CClinicalTrials.gg
Not yet recruitingNCT06489184Updated Jul 5, 2024

The Real World Study of Zanubrutinib in the Treatment of Chronic Lymphocytic Leukemia in China

An observational study in CLL, sponsored by Peking University People's Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-05.

Sponsored by Peking University People's Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
490
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

03

In context

Leukemia, Lymphoid

1,780 studies on the registry are indexed under Leukemia, Lymphoid; 176 are open to participants now.

This study's planned enrollment of 490 is above the median of 112 across 227 observational studies indexed under Leukemia, Lymphoid.

Browse Leukemia, Lymphoid studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Investigators participating in this observational study should include all patients with CLL who initiated treatment with zanubrutinib over the period from July 1st, 2020 to the present, regardless of the treatment status at the time of inclusion. Thus, at the time of enrolment and retrospective data collection, patients may still be on treatment or have stopped treatment for any reason.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
490 participants (estimated)
Patient registry
No

Interventions

  • DrugZanubrutinib

    patients with treatment naive or R/R CLL who treatment with Zanubrutinib

06

What researchers measure

Primary outcomes

  1. Progression Free Survival (PFS)

    PFS is defined as the duration from date of Zanubrutinib initiation to date of disease progression (PD \[according to the physician's evaluation\]) or death from any cause

    Time frame: up to two years

Secondary outcomes

  1. Overall Survival

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

    Time frame: up to two years

  2. Time to Next Therapy (TTNT)

    The TTNT will be calculated as the difference between Zanubrutinib initiation date and initiation date of the first next therapy for CLL

    Time frame: up to two years

  3. Adverse Events

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

    Time frame: up to two years

07

Study locations

1 site
  • Peking University People's Hospital
    Beijing, Beijing 100044, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06489184
Lead sponsor
Peking University People's Hospital
Responsible party
Xiao-Jun Huang (Prof., Peking University People's Hospital) — Principal investigator
First posted
Jul 5, 2024
Start date
Aug 1, 2024 (estimated)
Primary completion
Jun 1, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Jul 5, 2024

Study contacts

Shenmiao Yang
Contact
yangshenmiao@hotmail.com

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion