Study Assessing Deep Molecular Response in Adult Patients With CML in Chronic Phase Treated With Nilotinib Firstline.

A Phase IV Single Arm, Multicenter, Open-label Study Assessing Deep Molecular Response in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive CML in Chronic Phase After Two Years of Treatment With Nilotinib 300mg BID

ClinicalTrials.gov Identifier: NCT02546674

Novartis Reference Number: CAMN107ADE20

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The main purpose of this study is evaluation of deep molecular response (MR4.5; BCR-ABL IS < 0.0032%) after 24 months of therapy with nilotinib in newly diagnosed patients with chronic phase CML. Via the use of MR4.5 EUTOS ('European Treatment and Outcome Study for CML') laboratories adequate and reliable molecular monitoring as a key parameter for assessing molecular milestones is fostered. Furthermore this trial aims to investigate early prediction of outcome in newly diagnosed patients with nilotinib by assessing the individual decline of BCR-ABL transcripts. Quality of life will bemeasured via use of the EORTC CML-24 questionnaire.

Condition 
Chronic Myeloid Leukemia
Phase 
Phase 4
Overall status 
Active, not recruiting
Enrollment count 
172 participants
Start date 
Feb 18, 2016
Completion date 
Mar 20, 2021
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Nilotinib
Nilotinib will be prescribed by the investigator according to the patient's medical need.

Eligibility Criteria

Inclusion Criteria:

Patients with newly diagnosed (within 6 months) Philadelphia chromosome positive CML in chronic phase; Patients must be previously untreated for CML with the exception of 6 months treatment with hydroxyurea and a maximum of 6 weeks treatment with imatinib

Exclusion Criteria:

-Known impaired cardiac function like long QT syndrome, history of myocardial infarction or unstable angina in the past 12 months. Patients who are pregnant or breast feeding.

Study Locations

Germany
Novartis Investigative Site
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Mannheim, 68305
Baden-Wuerttemberg
Germany
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Herne, 44625
Nordrhein-Westfalen
Germany
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Luebeck, 23563
Schleswig-holstein
Germany
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Aschaffenburg, 63739
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Germany
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Augsburg, 86179
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Germany
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Bad Mergentheim, 97980
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Germany
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Bad Reichenhall, 83435
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Germany
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Bad Saarow, 15526
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Germany
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Bad Soden, 65812
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Germany
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Bamberg, 96049
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Germany
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Bayreuth, 95445
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Germany
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Berlin, 12351
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Germany
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Berlin, 13353
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Germany
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Berlin, 13357
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Germany
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Berlin, 13581
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Germany
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Berlin, 14195
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Germany
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Biberach, 88400
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Germany
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Bremerhaven, 27568
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Germany
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Chemnitz, 09113
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Germany
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Donauwoerth, 86609
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Germany
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Dresden, 01307
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Germany
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Duesseldorf, 40225
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Germany
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Duesseldorf, 40479
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Germany
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Erfurt, 99085
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Germany
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Essen, 45136
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Germany
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Essen, 45147
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Germany
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Georgsmarienhuette, 49124
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Germany
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Giessen, 35392
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Germany
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Goslar, 38642
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Germany
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Göppingen, 73035
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Germany
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Halberstadt, 38820
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Germany
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Halle S, 06120
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Germany
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Halle, 06110
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Germany
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Hannover, 30161
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Germany
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Hannover, 30170
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Germany
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Heidelberg, 69115
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Germany
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Heidelberg, 69120
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Germany
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Jena, 07740
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Germany
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Kassel, 34125
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Germany
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Kiel, 24105
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Germany
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Koeln, 50671
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Germany
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Leipzig, 04103
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Germany
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Magdeburg, 39104
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Germany
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Memmingen, 87700
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Germany
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Minden, 32429
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Germany
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Moers, 47441
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Germany
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Muelheim, 45468
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Germany
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Muenchen, 80335
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Germany
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Muenster, 48149
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Germany
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Mutlangen, 73557
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Germany
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Nuernberg, 90403
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Germany
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Nuernberg, 90419
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Germany
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Oldenburg, 26121
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Germany
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Paderborn, 33098
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Germany
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Passau, 94036
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Germany
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Potsdam, 14467
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Germany
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Rostock, 18059
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Germany
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Rotenburg, 27356
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Germany
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Saarbruecken, 66113
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Germany
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Schorndorf, 73614
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Germany
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Schweinfurt, 97422
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Germany
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Schwäbisch-Hall, 74523
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Germany
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Tübingen, 72076
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Germany
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Velbert, 42551
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Germany
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Westerstede, 26655
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Germany
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Wiesbaden, 65191
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Germany
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Wilhelmshaven, 26389
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Germany
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Wolfsburg, 38440
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Germany
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Worms, 67547
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Germany
Novartis Investigative Site
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Wuerzburg, 97080
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Germany

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