The Real World Study of Zanubrutinib 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

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: Zanubrutinib

• Study Type: Observational
• Enrollment (Estimated): 490

Contacts and Locations

• Study Contact: Name: Shenmiao Yang; Email: yangshenmiao@hotmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital

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 zanubrutinib over the period from July 1st, 2020 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 Zanubrutinib;
• 4.Prior or current use of Zanubrutinib for ≥3 months
• 5.At least one follow-up was recorded during Zanubrutinib treatment

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	PFS is defined as the duration from date of Zanubrutinib initiation to date of disease progression (PD [according to the physician's evaluation]) or death from any cause	up to two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	OS is defined as the time from the starting date of Zanubrutinib to the date of death due to any cause.	up to two years
Time to Next Therapy (TTNT)	The TTNT will be calculated as the difference between Zanubrutinib 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 two years

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 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; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Tyrosine Kinase Inhibitors; Zanubrutinib
• Other Study ID Numbers: 2024Zanu-RW-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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