The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Retention Rate of Acalabrutinib in a Non-interventional Setting (RETAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05645172
Recruitment Status : Recruiting
First Posted : December 9, 2022
Last Update Posted : April 29, 2024
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease
Chronic Lymphocytic Leukaemia (CLL)

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.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Retention Rate of Acalabrutinib in a Non-interventional Setting
Actual Study Start Date : December 12, 2022
Estimated Primary Completion Date : April 15, 2026
Estimated Study Completion Date : April 15, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Measures :
  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)



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05645172


Contacts
Layout table for location contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
Show Show 51 study locations
Sponsors and Collaborators
AstraZeneca
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT05645172    
Other Study ID Numbers: D8224R00001
First Posted: December 9, 2022    Key Record Dates
Last Update Posted: April 29, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Time Frame: 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.
Access Criteria: 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
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Keywords provided by AstraZeneca:
Acalabrutinib
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Chronic Disease
Disease Attributes
Pathologic Processes