Clinical registry of patients with chronic myeloid leukaemia (CML).
start of the project: April 2012
Tyrosine kinase inhibitors (TKI) introduction into chronic myeloid leukaemia (CML) therapy dramatically improved prognosis of patients with the disease, particularly of them with newly diagnosed CML in chronic phase (CP). Most of the data about efficacy and tolerance of TKI in this setting comes from clinical trials. Valid recommendations for CML management are derived mainly from trials data as well. The data relating to TKI use in daily clinical practice are still scarce. However, the extrapolation of the clinical trial results to an entire patient population is difficult and sometimes nearly impossible due to significant differences between the in-study and out-study patient populations, as was shown with CML and also with other malignant diseases. Furthermore, significant variability exists among study end point definitions, which makes comparison among clinical trial results relatively burdensome. Another aggravating issue is the potential for data unavailability when study subjects are taken off a particular study protocol.
In the Czech Republic, where CML patient care is specifically centralised among only seven specialised institutions, favourable conditions exist to obtain informative and comprehensive real-life data. Well-managed centralised care of CML patients permits comprehensive data about TKI efficacy and tolerance collection, treatment event monitoring and composite endpoints analyses, which can reveal particular therapy status in a more detailed and realistic manner.
The Infinity project belongs to a group of projects solved in cooperation between the Institute of Biostatistics and Analyses and the CELL group. IBA MU provides the technical solution of the registry and data analysis.
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