The Real World Study of BTK Inhibitor in the Treatment of Chronic Lymphocytic Leukemia in China

Not yet recruiting

• Conditions: CLL

• Registration Number: NCT06557304
• Lead Sponsor: Peking University People's Hospital

Brief Summary

This is a Multicenter, Retrospective Real-world Study of Zanubrutinib in the Treatment of Chronic Lymphocytic Leukemia in China

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-13
• Study First Posted: 2024-08-16
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Study Start: 2024-09-01
• Primary Completion: 2026-09-01
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Patients aged ≥18 years old
2. Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) requiring treatment (iwCLL [International Workshop on Chronic Lymphocytic Leukemia] criteria)；
3. Treatment-naïve OR Refractory Recurrence CLL patients who were initiated on BTK inhibitor;
4. Prior or current use of BTK inhibitor for ≥3 months
5. At least one follow-up was recorded during BTK inhibitor treatment

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival	up to five years	OS is defined as the time from the starting date of BTK inhibitor to the date of death due to any cause.

Secondary Outcome Measures

Name	Time	Method
Time to Next Therapy (TTNT)	up to two years	The TTNT will be calculated as the difference between BTK inhibitor initiation date and initiation date of the first next therapy for CLL
Adverse Events	up to five years	Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Special Situations