A Retrospective Real-world Study of Orelabrutinib in the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Shandong University0 sites50 target enrollmentJuly 25, 2023

ConditionsCLL/SLL

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: CLL/SLL
Sponsor: Shandong University
Enrollment: 50
Primary Endpoint: Overall Response Rate (ORR)
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 25, 2023

End Date

July 10, 2024

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Shandong University

Responsible Party

Principal Investigator

Chunyan Ji

Prof.

Shandong University

Eligibility Criteria

Inclusion Criteria

•Age ≥18 years old
•Patients with a definite diagnosis of CLL/SLL
•Prior or current use of orelabrutinib for ≥3 months
•At least one follow-up was recorded during orelabrutinib treatment

Exclusion Criteria

•1.Patients who received orelabrutinib in a prospective clinical trial

Outcomes

Primary Outcomes

Overall Response Rate (ORR)

Time Frame: 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.