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RecruitingNCT07874451Updated Oct 14, 2026

Real-World Study of BCL-2 Inhibitor-Based Regimens in Chronic Lymphocytic Leukemia

An observational study in CLL / SLL, sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Observational

Updated Oct 14, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study summary

This non-interventional, real-world cohort study aims to evaluate treatment patterns, clinical outcomes, and safety of BCL-2 inhibitor-based regimens in patients with CLL treated in routine clinical practice. Data collected from participating centers will be used to characterize patient demographics, disease characteristics, treatment exposure, effectiveness outcomes, and adverse events, thereby providing real-world evidence to support clinical decision-making and optimize patient management.

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Conditions studied

  • CLL / SLL

Keywords

  • BCL2i
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In context

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 563 studies on the registry; 311 are open to participants now.

Browse The First Affiliated Hospital with Nanjing Medical University studies →

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

The study population consists of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) treated in routine clinical practice. Eligible patients must have received at least one BCL-2 inhibitor-based treatment regimen and have available baseline demographic, clinical, molecular, and laboratory data, as well as at least one evaluable follow-up record. The study includes patients treated in both frontline and relapsed/refractory settings to evaluate the real-world effectiveness, safety, and treatment patterns of BCL-2 inhibitor-based therapies.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18 years at the time of enrollment;
  • Confirmed diagnosis of CLL or SLL according to the 2018 iwCLL criteria;
  • Prior or ongoing treatment with a BCL-2 inhibitor-based regimen;
  • Availability of complete key baseline data (e.g., demographic characteristics, disease stage, molecular genetic features, and relevant laboratory parameters) and at least one evaluable post-treatment follow-up record, including effectiveness assessment, safety evaluation, or survival data.

Exclusion criteria

Exclusion Criteria:

  • Patients with significant missing key baseline information or treatment exposure data, rendering evaluation of effectiveness or safety outcomes not feasible.
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
300 participants (estimated)
Patient registry
No

Interventions

  • DrugNot applicable- observational study

    not applicable for non-interventional study

06

What researchers measure

Primary outcomes

  1. TTNT

    Time frame: 4 years

  2. PFS

    Time frame: 4 years

07

Study locations

1 of 1 sites recruiting
  • Jiangsu Province Hospital
    Nanjing, Jiangsu 210000, China
    Recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Oct 2030, 48 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2026
First posted
Oct 14, 2026
StartEst.
Oct 2026
Primary completionEst.
Oct 2030
CompletionEst.
Oct 2030
Last update
Oct 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 14, 2026
Show all 1 update
  1. Oct 14, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07874451
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Responsible party
Sponsor
First posted
Oct 14, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2030 (estimated)
Completion
Oct 2030 (estimated)
Last update
Oct 14, 2026

Study contacts

Huayuan ZHU
Contact
huayuan.zhu@hotmail.com
+86-13813810650

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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