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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05645172




Registration number
NCT05645172
Ethics application status
Date submitted
10/11/2022
Date registered
9/12/2022

Titles & IDs
Public title
Retention Rate of Acalabrutinib in a Non-interventional Setting
Scientific title
Retention Rate of Acalabrutinib in a Non-interventional Setting
Secondary ID [1] 0 0
D8224R00001
Universal Trial Number (UTN)
Trial acronym
RETAIN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukaemia (CLL) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cohort 1 - adult CLL patients (= 18 years of age) newly prescribed with acalabrutinib according to clinical routine will be included independent of the patient age, disease stage, existence of genetic risk factors, comorbidities, therapy line, and of the application as combination therapy with obinutuzumab or as monotherapy.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Retention rate of CLL
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Retention rate of CLL
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
General treatment adherence
Timepoint [2] 0 0
assessed at baseline and 6, 12, and 24 months after start of acalabrutinib treatment
Secondary outcome [3] 0 0
reasons for and duration of therapy interruptions
Timepoint [3] 0 0
time from first prescription until therapy interruptions; assessed up to 40 months
Secondary outcome [4] 0 0
TTD
Timepoint [4] 0 0
time from start of acalabrutinib treatment until the date of final discontinuation or death; assessed up to 40 months.
Secondary outcome [5] 0 0
TTNT
Timepoint [5] 0 0
time from start of acalabrutinib treatment until start of a subsequent CLL treatment; assessed up to 40 months.
Secondary outcome [6] 0 0
TTNT-D
Timepoint [6] 0 0
time from start of acalabrutinib treatment until start of a subsequent CLL treatment or death; assessed up to 40 months
Secondary outcome [7] 0 0
Treatment efficacy and PFS
Timepoint [7] 0 0
time from start of acalabrutinib treatment until disease progression or death by any cause, whichever occurs first; assessed up to 40 months.
Secondary outcome [8] 0 0
Overall survival
Timepoint [8] 0 0
time from start of acalabrutinib treatment until death by any cause; assessed up to 40 months.
Secondary outcome [9] 0 0
Patient- and disease-specific factors possibly affecting the retention rate
Timepoint [9] 0 0
up to 40 months
Secondary outcome [10] 0 0
Healths-related Quality of Life (HRQoL)-QLQ-C30
Timepoint [10] 0 0
Patient questionnaires will becollected at time points synchronised with regular visits during study, assessed up to 40 months
Secondary outcome [11] 0 0
Healths-related Quality of Life (HRQoL)-EQ-5D-5L
Timepoint [11] 0 0
Patient questionnaires will becollected at time points synchronised with regular visits during study, assessed up to 40 months
Secondary outcome [12] 0 0
Patient- and disease-specific factors possibly affecting the retention rate
Timepoint [12] 0 0
up to 40 months
Secondary outcome [13] 0 0
Patient- and disease-specific factors possibly affecting the retention rate
Timepoint [13] 0 0
up to 40 months
Secondary outcome [14] 0 0
Patient- and disease-specific factors possibly affecting the retention rate (Psychological patient segmentation)
Timepoint [14] 0 0
at Baseline
Secondary outcome [15] 0 0
Patient- and disease-specific factors possibly affecting the retention rate
Timepoint [15] 0 0
up to 40 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/10/2026
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Amberg
Country [2] 0 0
Germany
State/province [2] 0 0
Aschaffenburg
Country [3] 0 0
Germany
State/province [3] 0 0
Augsburg
Country [4] 0 0
Germany
State/province [4] 0 0
Bad Homburg
Country [5] 0 0
Germany
State/province [5] 0 0
Bad Liebenwerda
Country [6] 0 0
Germany
State/province [6] 0 0
Bautzen
Country [7] 0 0
Germany
State/province [7] 0 0
Berlin
Country [8] 0 0
Germany
State/province [8] 0 0
D Ren
Country [9] 0 0
Germany
State/province [9] 0 0
Dachau
Country [10] 0 0
Germany
State/province [10] 0 0
Delitzsch
Country [11] 0 0
Germany
State/province [11] 0 0
Dessau
Country [12] 0 0
Germany
State/province [12] 0 0
Dortmund
Country [13] 0 0
Germany
State/province [13] 0 0
Erfurt
Country [14] 0 0
Germany
State/province [14] 0 0
Frankfurt am Main
Country [15] 0 0
Germany
State/province [15] 0 0
Garbsen
Country [16] 0 0
Germany
State/province [16] 0 0
Halle (Saale)
Country [17] 0 0
Germany
State/province [17] 0 0
Halle
Country [18] 0 0
Germany
State/province [18] 0 0
Hannover
Country [19] 0 0
Germany
State/province [19] 0 0
Herrsching
Country [20] 0 0
Germany
State/province [20] 0 0
Kulmbach
Country [21] 0 0
Germany
State/province [21] 0 0
L Rrach
Country [22] 0 0
Germany
State/province [22] 0 0
Laatzen
Country [23] 0 0
Germany
State/province [23] 0 0
Landshut
Country [24] 0 0
Germany
State/province [24] 0 0
Lebach
Country [25] 0 0
Germany
State/province [25] 0 0
Leipzig
Country [26] 0 0
Germany
State/province [26] 0 0
M Nchen
Country [27] 0 0
Germany
State/province [27] 0 0
N Rnberg
Country [28] 0 0
Germany
State/province [28] 0 0
Naunhof
Country [29] 0 0
Germany
State/province [29] 0 0
Neustadt Am R Benberge
Country [30] 0 0
Germany
State/province [30] 0 0
Oldenburg
Country [31] 0 0
Germany
State/province [31] 0 0
Paderborn
Country [32] 0 0
Germany
State/province [32] 0 0
Pasing
Country [33] 0 0
Germany
State/province [33] 0 0
Pirna
Country [34] 0 0
Germany
State/province [34] 0 0
Porta Westfalica
Country [35] 0 0
Germany
State/province [35] 0 0
Potsdam
Country [36] 0 0
Germany
State/province [36] 0 0
Remscheid
Country [37] 0 0
Germany
State/province [37] 0 0
Reutlingen
Country [38] 0 0
Germany
State/province [38] 0 0
Riesa
Country [39] 0 0
Germany
State/province [39] 0 0
Saalfeld
Country [40] 0 0
Germany
State/province [40] 0 0
Saarbr Cken
Country [41] 0 0
Germany
State/province [41] 0 0
Schkeuditz
Country [42] 0 0
Germany
State/province [42] 0 0
Schorndorf
Country [43] 0 0
Germany
State/province [43] 0 0
Siegburg
Country [44] 0 0
Germany
State/province [44] 0 0
Sindelfinden
Country [45] 0 0
Germany
State/province [45] 0 0
Straubing
Country [46] 0 0
Germany
State/province [46] 0 0
Twistringen
Country [47] 0 0
Germany
State/province [47] 0 0
Weiden
Country [48] 0 0
Germany
State/province [48] 0 0
Zittau

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05645172