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

PHASE3CompletedINTERVENTIONAL
Enrollment

620

Participants

Timeline

Start Date

April 15, 2013

Primary Completion Date

July 8, 2020

Study Completion Date

July 8, 2020

Conditions
Philadelphia Chromosome Positive (PH+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Interventions
DRUG

Nilotinib

Participants received a daily oral nilotinib dose of 300 mg BID, given as two 150 mg capsules BID.

Trial Locations (208)

1000

Novartis Investigative Site, Ljubljana

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Novartis Investigative Site, Brussels

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Novartis Investigative Site, Budapest

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Novartis Investigative Site, Sofia

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Novartis Investigative Site, Iași

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Novartis Investigative Site, Thessaloniki

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Novartis Investigative Site, Pátrai

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Novartis Investigative Site, Warsaw

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Novartis Investigative Site, Lisbon

1749-035

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Novartis Investigative Site, Timișoara

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Novartis Investigative Site, Martin

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Novartis Investigative Site, Palma de Mallorca

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Novartis Investigative Site, L'Hospitalet de Llobregat

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Novartis Investigative Site, Granollers

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Novartis Investigative Site, Stockholm

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Novartis Investigative Site, East Yorkshire

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Novartis Investigative Site, Edinburgh

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Novartis Investigative Site, London

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Novartis Investigative Site, London

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY