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This is a Multicenter, Retrospective Real-world Study of Orelabrutinib in the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in China
Orelabrutinib is a novel BTK inhibitor with high selectivity and has been approved in China for relapsed/refractory CLL/SLL,, The purpose of this study is to describe the effectiveness and safety of orelabrutinib of chronic lymphocytic leukemia (CLL) in real world.
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | The ORR will be calculated as the proportion of participants who achieve either complete response (CR), partial response (PR) or partial response with lymphocytosis, as assessed by the participating physician. | up to two years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Next Therapy (TTNT) | The TTNT will be calculated as the difference betweenorelabrutinib initiation date and initiation date of the first next therapy for CLL | up to two years |
| Progression Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
1.Patients who received orelabrutinib in a prospective clinical trial
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Patients who received orelabrutinib in real world
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Li | Contact | 18560089739 | liwei_medicine@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chunyan Ji, Dr. | Qilu Hospital of Shandong University | Principal Investigator |
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PFS is defined as the duration from date of orelabrutinib initiation to date of disease progression (PD [according to the physician's evaluation]) or death from any cause
| up to two years |
| response rate of Hematologic Parameters | the proportion of participants who had abnormal baseline hemoglobin, or platelet, or lymphocyte counts returned to normal levels or had ≥50% increases in hemoglobin and platelets or ≥50% decreases in lymphocyte counts | up to two years |
| safety | Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Special Situations | up to two years |