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Nilotinib for Patients With Chronic Myeloid Leukemia in First Line and Any Subsequent Line

NCT ID: NCT05734053

Last Updated: 2023-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

222 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-28

Study Completion Date

2022-09-08

Brief Summary

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This was a non-interventional observational study within the routine chronic myeloid leukemia treatment practice; no further tests were required apart from the assessments routinely performed for Chronic myeloid leukemia patients treated with nilotinib.

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Detailed Description

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The observation period per patient was 24 months. All patients were treated with nilotinib in accordance to the clinical routine at the respective institution and the summary of product characteristics (SmPC).

The observation intervals (documentation at baseline and at about 3, 6, 9, 12, 18 and 24 months) were not fixed and were aligned with the regular treatment schedule and the clinical symptoms of each patient. The medical decision about the schedule as well as therapeutic and diagnostic measures was made solely by the responsible physician. Patients who discontinued treatment within two years of the observation period were followed until starting a new TKI therapy line, however with a maximum time period of six months. All other patients that reached the official end of treatment after completion of the 24-month observation period were followed up for 28 days.

Conditions

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Chronic Myeloid Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Nilotinib

patients prescribed with nilotinib in routine medical practice

Nilotinib

Intervention Type OTHER

There was no treatment allocation. Patients administered Nilotinib by prescription could be enrolled.

Interventions

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Nilotinib

There was no treatment allocation. Patients administered Nilotinib by prescription could be enrolled.

Intervention Type OTHER

Other Intervention Names

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Tasigna

Eligibility Criteria

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Inclusion Criteria

* Adult patients diagnosed with Ph+ CML (or evidence of BCR-ABL transcript) treated with nilotinib under routine medical practice and the SmPC, as amended, in first or any subsequent line, if the current therapy with nilotinib has not been in place for more than twelve months. Retrospective documentation of patients for up to one year will be permitted.
* Patients who have already had an interruption/discontinuation of nilotinib therapy.
* Patients who have been informed about this NIS and have personally dated and signed their informed consent form.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Freudenstadt, Baden-Wurttemberg, Germany

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Aschaffenburg, Bavaria, Germany

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Augsburg, Bavaria, Germany

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Bayreuth, Bavaria, Germany

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Coburg, Bavaria, Germany

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Donauwörth, Bavaria, Germany

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Kronach, Bavaria, Germany

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Landshut, Bavaria, Germany

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Munich, Bavaria, Germany

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Frankfurt (Oder), Brandenburg, Germany

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Baden-Württemberg, Heidenheim a.d.B, Germany

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Erbach im Odenwald, Hesse, Germany

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Goslar, Lower Saxony, Germany

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Göttingen, Lower Saxony, Germany

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Hanover, Lower Saxony, Germany

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Twistringen, Lower Saxony, Germany

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Westerstede, Lower Saxony, Germany

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Aachen, North Rhine-Westphalia, Germany

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Neuss, North Rhine-Westphalia, Germany

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Ahaus, Northrhine Westfalia, Germany

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Bad Salzuflen, Northrhine Westfalia, Germany

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Hagen, Northrhine Westfalia, Germany

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Iserlohn, Northrhine Westfalia, Germany

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Neuwied, Rhineland-Palatinate, Germany

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Bad Schlema, Saxony, Germany

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Dresden, Saxony, Germany

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Zittau, Saxony, Germany

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Reinbek, Schleswig-Holstein, Germany

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Altötting, , Germany

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Bad Liebenwerda, , Germany

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Bad Mergentheim, , Germany

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Bamberg, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Biberach, , Germany

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Bielefeld, , Germany

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Cologne, , Germany

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Erfurt, , Germany

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Erfurt, , Germany

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Frankfurt, , Germany

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Frankfurt, , Germany

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Gera, , Germany

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Halberstadt, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Hamelin, , Germany

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Hamm, , Germany

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Hanover, , Germany

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Heilbronn, , Germany

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Heilbronn, , Germany

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Hildesheim, , Germany

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Lemgo, , Germany

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Ludwigsburg, , Germany

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Memmingen, , Germany

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Merseburg, , Germany

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Moers, , Germany

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München, , Germany

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Neumünster, , Germany

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Nordhorn, , Germany

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Nuremberg, , Germany

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Nuremberg, , Germany

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Offenburg, , Germany

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Osnabrück, , Germany

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Porta Westfalica, , Germany

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Potsdam, , Germany

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Rotenburg (Wümme), , Germany

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Rüsselsheim am Main, , Germany

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Schorndorf, , Germany

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Singen, , Germany

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Speyer, , Germany

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Stolberg, , Germany

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Viersen, , Germany

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Wiesbaden, , Germany

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Wilhelmshaven, , Germany

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Wolfsburg, , Germany

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Würzburg, , Germany

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Countries

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Germany

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=18084

Results for Study CAMN107ADE23 that is getting linked from the Novartis Clinical Trials Website

Other Identifiers

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CAMN107ADE23

Identifier Type: -

Identifier Source: org_study_id

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