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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 BTK Inhibitor in the Treatment of Chronic Lymphocytic Leukemia in China

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06557304
Enrollment
1000
Registered
2024-08-16
Start date
2024-09-01
Completion date
2027-12-30
Last updated
2024-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CLL

Brief summary

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

Interventions

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

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 BTK inhibitor; 4. Prior or current use of BTK inhibitor for ≥3 months 5. At least one follow-up was recorded during BTK inhibitor treatment

Design outcomes

Primary

MeasureTime frameDescription
Overall Survivalup to five yearsOS is defined as the time from the starting date of BTK inhibitor to the date of death due to any cause.

Secondary

MeasureTime frameDescription
Time to Next Therapy (TTNT)up to two yearsThe TTNT will be calculated as the difference between BTK inhibitor initiation date and initiation date of the first next therapy for CLL
Adverse Eventsup to five yearsPercentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Special Situations

Contacts

Primary ContactShengmiao Yang, MD
yangshenmiao@hotmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026