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This is a multi-site observational study of medical events of interest (MEOI) and health-related quality of life (HRQoL) in chronic lymphocytic leukemia (CLL) patients initiating treatment with the Bruton's tyrosine kinase inhibitors (BTKi) acalabrutinib or ibrutinib in the United States (US)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acalabrutinib | CLL patients initiating acalabrutinib alone or in combination with an anti-CD20 mAb | ||
| Ibrutinib | CLL patients receiving ibrutinib alone or in combination with an anti-CD20 mAb |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Characteristics | To describe the demographic and clinical characteristics of CLL patients who have recently initiated acalabrutinib or ibrutinib. | Baseline |
| Chart Recorded Medical Events of Interest | To describe MEOI experienced by CLL patients who have recently initiated acalabrutinib or ibrutinib using medical chart abstracted data, over a 24-month period | 24 Month Follow-up |
| Patient Reported Medical Events of Interest | To describe MEOI experienced by CLL patients who have recently initiated acalabrutinib or ibrutinib using patient reported data, over a 24-month period. | 24 month follow-up |
| HRQoL | To describe HRQoL for CLL patients who recently initiated acalabrutinib or ibrutinib using patient reported data, over a 24-month period | 24 month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients who have recently initiated treatment for CLL/SLL with acalabrutinib or ibrutinib in the front-line or relapsed/refractory setting
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Fountain Valley | California | 92708 | United States | ||
| 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
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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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| Redlands |
| California |
| 92373 |
| United States |
| Research Site | Boca Raton | Florida | 33486 | United States |
| Research Site | Fort Lauderdale | Florida | 33308 | United States |
| Research Site | St. Petersburg | Florida | 33709 | United States |
| Research Site | Tallahassee | Florida | 32308 | United States |
| Research Site | Tamarac | Florida | 33321 | United States |
| Research Site | Tampa | Florida | 33705-1407 | United States |
| Research Site | Savannah | Georgia | 31405 | United States |
| Research Site | Honolulu | Hawaii | 96813-5516 | United States |
| Research Site | Jackson | Mississippi | 39202 | United States |
| Research Site | Berkeley Heights | New Jersey | 07922 | United States |
| Research Site | Amherst | New York | 14228 | United States |
| Research Site | Charlotte | North Carolina | 27103 | United States |
| Research Site | Philadelphia | Pennsylvania | 19111 | United States |
| Research Site | York | Pennsylvania | 17403 | United States |
| 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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