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.
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.
Study Type
OBSERVATIONAL
Enrollment
222
There was no treatment allocation. Patients administered Nilotinib by prescription could be enrolled.
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
Time frame: 24 months
Time to achievement of an MR4.0 and MR4.5
Time to achievement of an MR4.0 and MR4.5 was collected
Time frame: 24 months
Duration of an MR4.0 and MR4.5
Duration of an MR4.0 and MR4.5 was collected
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 24 months
Patient adherence
Patient adherence was documented using the MMAS-8 (Morisky et al., 2008) patient questionnaire.
Time frame: 24 months
Proportion of patients who discontinue Tyrosine kinase inhibitor (TKI) therapy
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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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Proportion of patients who discontinue Tyrosine kinase inhibitor (TKI) therapy was documented
Time frame: 24 months