CLLNCT06557304
The Real World Study of BTK Inhibitor in the Treatment of Chronic Lymphocytic Leukemia in China
An observational study of CLL, run by Peking University People's Hospital.
Trial summary
This is a Multicenter, Retrospective Real-world Study of Zanubrutinib in the Treatment of Chronic Lymphocytic Leukemia in China Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CLL
- What is being tested?
- BTK inhibitor
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Investigators participating in this observational study should include all patients with CLL who initiated treatment with BTK inhibitor over the period from Dec. 1st, 2017 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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Shengmiao Yang, MD contact
About this study
Official title: This is a Multicenter, Retrospective 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
- Conditions
- CLL
- Being tested
- BTK inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTK inhibitorDrug
patients with treatment naive or R/R CLL who treatment with BTK inhibitor
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
OS is defined as the time from the starting date of BTK inhibitor to the date of death due to any cause.
Measured: up to five years
Secondary outcomes (2)
Time to Next Therapy (TTNT)
The TTNT will be calculated as the difference between BTK inhibitor initiation date and initiation date of the first next therapy for CLL
Measured: up to two years
Adverse Events
Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Special Situations
Measured: up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLLStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-Jun Huang, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557304
- Sponsor's protocol ID
- BTKi-CLL-RWE
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This is a Multicenter, Retrospective Real-world Study of BTK Inhibitor in the Treatment of Chronic Lymphocytic Leukemia in China
- ClinicalTrials.gov ID
- NCT06557304
- Acronym / sponsor ID
- BTKi-CLL-RWE
- Conditions
- CLL
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Multicenter, Retrospective Real-world Study of Zanubrutinib in the Treatment of Chronic Lymphocytic Leukemia in China
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Investigators participating in this observational study should include all patients with CLL who initiated treatment with BTK inhibitor over the period from Dec. 1st, 2017 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BTK inhibitorpatients with treatment naive or R/R CLL who treatment with BTK inhibitor | Drug | – |
Primary outcome
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.
2 secondary outcomes
Time to Next Therapy (TTNT)
Time frame: up to two years
Adverse Events
Time frame: up to five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shengmiao Yang, MD contact
Questions about this trial
What is this clinical trial studying?
An observational study of CLL, run by Peking University People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shengmiao Yang, MD (yangshenmiao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: up to five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.