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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Myeloid Leukemia
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 222
- Locations
- 1
- Primary Endpoint
- Time to achievement of an MR4.0 and MR4.5
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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,
Outcomes
Primary Outcomes
Time to achievement of an MR4.0 and MR4.5
Time Frame: 24 months
Time to achievement of an MR4.0 and MR4.5 was collected
Proportion of patients whose molecular response is routinely analyzed by a MR4.5-certified laboratory
Time Frame: 24 months
Proportion of patients whose molecular response is routinely analyzed by a MR4.5-certified laboratory was collected
Patient-reported QoL
Time Frame: 24 months
The EORTC QLQ-C30 questionnaire in conjunction with the EORTC QLQ-CML24 module was used to assess patient-reported QoL.
Patient adherence
Time Frame: 24 months
Patient adherence was documented using the MMAS-8 (Morisky et al., 2008) patient questionnaire.
Proportion of patients in Major molecular response (MMR), and Deep molecular response according to international standard (MR^4.0 and MR^4.5)
Time Frame: 24 months
Proportion of patients in MMR, MR\^4.0 and MR\^4.5 was collected
Duration of an MR4.0 and MR4.5
Time Frame: 24 months
Duration of an MR4.0 and MR4.5 was collected
Proportion of European Treatment and Outcome Study for CML (EUTOS)-qualified laboratories that perform qRT-PCR.
Time Frame: 24 months
Proportion of European Treatment and Outcome Study for CML (EUTOS)-qualified laboratories that perform qRT-PCR was documented
Proportion of patients who discontinue Tyrosine kinase inhibitor (TKI) therapy
Time Frame: 24 months
Proportion of patients who discontinue Tyrosine kinase inhibitor (TKI) therapy was documented