CLL/SLL
Conditions
Brief summary
This is a Multicenter, Retrospective Real-world Study of Orelabrutinib in the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in China
Detailed description
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.
Interventions
None listed
Sponsors
Shandong University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years old 2. Patients with a definite diagnosis of CLL/SLL 3. Prior or current use of orelabrutinib for ≥3 months 4. At least one follow-up was recorded during orelabrutinib treatment
Exclusion criteria
1.Patients who received orelabrutinib in a prospective clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | up to two years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Next Therapy (TTNT) | up to two years | The TTNT will be calculated as the difference betweenorelabrutinib initiation date and initiation date of the first next therapy for CLL |
| Progression Free Survival (PFS) | up to two years | 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 |
| response rate of Hematologic Parameters | up to two years | 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 |
| safety | up to two years | Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Special Situations |
Contacts
Primary ContactWei Li
Outcome results
None listed