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Acalabrutinib received European Medicines Agency approval on November 2020 for for CLL adult patients, either as monotherapy or in combination with obinutuzumab, in previously untreated patients or as monotherapy in patients who have received at least one prior therapy and is reimbursed in Romania since January 2023. In the absence of disease registries or national datasets patient population receiving acalabrutinib in real life setting is not well characterized. The study aims to look into this population outcomes and clinical characteristics having as primary objective time to discontinuation by line of treatment and secondary objectives: reasons for discontinuation, effectiveness of acalabrutinib in real-life practice, baseline clinical and demographic characteristics, treatment patterns and major determinants of treatment discontinuation. The study will retrospectively collect longitudinal data from 250 patients at national level,at pre-defined timepoints for 3 years, from 2 sequential cohorts,1st one enrolled on December 2023 and 2nd one enrolled in December 2024 based on the acalabrutinib start year..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | December 2023 - collecting data retrospectively from patients routinely initiated on acalabrutinib between January - December 2023 |
| |
| Cohort 2 | December 2024-collecting data retrospectively from patients routinely initated on acalabrutinib between January - December 2024 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non interventional study | Drug | CLL patients routinely initiated on acalabrutinib by their physician between January 2023 -December 2024. Retrospective secondary data collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to acalabrutinib treatment discontinuation (TTD) | TTD is defined as the time between the first day of acalabrutinib treatment and the day that acalabrutinib is definitely stopped for whatever reason or death | Once a year during the 3 years of follow up since acalabrutinib start |
| Measure | Description | Time Frame |
|---|---|---|
| Reasons for treatment discontinuation | Reasons for acalabrutinib interruption | Once a year until end of the study ( 3 years from start of acalabrutinib) |
| effectiveness of acalabrutinib | Real world progression free survival (rwPFS) is defined as the time from initiation of acalabrutinib therapy (index date) until earliest record of disease progression determined by physicians' assessment (clinical or radiological progression or start of a new line therapy),or death |
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Inclusion Criteria:
Exclusion Criteria:
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CLL patients routinely initiated on acalabrutinib in front-line or subsequent treatment during the study eligibility window January 2023-December 2024
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Piteşti | Argeş | 110084 | Romania | ||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests 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 approved.
Supporting
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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| Once a year until end of the study ( 3 years from start of acalabrutinib) |
| Baseline clinical and demographic characteristics | Demographic characteristics (age,gender, BMI) and disease characteristics (age at diagnosis, staging, symptoms, active disease criteria,previous treatment | At first data collection for cohort 1 in December 2023 and at first data collection for cohort 2 in December 2024 |
| acalabrutinib interruption | Percentage of patients with acalabrutinib interruption | Once a year until end of the study (3 years from the start of acalabrutinib) |
| time to interruption | Time between first day of acalabrutinib and the day of first interruption of acalabrutinib | Once a year until end of the study ( 3 years from start of acalabrutinib) |
| duration of interruption | Time between the first day of acalabrutinib interruption and the first day of acalabrutinib restart | once a year until the end of the study ( 3 years from acalabrutinib start) |
| acalabrutinib dose changes | Percentage of patients with dose changes | once a year until the end of the study ( 3 years from acalabrutinib start) |
| Reasons of acalabrutinib dose changes | Reasons of acalabrutinib dose changes (all including adverse events) | once a year until the end of the study ( 3 years from acalabrutinib start) |
| Major determinant of treatment discontinuation | a multivariate analysis (Cox model) will be performed to study correlation between TTD and patient characteristics at baseline. | once a year until end of the study( 3 years from acalabrutinib start) |
| Oradea |
| Bihor County |
| 410469 |
| Romania |
| Research Site | Cluj-Napoca | Cluj | 400015 | Romania |
| Research Site | Craiova | Dolj | 200143 | Romania |
| Research Site | Deva | Hunedoara County | 330084 | Romania |
| Research Site | Baia Mare | Maramureş | 430031 | Romania |
| Research Site | Târgu Mureş | Mureș County | 540136 | Romania |
| Research Site | Piatra Neamţ | Neamț County | 610136 | Romania |
| Research Site | Timișoara | Timiș County | 300239 | Romania |
| Research Site | Timișoara | Timiș County | 300254 | Romania |
| Research Site | Focşani | Vrancea | 620034 | Romania |
| Research Site | Brasov | 500052 | Romania |
| Research Site | Bucharest | 20125 | Romania |
| Research Site | Bucharest | 22328 | Romania |
| Research Site | Bucharest | 301710 | Romania |
| Research Site | Bucharest | 30171 | Romania |
| Research Site | Bucharest | 50098 | Romania |
| Research Site | Galati | 800578 | Romania |
| Research Site | Iași | 700483 | Romania |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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