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.
Study Type
OBSERVATIONAL
Enrollment
50
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.
Time frame: up to two years
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
Time frame: up to two years
Progression Free Survival (PFS)
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
Time frame: 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
Time frame: up to two years
safety
Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Special Situations
Time frame: up to two years
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