Klaus Fenchel, Prof. Dr. Study Chair Onkologische Praxisklinik Hämatologie/ Onkologie und Gerinnungsstörungen
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Daniel Kummer, Dr. Kontakt: Phone: +49761152420 E-Mail: Cicero@iomedico.com» Kontaktdaten anzeigen
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Prof. Dr. Fenchel & Dr. Winkler MVZ Träger GbR 07318 Saalfeld (Thüringen) GermanyRekrutierend» Google-Maps Ansprechpartner: Klaus Fenchel, Prof. Dr.» Ansprechpartner anzeigen
1. Incidence proportion of patients with major bleeding event according to Schulman et al. (Time Frame - Baseline until end of acalabrutinib treatment (+ 30 days safety follow-up); up to 36 months): Bleeding event is defined as major according to Schulmann et al., if it is fatal (contributes to death) and/or symptomatic in a critical area or organ (such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome) and/or causing a decrease in hemoglobin of 2 g/dL (1.24 mmol/l) or more or requires a transfusion of 2 or more units of whole blood or red blood cells.
Incidence proportion (cumulative incidence) is calculated as the number of patients with bleeding event while on treatment (+30 days safety follow-up), divided by the number of patients in the full analysis population.
Secondary outcome:
1. Incidence proportion of clinically relevant non-major (CRNM) bleeding events (Time Frame - Baseline, up to 36 months): CRNM bleeding is defined as bleeding that does not meet the criteria for major bleeding according to Schulman et al. but is associated with the need for medical intervention and/or personal contact with a physician and/or hospitalization or increase in level of care.
2. Major (according to Schulman et al.) and/or CRNM bleeding events. (Time Frame - Baseline, up to 36 months): Incidence proportion of major (according to Schulman et al.) and/or CRNM bleeding events.
3. Any bleeding event. (Time Frame - Baseline, up to 36 months): Incidence proportion of any bleeding event.
4. Incidence proportion of major bleeding according to Ghia et al. (Time Frame - Baseline, up to 36 months): Major bleeding according to Ghia et al. is defined as any serious OR grade ≥3 hemorrhage OR central nervous system (CNS) hemorrhage of any grade, excluding immune thrombocytopenic purpura.
5. Time to first Occurrence of major bleeding events (Time Frame - Baseline, up to 36 months): Time to first occurrence of major (according to Schulman et al.) bleeding events.
6. Incidence proportion of central nervous system (CNS) bleeding events (Time Frame - Baseline, up to 36 months): Frequencies of patients with CNS bleeding events.
7. Patient safety regarding mortality (Time Frame - Baseline, up to 36 months): Mortality from all causes during acalabrutinib therapy.
8. Patient safety in terms of interactions with effectiveness of DOAC (Time Frame - Baseline, up to 36 months): Rate of any new or recurrent ischemic stroke or arterial systemic embolism or venous thromboembolic events.
9. VTE (venous thromboembolism)-related death (Time Frame - Baseline, up to 36 months): Incidence proportion of VTE-related death.
10. Overall response rate (ORR) (Time Frame - Baseline, up to 36 months): ORR is defined as proportion of patients with any response (partial or complete remission) overall.
11. Progression-free survival (PFS) (Time Frame - Baseline, up to 36 months): Time from start of acalabrutinib to occurrence of progressive disease or death from any cause, whichever comes first.
12. Overall survival (OS) (Time Frame - Baseline, up to 36 months): OS is defined as time from first administration of acalabrutinib to death from any cause.
13. Therapy decision making (Time Frame - Baseline): Frequencies of parameters affecting therapy choice.
14. Previous therapies (Time Frame - Baseline): Frequencies and percentages of previous therapies
15. Acalabrutinib (+/- obinutuzumab) treatment: Duration (Time Frame - Baseline, up to 36 months): Analysis of treatment duration of acalabrutinib using descriptive statistics.
16. Acalabrutinib (+/- obinutuzumab) treatment: Dose intensity (Time Frame - Baseline, up to 36 months): Analysis of dose intensity of acalabrutinib treatment with reference to the SmPC (absolute and relative) using descriptive statistics.
17. Obinutuzumab treatment: Duration (Time Frame - Baseline, up to 36 months): Analysis of treatment duration of obinutuzumab using descriptive statistics
18. Reasons for end of treatment of obinutuzumab (Time Frame - Baseline, up to 36 months): Frequencies and percentages of reasons for end of obinutuzumab treatment.
19. Types of DOAC (Time Frame - Baseline, up to 36 months): Type of DOAC used (edoxaban, rivaroxaban, dabigatran and apixaban).
20. Reasons for DOAC treatment (Time Frame - Baseline, up to 36 months): Frequencies and precentages of reasons for DOAC treatment.
21. DOAC treatment: Duration (Time Frame - Baseline, up to 36 months): Analysis of DOAC treatment duration using descriptive statistics.
22. DOAC treatment: Dose modifications (Time Frame - Baseline, up to 36 months): Frequencies and percentages of dose modifications of DOAC treatment.
23. DOAC treatment: Reasons for dose modifications (Time Frame - Baseline, up to 36 months): Frequencies and percentages of reasons for dose modifications of DOAC treatment.
24. DOAC treatment: Reasons for end of treatment (Time Frame - Baseline, up to 36 months): Frequencies and percentages of reasons for end of DOAC treatment.
25. Time from onset to DOAC to start of acalabrutinib (Time Frame - Baseline, up to 36 months): Assessment of time from onset of DOAC to start of acalabrutinib therapy using descriptive statistics.
26. Concomitant medication (Time Frame - Baseline, up to 36 months): Frequency of concomitant medication other than DOAC.
