CLL / SLLNCT07874451
Real-World Study of BCL-2 Inhibitor-Based Regimens in Chronic Lymphocytic Leukemia
An observational study of CLL / SLL, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CLL / SLL
- What is being tested?
- Not applicable- observational study
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Oct 2030
- 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
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients with significant missing key baseline information or treatment exposure data, rendering evaluation of effectiveness or safety outcomes not feasible.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210000
Huayuan ZHU, +86-13813810650, huayuan.zhu@hotmail.com
About this study
Official title: A Non-Interventional Real-World Cohort Study Evaluating BCL-2 Inhibitor-Based Treatment Regimens for Patients With Chronic Lymphocytic Leukemia (CLL)
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.
- Conditions
- CLL / SLL
- Being tested
- Not applicable- observational study
- Keywords
- BCL2i
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyDrug
not applicable for non-interventional study
What is being measured
The primary outcome is the main question the study is designed to answer.
TTNT
Measured: 4 years
PFS
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLL / SLLStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874451
- Sponsor's protocol ID
- 2026-SR-0109
- Status last verified
- Sep 2026
- First submitted
- 8 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional Real-World Cohort Study Evaluating BCL-2 Inhibitor-Based Treatment Regimens for Patients With Chronic Lymphocytic Leukemia (CLL)
- ClinicalTrials.gov ID
- NCT07874451
- Acronym / sponsor ID
- 2026-SR-0109
- Conditions
- CLL / SLL
- Keywords
- BCL2i
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 14 Oct 2026 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with significant missing key baseline information or treatment exposure data, rendering evaluation of effectiveness or safety outcomes not feasible.
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 |
|---|---|---|
| Not applicable- observational studynot applicable for non-interventional study | Drug | – |
Primary outcome
TTNT
Time frame: 4 years
PFS
Time frame: 4 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 14 Oct 2026.
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Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
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Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia
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Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CLL / SLL, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Huayuan ZHU (+86-13813810650, huayuan.zhu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TTNT (time frame: 4 years). The study lists 2 primary outcomes in all. 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 14 Oct 2026.