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

Last updated: March 21, 2022
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

4

Condition

Leukemia

Chronic Myeloid Leukemia

Platelet Disorders

Treatment

N/A

Clinical Study ID

NCT02546674
CAMN107ADE20
2015-000968-34
  • Ages 18-120
  • All Genders

Study Summary

The main purpose of this study was to evaluate the rate of deep molecular response (MR4.5) after 24 months of therapy with nilotinib in newly diagnosed patients with chronic phase chronic myeloid leukemia (CML) using EUTOS (European Treatment and Outcome Study for CML)-standardized laboratories. All participants received nilotinib 300 mg twice daily (BID).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Patients with newly diagnosed (within 6 months) Philadelphia chromosome positive CMLin chronic phase
  • Patients must be previously untreated for CML with the exception of 6 months treatmentwith hydroxyurea and a maximum of 6 weeks treatment with imatinib
  • Adequate end organ function
  • Normal serum levels ≥ lower limit of normal (LLN) of potassium, magnesium, totalcalcium corrected for serum albumin or phosphorus, or correctable to within normallimits with supplements, prior to the first dose of study medication.

Exclusion

Key Exclusion Criteria:

  • Known impaired cardiac function like long QT syndrome, history of myocardialinfarction or unstable angina in the past 12 months.
  • Patients who are pregnant or breast feeding. Other inclusion/exclusion criteria might apply

Study Design

Total Participants: 171
Study Start date:
February 18, 2016
Estimated Completion Date:
March 25, 2021

Study Description

This was a Phase IV open-label, multi-center, single-arm study in participants with newly diagnosed Philadelphia chromosome positive (Ph+) CML in chronic phase for who nilotinib is the appropriate treatment at the discretion of the investigator.

A screening period of 2 weeks was used to assess eligibility and to taper participants off disallowed medications. Participants whose eligibility was confirmed entered a 24 months treatment phase with nilotinib 300mg BID. Nilotinib was prescribed by the investigator according to the individual needs of the participants.

Connect with a study center

  • Novartis Investigative Site

    Heidenheim, Baden-Wuerttemberg 89518
    Germany

    Site Not Available

  • Novartis Investigative Site

    Mannheim, Baden-Wuerttemberg 68305
    Germany

    Site Not Available

  • Novartis Investigative Site

    Herne, Nordrhein-Westfalen 44625
    Germany

    Site Not Available

  • Novartis Investigative Site

    Luebeck, Schleswig-holstein 23563
    Germany

    Site Not Available

  • Novartis Investigative Site

    Aschaffenburg, 63739
    Germany

    Site Not Available

  • Novartis Investigative Site

    Augsburg, 86179
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bad Liebenwerda, 04924
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bad Mergentheim, 97980
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bad Reichenhall, 83435
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bad Saarow, 15526
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bad Soden, 65812
    Germany

    Site Not Available

  • Novartis Investigative Site

    Baden-Baden, 76532
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bamberg, 96049
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bayreuth, 95445
    Germany

    Site Not Available

  • Novartis Investigative Site

    Berlin, 13581
    Germany

    Site Not Available

  • Novartis Investigative Site

    Biberach, 88400
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bremerhaven, 27568
    Germany

    Site Not Available

  • Novartis Investigative Site

    Chemnitz, 09113
    Germany

    Site Not Available

  • Novartis Investigative Site

    Deggendorf, 94469
    Germany

    Site Not Available

  • Novartis Investigative Site

    Donauwoerth, 86609
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dortmund, 44263
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dresden, 01307
    Germany

    Site Not Available

  • Novartis Investigative Site

    Duesseldorf, 40479
    Germany

    Site Not Available

  • Novartis Investigative Site

    Erfurt, 99085
    Germany

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  • Novartis Investigative Site

    Eschweiler, 52249
    Germany

    Site Not Available

  • Novartis Investigative Site

    Essen, 45136
    Germany

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  • Novartis Investigative Site

    Frankfurt, 60389
    Germany

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  • Novartis Investigative Site

    Georgsmarienhuette, 49124
    Germany

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  • Novartis Investigative Site

    Georgsmarienhütte, 49124
    Germany

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  • Novartis Investigative Site

    Gera, 07548
    Germany

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  • Novartis Investigative Site

    Giessen, 35392
    Germany

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  • Novartis Investigative Site

    Goslar, 38642
    Germany

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  • Novartis Investigative Site

    Göppingen, 73035
    Germany

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  • Novartis Investigative Site

    Halberstadt, 38820
    Germany

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  • Novartis Investigative Site

    Halle, 06110
    Germany

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    Halle S, 06120
    Germany

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    Hannover, 30161
    Germany

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  • Novartis Investigative Site

    Heidelberg, 69115
    Germany

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  • Novartis Investigative Site

    Heilbronn, 74072
    Germany

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  • Novartis Investigative Site

    Hof, 95028
    Germany

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  • Novartis Investigative Site

    Jena, 07740
    Germany

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  • Novartis Investigative Site

    Kassel, 34125
    Germany

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  • Novartis Investigative Site

    Kiel, 24105
    Germany

    Site Not Available

  • Novartis Investigative Site

    Koeln, 50671
    Germany

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  • Novartis Investigative Site

    Leipzig, 04103
    Germany

    Site Not Available

  • Novartis Investigative Site

    Lemgo, 32657
    Germany

    Site Not Available

  • Novartis Investigative Site

    Magdeburg, 39104
    Germany

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  • Novartis Investigative Site

    Memmingen, 87700
    Germany

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  • Novartis Investigative Site

    Minden, 32429
    Germany

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  • Novartis Investigative Site

    Moers, 47441
    Germany

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  • Novartis Investigative Site

    Muelheim, 45468
    Germany

    Site Not Available

  • Novartis Investigative Site

    Muenchen, 80335
    Germany

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  • Novartis Investigative Site

    Muenster, 48149
    Germany

    Site Not Available

  • Novartis Investigative Site

    Mutlangen, 73557
    Germany

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  • Novartis Investigative Site

    Naunhof, 04683
    Germany

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  • Novartis Investigative Site

    Nordhorn, 48527
    Germany

    Site Not Available

  • Novartis Investigative Site

    Nuernberg, 90403
    Germany

    Site Not Available

  • Novartis Investigative Site

    Offenburg, 77654
    Germany

    Site Not Available

  • Novartis Investigative Site

    Oldenburg, 26121
    Germany

    Site Not Available

  • Novartis Investigative Site

    Paderborn, 33098
    Germany

    Site Not Available

  • Novartis Investigative Site

    Passau, 94036
    Germany

    Site Not Available

  • Novartis Investigative Site

    Potsdam, 14467
    Germany

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  • Novartis Investigative Site

    Rostock, 18059
    Germany

    Site Not Available

  • Novartis Investigative Site

    Rotenburg, 27356
    Germany

    Site Not Available

  • Novartis Investigative Site

    Saarbruecken, 66113
    Germany

    Site Not Available

  • Novartis Investigative Site

    Saarbrücken, 66113
    Germany

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  • Novartis Investigative Site

    Schorndorf, 73614
    Germany

    Site Not Available

  • Novartis Investigative Site

    Schweinfurt, 97422
    Germany

    Site Not Available

  • Novartis Investigative Site

    Schwäbisch-Hall, 74523
    Germany

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  • Novartis Investigative Site

    Stolberg, 52222
    Germany

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  • Novartis Investigative Site

    Stuttgart, 70376
    Germany

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  • Novartis Investigative Site

    Tübingen, 72076
    Germany

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  • Novartis Investigative Site

    Velbert, 42551
    Germany

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  • Novartis Investigative Site

    Villingen-Schwenningen, 78052
    Germany

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  • Novartis Investigative Site

    Weiden, 92637
    Germany

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  • Novartis Investigative Site

    Westerstede, 26655
    Germany

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  • Novartis Investigative Site

    Wiesbaden, 65191
    Germany

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  • Novartis Investigative Site

    Wilhelmshaven, 26389
    Germany

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  • Novartis Investigative Site

    Wolfsburg, 38440
    Germany

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  • Novartis Investigative Site

    Worms, 67547
    Germany

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  • Novartis Investigative Site

    Wuerselen, 52146
    Germany

    Site Not Available

  • Novartis Investigative Site

    Wuerzburg, 97080
    Germany

    Site Not Available

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