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

Plain-language summary

This study assesses the deep molecular response achieved with first-line Nilotinib in adult patients with chronic-phase chronic myeloid leukemia (CML). Adults with newly diagnosed, Philadelphia chromosome-positive chronic-phase CML who have not previously been treated for CML may take part. The study was conducted in Phase 4 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 4

Status

Completed

Sponsor

Novartis Pharmaceuticals

Intervention

Nilotinib

Start date

2/18/2016

Estimated completion

3/25/2021

Countries

Germany

Related genes

Locations

• Mannheim, Germany
• Herne, Germany
• Lübeck, Germany
• Aschaffenburg, Germany
• Augsburg, Germany
• Bad Mergentheim, Germany
• Bad Reichenhall, Germany
• Bad Saarow, Germany
• Bad Soden, Germany
• Bamberg, Germany
• Bayreuth, Germany
• Berlin, Germany
• Berlin, Germany
• Berlin, Germany
• Berlin, Germany
• Berlin, Germany
• Biberach, Germany
• Bremerhaven, Germany
• Chemnitz, Germany
• Cologne, Germany
• Donauwörth, Germany
• Dresden, Germany
• Düsseldorf, Germany
• Düsseldorf, Germany
• Erfurt, Germany
• Essen, Germany
• Essen, Germany
• Georgsmarienhütte, Germany
• Giessen, Germany
• Goslar, Germany
• Göppingen, Germany
• Halberstadt, Germany
• Halle, Germany
• Halle S, Germany
• Hanover, Germany
• Hanover, Germany
• Heidelberg, Germany
• Heidelberg, Germany
• Jena, Germany
• Kassel, Germany

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Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Key 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
* Adequate end organ function
* Normal serum levels ≥ lower limit of normal (LLN) of potassium, magnesium, total calcium corrected for serum albumin or phosphorus, or correctable to within normal limits with supplements, prior to the first dose of study medication.

Key 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.

Other inclusion/exclusion criteria might apply