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 Zanubrutinib in the Treatment of Chronic Lymphocytic Leukemia in China

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Key information

Conditions

CLL

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients aged ≥18 years old
Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) requiring treatment (iwCLL [International Workshop on Chronic Lymphocytic Leukemia] criteria)；
Treatment-naïve OR Refractory Recurrence CLL patients who were initiated on BTK inhibitor;
Prior or current use of BTK inhibitor for ≥3 months
At least one follow-up was recorded during BTK inhibitor treatment

Treatment and study plan

BTK inhibitor

Drug

patients with treatment naive or R/R CLL who treatment with BTK inhibitor

Primary outcomes

Overall Survival

Time frame: up to five years

OS is defined as the time from the starting date of BTK inhibitor to the date of death due to any cause.

Secondary outcomes

Time to Next Therapy (TTNT)

Time frame: up to two years

The TTNT will be calculated as the difference between BTK inhibitor initiation date and initiation date of the first next therapy for CLL
Adverse Events

Time frame: up to five years

Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Special Situations

Study contacts

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

Shengmiao Yang, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2027
First posted: Aug 16, 2024
Registry last updated: Aug 21, 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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