ZPRÁVA O PRŮBĚHU KLINICKÉHO HODNOCENÍ HALF2019 (16.6.2022 – 15.6.2023)
| Title in English | REPORT ON THE PROGRESS OF THE HALF2019 CLINICAL EVALUATION (16/06/2022 – 15/06/2023) |
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| Authors | |
| Year of publication | 2023 |
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| Web | HALF2019 |
| Description | Submission of the annual report and DSUR for the period 16/06/2022 - 15/06/2023 of the clinical trial HALF2019: A prospective phase II clinical study evaluating the effectiveness and safety of discontinuation of tyrosine kinase inhibitors after a previous two-step dose reduction in patients with chronic myeloid leukemia in deep molecular remission. The medicinal product evaluated is imatinib, dasatinib, nilotinib (strength 200 mg and 150 mg). The sponsor of the study is Masaryk University. The Multicentric Ethics Committee initially approved the clinical evaluation at the Brno University Hospital on 16 October 2019. SÚKL granted permission on 5 November 2019. Clinical trial takes place in 8 centers in the Czech Republic. |