Zpráva o průběhu klinického hodnocení TIGER za období: 3. červenec 2021 - 2. červenec 2022
| Title in English | Clinical trial progress report TIGER for the period: July 3, 2021 - July 2, 2022 |
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| Authors | |
| Year of publication | 2022 |
| MU Faculty or unit | |
| Web | TIGER |
| Description | EudraCT number: 2010-024262-22 The clinical trial (CT) TIGER - Treatment optimization of newly diagnosed Ph/BCR-ABL positive patients with chronic myeloid leukemia (CML) in chronic phase with nilotinib vs. nilotinib plus interferon-alpha induction and nilotinib or interferon-alpha maintenance therapy. Primary objectives are to evaluate the rate of MMR at 18 months of nilotinib vs. nilotinib + pegylated interferon alpha (Peg-IFN?2b) in adult patients with newly diagnosed Ph/BCR-ABL positive CML in the chronic phase. Annual report on the progress of clinical trial describes the course of clinical trial in the observed period. The report includes the sponsor's notification on the official closure of the treatment phase of the clinical trial and subsequent treatment measures, on the database closure and completion of the study documentation of all enrolled patients in the Czech Republic, incidence of serious adverse events, identified protocol violations, information on newly identified characteristics on IMP in relation to safety and efficacy, newly adopted measures (eg interventions of ethics committees, foreign control authorities, possible restrictive interventions of the contracting authority) and information on performed internal audits or audits by the contracting authority if applicable. |
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