Trial Title:
Retention Rate of Acalabrutinib in a Non-interventional Setting
NCT ID:
NCT05645172
Condition:
Chronic Lymphocytic Leukaemia (CLL)
Conditions: Official terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Conditions: Keywords:
Acalabrutinib
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
Retention rate of acalabrutinib in a non-interventional setting. This is a prospective,
multicentre, non-interventional study to collect real-world data on retention rates of
CLL patients prescribed with acalabrutinib in Germany.
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.
Criteria for eligibility:
Study pop:
CLL patients with a newly initiated acalabrutinib treatment in routine clinical practice
are planned to be included from approximately 75 sites in Germany over a recruitment
period of 16 months.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Amberg
Zip:
92224
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Aschaffenburg
Zip:
63739
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Augsburg
Zip:
86150
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bad Homburg
Zip:
61352
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bad Liebenwerda
Zip:
4924
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bautzen
Zip:
2625
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Berlin
Zip:
10117
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Berlin
Zip:
13055
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Berlin
Zip:
13156
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
D Ren
Zip:
52353
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Dachau
Zip:
85221
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Delitzsch
Zip:
04509
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Dessau
Zip:
06487
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Dortmund
Zip:
44263
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Erfurt
Zip:
99084
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Erfurt
Zip:
99085
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Frankfurt am Main
Zip:
60596
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Frankfurt am Main
Zip:
65929
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Garbsen
Zip:
30823
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Halle (Saale)
Zip:
06110
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Halle
Zip:
06110
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hannover
Zip:
30161
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hannover
Zip:
30625
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Herrsching
Zip:
82211
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kulmbach
Zip:
95326
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
L Rrach
Zip:
79539
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Laatzen
Zip:
30880
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Landshut
Zip:
72764
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Lebach
Zip:
66822
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Leipzig
Zip:
4103
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Leipzig
Zip:
4289
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
M Nchen
Zip:
80804
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
M Nchen
Zip:
81377
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
N Rnberg
Zip:
90449
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Naunhof
Zip:
4683
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Neustadt Am R Benberge
Zip:
31535
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Oldenburg
Zip:
26121
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Paderborn
Zip:
33098
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Pasing
Zip:
81281
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Pirna
Zip:
01796
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Porta Westfalica
Zip:
32457
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Potsdam
Zip:
14482
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Remscheid
Zip:
42859
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Reutlingen
Zip:
72764
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Riesa
Zip:
01589
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Saalfeld
Zip:
07318
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Saarbr Cken
Zip:
66113
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Schkeuditz
Zip:
04435
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Schorndorf
Zip:
73614
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Siegburg
Zip:
53721
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sindelfinden
Zip:
71065
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Straubing
Zip:
94315
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Twistringen
Zip:
27239
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Weiden
Zip:
92637
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Zittau
Zip:
2763
Country:
Germany
Status:
Recruiting
Start date:
December 12, 2022
Completion date:
October 15, 2026
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05645172
