Current Status of BTKi Treatment for CLL/SLL in China

Current Status and Influencing Factors of Chinese Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Undergoing Treatment With Bruton's Tyrosine Kinase Inhibitors

BTKi has become the standard treatment regimen for CLL/SLL，there is a lack of large-scale real-world studies on the use status and related influencing factors of BTK inhibitors. Therefore, we plan to conduct this multicenter retrospective cross-sectional study to understand the current situation of BTK inhibitor treatment for CLL/SLL patients in China and the related influencing factors, and to explore more suitable treatment patterns based on this.

Study Overview

• Status: Recruiting
• Conditions: CLL/SLL
• Intervention / Treatment: Drug: BTK inhibitor

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

Contacts and Locations

• Study Contact: Name: Huayuan Zhu, MD; Phone Number: 025-58530260; Email: huayuan.zhu@hotmail.com

Study Locations

• China
  • Jiangsu
    • Nanjin, Jiangsu, China, 210029
      • Recruiting
      • Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
      • Contact: Huayuan Zhu, PhD，MD; Phone Number: 86 25 68306034; Email: huayuan.zhu@hotmail.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

CLL/SLL Patient who receiving BTKi treatment

Description

Inclusion Criteria:

• Age ≥ 18 years;
• Patients with a confirmed diagnosis of CLL/SLL;
• Received BTK inhibitor treatment between February 2023 and February 2024.

Exclusion Criteria:

• Patients with other types of lymphoma;
• Cases deemed unsuitable for inclusion in this study by the investigators.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BTK inhibitor treated; investigate the current situation of BTK inhibitor treatment for CLL/SLL patients in China and the related influencing factors, including the efficacy and safety, the drug swith between different BTKis，the BTKi based timed limited therapy, etc	Drug: BTK inhibitor; BTKi can refer to Orelabrutinib, Ibrutinib, Zanubrutinib, and Acalabrutinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient characteristics of those receiving BTKi treatment	Describe the patient characteristics of those receiving BTKi treatment, including age, gender, etc	up to one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall response rate	Assessed according to the iwCLL2018 criteria	up to one year
Incidence of adverse reactions	Assessed according to the CTCAE 5.0 criteria	up to one year

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2024
• Primary Completion (Estimated): February 12, 2025
• Study Completion (Estimated): July 12, 2025

Study Registration Dates

• First Submitted: July 14, 2024
• First Submitted That Met QC Criteria: July 14, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 14, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PICASSO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No