Publication details
DEVELOPMENT SAFETY UPDATE REPORT HALF2019 Období: 16.6.2023 – 15.6.2024
| Title in English | HALF2019 DEVELOPMENT SAFETY UPDATE REPORT Period: 16.6.2023 – 15.6.2024 |
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| Authors | |
| Year of publication | 2024 |
| MU Faculty or unit | |
| web | HALF |
| Description | The fourth periodic report on the HALF study evaluates the safety data received by the study sponsor during the period from 16.6.2023 to 15.6.2024. The clinical trial is taking place in the Czech Republic in eight centers. Chronic myeloid leukemia (CML) is a clonal myeloproliferative disease with an incidence of 1.2 cases per 100,000 population, representing about 15% of newly diagnosed leukemias in adults. It is characterized by the presence of the so-called Philadelphia chromosome (Ph1) resulting from a translocation between chromosomes 9 and 22, and the fusion gene BCR-ABL1. The constitutively activated tyrosine kinase Bcr-Abl, which is encoded by the BCR-ABL1 gene, is responsible for the uncontrolled proliferation of hematopoietic cells. The presence of a genetic abnormality with strong pathogenetic potential has enabled the development of specific inhibitors of the pathological tyrosine kinase (tyrosine kinase inhibitors, TKI). The expected survival time of patients with CML diagnosed in the chronic phase (CP) is approaching that of the general population thanks to therapy. |