire, United Kingdom
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Edinburgh, United Kingdom
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Manchester, United Kingdom
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Brive La Gaillard, France
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Saint Priest en Jarez, France
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Chalon sur Saône, France
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Marseille Cédex 5, France
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Bad Homburg vor der Höhe, Germany
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Georgsmarienhütte, Germany
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Schwäbisch-Hall, Germany
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Recruitment Status: Open


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