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

Study Overview
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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.

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.

Official Title
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Nilotinib for Patients With Chronic Myeloid Leukemia in First Line and Any Subsequent Line - a Non-interventional Study on the Assessment of Deep Molecular Response in CML Patients in Daily Routine.

Conditions
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Chronic Myeloid Leukemia

Intervention / Treatment
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* Other: Nilotinib


Participation Criteria
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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. Exclusion Criteria: There are no exclusion criteria, apart from the contraindications mentioned in the SmPC. Participating patients are not allowed to take part in a clinical trial in parallel,

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nilotinib<br>patients prescribed with nilotinib in routine medical practice | Other: Nilotinib<br>* There was no treatment allocation. Patients administered Nilotinib by prescription could be enrolled.<br>* Other names: Tasigna;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CML, Chronic myeloid leukemia, NOFRETETE, Nilotinib