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JOURNAL ONKOLOGIE – STUDIE
RETAIN

Retention Rate of Acalabrutinib in a Non-interventional Setting

Rekrutierend

NCT-Nummer:
NCT05645172

Studienbeginn:
Dezember 2022

Letztes Update:
29.04.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Leukemia, Lymphocytic, Chronic, B-Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
AstraZeneca

Collaborator:
-

Kontakt

AstraZeneca Clinical Study Information Center
Kontakt:
Phone: 1-877-240-9479
E-Mail: information.center@astrazeneca.com» Kontaktdaten anzeigen

Studienlocations
(3 von 51)

Research Site
86150 Augsburg
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
´04924 Bad Liebenwerda
(Brandenburg)
GermanyRekrutierend» Google-Maps
Research Site
13055 Berlin
(Berlin)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
85221 Dachau
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
44263 Dortmund
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Research Site
52353 Düren
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Research Site
99084 Erfurt
(Thüringen)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
60596 Frankfurt am Main
(Hessen)
GermanyRekrutierend» Google-Maps
Research Site
65929 Frankfurt am Main
(Hessen)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
30823 Garbsen
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Research Site
06110 Halle (Saale)
(Sachsen-Anhalt)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
30161 Hannover
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Research Site
30625 Hannover
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Research Site
30880 Laatzen
(Niedersachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
79539 Lörrach
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Research Site
31535 Neustadt am Rübenberge
(Niedersachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
90449 Nürnberg
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
26121 Oldenburg
(Niedersachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
33098 Paderborn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Research Site
32457 Porta Westfalica
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Research Site
42859 Remscheid
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Research Site
72764 Reutlingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Research Site
01589 Riesa
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
66113 Saarbrücken
(Saarland)
GermanyRekrutierend» Google-Maps
Research Site
04435 Schkeuditz
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
73614 Schorndorf
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
53721 Siegburg
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Research Site
71065 Sindelfinden
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Research Site
27239 Twistringen
(Niedersachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

This observational study will prospectively assess acalabrutinib therapy retention of CLL

patients one year and 2 years after treatment initiation with acalabrutinib in routine

clinical practice. Furthermore, therapy adherence, treatment efficacy, overall survival, and

QoL to analyse the possible influence of psychological aspects of the patient-based disease

perception, a four-group-segmentation for acceptance and perceived control of the health

state will be conducted. Finally, disease-, treatment-, and patient-specific factors possibly

affecting therapy retention will be analysed: sociodemographic factors, disease and treatment

characteristics, comorbidities, therapy adherence, treatment effectiveness, safety, QoL, and

psychological segmentation.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Age ≥ 18 years

- Diagnosis of CLL

- Ability to understand the study concept and to regularly complete patient

questionnaires from physical, mental, and linguistic perspectives

- Decision to start therapy with acalabrutinib according to the current SmPC. For

previously untreated patients as continuous therapy with or without obinutuzumab. OR

For patients with at least one prior CLL therapy as continuous monotherapy.

- Provision of signed informed consent form

Exclusion Criteria:

- Current or planned participation in an interventional clinical trial

- Contraindications to treatment with acalabrutinib according to the current SmPC

- Pregnancy or breast feeding

- Disease progression on prior BTKi therapy

- Start of acalabrutinib therapy more than 28 days prior to enrolment

Studien-Rationale

Primary outcome:

1. Retention rate of CLL (Time Frame - 1 year):
The primary outcome of this study is the retention rate of CLL patients receiving acalabrutinib in clinical practice after 1 year (= ratio of the number of patients still being prescribed acalabrutinib after 1 year to the number of patients at risk). Cases of death, ongoing treatment interruption, and lost to follow-up will be counted as patients not still being prescribed with acalabrutinib.



Secondary outcome:

1. Retention rate of CLL (Time Frame - 2 years):
The secondary outcome is the retention rate of CLL patients receiving acalabrutinib in clinical practice after 2 years.

2. General treatment adherence (Time Frame - assessed at baseline and 6, 12, and 24 months after start of acalabrutinib treatment):
General treatment adherence will be assessed over the whole observational period by the self-reported, 8-item structured MMAS-8 questionnaire.

3. reasons for and duration of therapy interruptions (Time Frame - time from first prescription until therapy interruptions; assessed up to 40 months):
Based on acalabrutinib treatment details, the reasons for and duration of therapy interruptions will be calculated and analysed.

4. TTD (Time Frame - time from start of acalabrutinib treatment until the date of final discontinuation or death; assessed up to 40 months.):
Based on acalabrutinib treatment details, the TTD, defined as the time from first prescription until the date of last intake or death, whichever occurs first, will be calculated and the reasons for therapy discontinuation will be analysed.

5. TTNT (Time Frame - time from start of acalabrutinib treatment until start of a subsequent CLL treatment; assessed up to 40 months.):
Based on acalabrutinib treatment details, the TTNT, defined as the time of first prescription until start date of the next CLL treatment will be calculated and the reasons for switch of treatment will be analysed. Cases of death will be censored and not considered as TTNT-relevant event.

6. TTNT-D (Time Frame - time from start of acalabrutinib treatment until start of a subsequent CLL treatment or death; assessed up to 40 months):
Based on acalabrutinib treatment details, the TTNT-D, defined as the time of first prescription until start date of the next CLL treatment or death, whichever occurs first, will be calculated.

7. Treatment efficacy and PFS (Time Frame - time from start of acalabrutinib treatment until disease progression or death by any cause, whichever occurs first; assessed up to 40 months.):
Treatment efficacy will be analysed by means of the overall treatment response (CR, PR, PRL, judged by the treating physician and recommended to be in accordance with the guidelines of the International Workshop on Chronic Lymphocytic Leukemia (iwCLL), modified for persistent lymphocytosis, the time to and duration of response, the percentage of patients without treatment response (SD, PD), as well as the time of PFS, defined as the time of first prescription until progression of the disease or death by any cause, whichever occurs first.

8. Overall survival (Time Frame - time from start of acalabrutinib treatment until death by any cause; assessed up to 40 months.):
Overall survival will be calculated as the time from first prescription until death by any cause.

9. Patient- and disease-specific factors possibly affecting the retention rate (Time Frame - up to 40 months):
Patient- and disease-specific factors possibly affecting the retention rate will be analysed for associations with the following variables: - Treatment effectiveness (treatment response, PFS)

10. Healths-related Quality of Life (HRQoL)-QLQ-C30 (Time Frame - Patient questionnaires will becollected at time points synchronised with regular visits during study, assessed up to 40 months):
The QoL, as measured by the self-reported QLQ-C30 questionnaires, will be assessed at baseline and every quarterly regular follow-up visit thereafter until end of observation. The time course of the QoL will be visualised and the mean difference from baseline until 6, 12, and 24 months after start of therapy will be calculated. Clinical significance will be defined as minimal important differences (MIDs) of at least 10 points (in either direction) for total scores or subscales of the QLQ-C30.

11. Healths-related Quality of Life (HRQoL)-EQ-5D-5L (Time Frame - Patient questionnaires will becollected at time points synchronised with regular visits during study, assessed up to 40 months):
The QoL, as measured by the self-reported EQ-5D-5L questionnaires, will be assessed at baseline and every quarterly regular follow-up visit thereafter until end of observation. The time course of the QoL will be visualised and the mean difference from baseline until 6, 12, and 24 months after start of therapy will be calculated.

12. Patient- and disease-specific factors possibly affecting the retention rate (Time Frame - up to 40 months):
Patient- and disease-specific factors possibly affecting the retention rate will be analysed for associations with the following variables: - Patient- and disease-specific characteristics (sociodemographic data, disease characteristics and severity, comorbidities (CIRS), comedication).

13. Patient- and disease-specific factors possibly affecting the retention rate (Time Frame - up to 40 months):
Patient- and disease-specific factors possibly affecting the retention rate will be analysed for associations with the following variables: - Treatment adherence (MMAS-8).

14. Patient- and disease-specific factors possibly affecting the retention rate (Psychological patient segmentation) (Time Frame - at Baseline):
Psychological patient segmentation as determinant for the disease acceptance and disease control will be performed during the baseline visit by using a questionnaire published by Bloem et al. in 2020

15. Patient- and disease-specific factors possibly affecting the retention rate (Time Frame - up to 40 months):
Patient- and disease-specific factors possibly affecting the retention rate will be analysed for associations with the following variables: - Safety (rate, severity, and duration of SAEs and ADRs)

Quelle: ClinicalTrials.gov


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