CLL/SLLNCT06508684
Current Status of BTKi Treatment for CLL/SLL in China
An observational study of CLL/SLL, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
BTKi has become the standard treatment regimen for CLL/SLL，there is a lack of large-scale real-world studies on the use status and related influencing factors of BTK inhibitors. Therefore, we plan to conduct this multicenter retrospective cross-sectional study to understand the current situation of BTK inhibitor… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- CLL/SLL
- What is being tested?
- BTK inhibitor
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 13 Jul 2024to 12 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CLL/SLL Patient who receiving BTKi treatment
Who may be able to join
- Age ≥ 18 years;
- Patients with a confirmed diagnosis of CLL/SLL;
- Received BTK inhibitor treatment between February 2023 and February 2024.
Who cannot join
- Patients with other types of lymphoma;
- Cases deemed unsuitable for inclusion in this study by the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Nanjin, Jiangsu, 210029
Huayuan Zhu, PhD，MD, 86 25 68306034, huayuan.zhu@hotmail.com
About this study
Official title: Current Status and Influencing Factors of Chinese Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Undergoing Treatment With Bruton's Tyrosine Kinase Inhibitors
BTKi has become the standard treatment regimen for CLL/SLL，there is a lack of large-scale real-world studies on the use status and related influencing factors of BTK inhibitors. Therefore, we plan to conduct this multicenter retrospective cross-sectional study to understand the current situation of BTK inhibitor treatment for CLL/SLL patients in China and the related influencing factors, and to explore more suitable treatment patterns based on this.
- Conditions
- CLL/SLL
- 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
BTKi can refer to Orelabrutinib, Ibrutinib, Zanubrutinib, and Acalabrutinib
| Study group | Role | What they receive |
|---|---|---|
| BTK inhibitor treated | investigate the current situation of BTK inhibitor treatment for CLL/SLL patients in China and the related influencing factors, including the efficacy and safety, the drug swith between different BTKis，the BTKi based timed limited therapy, etc Receives: Drug: BTK inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient characteristics of those receiving BTKi treatment
Describe the patient characteristics of those receiving BTKi treatment, including age, gender, etc
Measured: up to one year
Secondary outcomes (2)
overall response rate
Assessed according to the iwCLL2018 criteria
Measured: up to one year
Incidence of adverse reactions
Assessed according to the CTCAE 5.0 criteria
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start13 Jul 2024
- Primary completion12 Feb 2025 (estimated)
- Study completion12 Jul 2025 (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.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508684
- Sponsor's protocol ID
- PICASSO
- Status last verified
- Jul 2024
- First submitted
- 14 Jul 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Current Status and Influencing Factors of Chinese Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Undergoing Treatment With Bruton's Tyrosine Kinase Inhibitors
- ClinicalTrials.gov ID
- NCT06508684
- Acronym / sponsor ID
- PICASSO
- Conditions
- CLL/SLL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 13 Jul 2024 (actual)
- Primary completion
- 12 Feb 2025 (estimated)
- Study completion
- 12 Jul 2025 (estimated)
- First posted
- 18 Jul 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.
BTKi has become the standard treatment regimen for CLL/SLL，there is a lack of large-scale real-world studies on the use status and related influencing factors of BTK inhibitors. Therefore, we plan to conduct this multicenter retrospective cross-sectional study to understand the current situation of BTK inhibitor treatment for CLL/SLL patients in China and the related influencing factors, and to explore more suitable treatment patterns based on this.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BTK inhibitor treated | – | Drug: BTK inhibitorinvestigate the current situation of BTK inhibitor treatment for CLL/SLL patients in China and the related influencing factors, including the efficacy and safety, the drug swith between different BTKis，the BTKi based timed limited therapy, etc |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CLL/SLL Patient who receiving BTKi treatment
Key inclusion criteria (3 listed)
- Age ≥ 18 years;
- Patients with a confirmed diagnosis of CLL/SLL;
- Received BTK inhibitor treatment between February 2023 and February 2024.
Key exclusion criteria (2 listed)
- Patients with other types of lymphoma;
- Cases deemed unsuitable for inclusion in this study by the investigators.
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 inhibitorBTKi can refer to Orelabrutinib, Ibrutinib, Zanubrutinib, and Acalabrutinib | Drug | BTK inhibitor treated |
Primary outcome
Patient characteristics of those receiving BTKi treatment
Time frame: up to one year
Describe the patient characteristics of those receiving BTKi treatment, including age, gender, etc
2 secondary outcomes
overall response rate
Time frame: up to one year
Incidence of adverse reactions
Time frame: up to one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huayuan Zhu, MD (025-58530260, huayuan.zhu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient characteristics of those receiving BTKi treatment (time frame: up to one year). 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 18 Jul 2024.