the Real World Study of Orelabrutinib in the Treatment of CLL/SLL

Not yet recruiting

• Conditions: CLL/SLL

• Registration Number: NCT05975164
• Lead Sponsor: Shandong University

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.

Study Timeline

• Status Verified: 2023-07
• Study Start: 2023-07-25
• Study First Submitted: 2023-07-26
• Study First Submitted QC: 2023-07-26
• Last Update Submitted: 2023-07-26
• Study First Posted: 2023-08-03
• Last Update Posted: 2023-08-03
• Primary Completion: 2023-12-10
• Study Completion: 2024-07-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
safety	up to two years	Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Special Situations
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
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
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