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NCT Number: NCT06508684

Current Status of BTKi Treatment for CLL/SLL in China

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.

Recruiting

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Key information

Conditions

CLL/SLL

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital

Nanjin, Jiangsu, 210029, China

Location status: Recruiting

Location contact

Huayuan Zhu, PhD，MD

CONTACT

[email protected]

86 25 68306034

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BTK inhibitor

Drug

BTKi can refer to Orelabrutinib, Ibrutinib, Zanubrutinib, and Acalabrutinib

Primary outcomes

  1. Patient characteristics of those receiving BTKi treatment

    Time frame: up to one year

    Describe the patient characteristics of those receiving BTKi treatment, including age, gender, etc

Secondary outcomes

  1. overall response rate

    Time frame: up to one year

    Assessed according to the iwCLL2018 criteria

  2. Incidence of adverse reactions

    Time frame: up to one year

    Assessed according to the CTCAE 5.0 criteria

Study contacts

Contact information is provided by the study sponsor or research team.

Huayuan Zhu, MD

CONTACT

[email protected]

025-58530260

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 18, 2024
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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