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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: CLL
• Intervention / Treatment: Drug: BTK inhibitor

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Shengmiao Yang, MD; Email: yangshenmiao@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Investigators participating in this observational study should include all patients with CLL who initiated treatment with BTK inhibitor over the period from Dec. 1st, 2017 to the present, regardless of the treatment status at the time of inclusion. Thus, at the time of enrolment and retrospective data collection, patients may still be on treatment or have stopped treatment for any reason.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: August 13, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Disease Attributes; Hematologic Diseases; Leukemia; Leukemia, B-Cell; Chronic Disease; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid
• Other Study ID Numbers: BTKi-CLL-RWE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No