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

NCT05734053 | Completed

• 1 other identifier: CAMN107ADE23
• Study Type: observational
• Target: 222
• Locations: 1 country
• Sites: 77

Brief Summary

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.

Conditions

Chronic Myeloid Leukemia

Keywords

Chronic myeloid leukemia; CML; NOFRETETE; Nilotinib

Outcome Measures

Primary Outcomes (8)

• Proportion of patients in Major molecular response (MMR), and Deep molecular response according to international standard (MR^4.0 and MR^4.5)

  Proportion of patients in MMR, MR\^4.0 and MR\^4.5 was collected

  24 months

• Time to achievement of an MR4.0 and MR4.5

  Time to achievement of an MR4.0 and MR4.5 was collected

  24 months

• Duration of an MR4.0 and MR4.5

  Duration of an MR4.0 and MR4.5 was collected

  24 months

• Proportion of patients whose molecular response is routinely analyzed by a MR4.5-certified laboratory

  Proportion of patients whose molecular response is routinely analyzed by a MR4.5-certified laboratory was collected

  24 months

• Proportion of European Treatment and Outcome Study for CML (EUTOS)-qualified laboratories that perform qRT-PCR.

  Proportion of European Treatment and Outcome Study for CML (EUTOS)-qualified laboratories that perform qRT-PCR was documented

  24 months

• Patient-reported QoL

  The EORTC QLQ-C30 questionnaire in conjunction with the EORTC QLQ-CML24 module was used to assess patient-reported QoL.

  24 months

• Patient adherence

  Patient adherence was documented using the MMAS-8 (Morisky et al., 2008) patient questionnaire.

  24 months

• Proportion of patients who discontinue Tyrosine kinase inhibitor (TKI) therapy

  Proportion of patients who discontinue Tyrosine kinase inhibitor (TKI) therapy was documented

  24 months

Study Arms (1)

Nilotinib

patients prescribed with nilotinib in routine medical practice

Other: Nilotinib

Interventions

Nilotinib OTHER

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

Also known as: Tasigna

Nilotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult male and female patients with diagnosed Philadelphia chromosome positive (Ph+) and/or Breakpoint cluster region-Abelson tyrosine kinase (Abelson murine leukemia proto-oncogene)+ Chronic myeloid leukemia who were being treated with nilotinib in first or any subsequent line and for whom treatment with nilotinib was indicated according to SmPC

You may qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (77)

Novartis Investigative Site

Freudenstadt, Baden-Wurttemberg, 72250, Germany

Location

Novartis Investigative Site

Aschaffenburg, Bavaria, 63739, Germany

Location

Novartis Investigative Site

Augsburg, Bavaria, 86152, Germany

Location

Novartis Investigative Site

Bayreuth, Bavaria, 95445, Germany

Location

Novartis Investigative Site

Coburg, Bavaria, 96450, Germany

Location

Novartis Investigative Site

Donauwörth, Bavaria, 86609, Germany

Location

Novartis Investigative Site

Kronach, Bavaria, 96317, Germany

Location

Novartis Investigative Site

Landshut, Bavaria, 84028, Germany

Location

Novartis Investigative Site

Munich, Bavaria, 80797, Germany

Location

Novartis Investigative Site

Frankfurt (Oder), Brandenburg, 15236, Germany

Location

Novartis Investigative Site

Baden-Württemberg, Heidenheim a.d.B, 89522, Germany

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Novartis Investigative Site

Erbach im Odenwald, Hesse, 64711, Germany

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Novartis Investigative Site

Goslar, Lower Saxony, 38642, Germany

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Novartis Investigative Site

Göttingen, Lower Saxony, 37073, Germany

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Novartis Investigative Site

Hanover, Lower Saxony, 30171, Germany

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Novartis Investigative Site

Twistringen, Lower Saxony, 27239, Germany

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Novartis Investigative Site

Westerstede, Lower Saxony, 26655, Germany

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Novartis Investigative Site

Aachen, North Rhine-Westphalia, 52064, Germany

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Novartis Investigative Site

Neuss, North Rhine-Westphalia, 41464, Germany

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Novartis Investigative Site

Ahaus, Northrhine Westfalia, 48683, Germany

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Novartis Investigative Site

Bad Salzuflen, Northrhine Westfalia, 32105, Germany

Location

Novartis Investigative Site

Hagen, Northrhine Westfalia, 58095, Germany

Location

Novartis Investigative Site

Iserlohn, Northrhine Westfalia, 58644, Germany

Location

Novartis Investigative Site

Neuwied, Rhineland-Palatinate, 56564, Germany

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Novartis Investigative Site

Bad Schlema, Saxony, 08301, Germany

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Novartis Investigative Site

Dresden, Saxony, 01127, Germany

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Novartis Investigative Site

Zittau, Saxony, 02763, Germany

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Novartis Investigative Site

Reinbek, Schleswig-Holstein, 21465, Germany

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Novartis Investigative Site

Altötting, 84503, Germany

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Novartis Investigative Site

Bad Liebenwerda, 04924, Germany

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Novartis Investigative Site

Bad Mergentheim, 97980, Germany

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Novartis Investigative Site

Bamberg, 96049, Germany

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Novartis Investigative Site

Berlin, 10709, Germany

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Novartis Investigative Site

Berlin, 12487, Germany

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Novartis Investigative Site

Berlin, 13055, Germany

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Novartis Investigative Site

Biberach, 88400, Germany

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Novartis Investigative Site

Bielefeld, 33604, Germany

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Novartis Investigative Site

Cologne, 50677, Germany

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Novartis Investigative Site

Erfurt, 99084, Germany

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Novartis Investigative Site

Erfurt, 99085, Germany

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Novartis Investigative Site

Frankfurt, 60398, Germany

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Novartis Investigative Site

Frankfurt, 60596, Germany

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Novartis Investigative Site

Gera, 07548, 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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Novartis Investigative Site

Hamburg, 20259, Germany

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Novartis Investigative Site

Hamelin, 31785, Germany

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Novartis Investigative Site

Hamm, 59063, Germany

Location

Novartis Investigative Site

Hanover, 30161, Germany

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Novartis Investigative Site

Heilbronn, 74072, Germany

Location

Novartis Investigative Site

Heilbronn, 74078, Germany

Location

Novartis Investigative Site

Hildesheim, 31135, Germany

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Novartis Investigative Site

Lemgo, 32657, Germany

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Novartis Investigative Site

Ludwigsburg, 71636, Germany

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Novartis Investigative Site

Memmingen, 87700, Germany

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Novartis Investigative Site

Merseburg, 06217, Germany

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Novartis Investigative Site

Moers, 47441, Germany

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Novartis Investigative Site

München, 80331, Germany

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Novartis Investigative Site

Neumünster, 24534, Germany

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Novartis Investigative Site

Nordhorn, 48527, Germany

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Novartis Investigative Site

Nuremberg, 90403, Germany

Location

Novartis Investigative Site

Nuremberg, 90449, Germany

Location

Novartis Investigative Site

Offenburg, 77652, Germany

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Novartis Investigative Site

Osnabrück, 49076, Germany

Location

Novartis Investigative Site

Porta Westfalica, 32457, Germany

Location

Novartis Investigative Site

Potsdam, 14467, Germany

Location

Novartis Investigative Site

Rotenburg (Wümme), 27356, Germany

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Novartis Investigative Site

Rüsselsheim am Main, 65428, Germany

Location

Novartis Investigative Site

Schorndorf, 73614, Germany

Location

Novartis Investigative Site

Singen, 78224, Germany

Location

Novartis Investigative Site

Speyer, 67346, Germany

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Novartis Investigative Site

Stolberg, 52222, Germany

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Novartis Investigative Site

Viersen, 45468, Germany

Location

Novartis Investigative Site

Wiesbaden, 65191, Germany

Location

Novartis Investigative Site

Wilhelmshaven, 26389, Germany

Location

Novartis Investigative Site

Wolfsburg, 38440, Germany

Location

Novartis Investigative Site

Würzburg, 97080, Germany

Location

Related Links

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

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

nilotinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 17, 2023
• Study Start: June 28, 2016
• Primary Completion: September 8, 2022
• Study Completion: September 8, 2022
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (77)