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

CLL/SLL Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05975164
• Other study ID #: Orelabrutinib in real world
• Status: Not yet recruiting
• Start date: July 25, 2023
• Est. completion date: July 10, 2024

Study information

• Verified date: July 2023
• Source: Shandong University
• Contact: Wei Li
• Phone: 18560089739
• Email: liwei_medicine[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a Multicenter, Retrospective Real-world Study of Orelabrutinib in the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in China

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 10, 2024
• Est. primary completion date: December 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CLL/SLL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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	up to two years
Secondary	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
Secondary	safety	Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Special Situations	up to two years