NCT06508684

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 13, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 14, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2025

Completed
Last Updated

July 18, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

July 14, 2024

Last Update Submit

July 14, 2024

Conditions

CLL/SLL

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • overall response rate

    up to one year

  • Incidence of adverse reactions

    up to one year

Study Arms (1)

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

Interventions

BTK inhibitorDRUG

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

BTK inhibitor treated

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CLL/SLL Patient who receiving BTKi treatment

You may qualify if:

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

You may not qualify if:

  • Patients with other types of lymphoma;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nanjin, Jiangsu, 210029, China

RECRUITING

Central Study Contacts

Huayuan Zhu, MD

CONTACT

025-58530260huayuan.zhu@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2024

First Posted

July 18, 2024

Study Start

July 13, 2024

Primary Completion

February 12, 2025

Study Completion

July 12, 2025

Last Updated

July 18, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)