CLL/SLLNCT05975164
the Real World Study of Orelabrutinib in the Treatment of CLL/SLL
An observational study of CLL/SLL, run by Shandong University.
Trial summary
This is a Multicenter, Retrospective Real-world Study of Orelabrutinib in the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in China Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CLL/SLL
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2023to 10 Jul 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who received orelabrutinib in real world
Who may be able to join
- Age ≥18 years old
- Patients with a definite diagnosis of CLL/SLL
- Prior or current use of orelabrutinib for ≥3 months
- At least one follow-up was recorded during orelabrutinib treatment
Who cannot join
- 1.Patients who received orelabrutinib in a prospective clinical trial
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Retrospective Real-world Study of Orelabrutinib in the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
This is a Multicenter, Retrospective Real-world Study of Orelabrutinib in the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in China
Read the detailed description
Orelabrutinib is a novel BTK inhibitor with high selectivity and has been approved in China for relapsed/refractory CLL/SLL,, The purpose of this study is to describe the effectiveness and safety of orelabrutinib of chronic lymphocytic leukemia (CLL) in real world.
- Conditions
- CLL/SLL
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
The ORR will be calculated as the proportion of participants who achieve either complete response (CR), partial response (PR) or partial response with lymphocytosis, as assessed by the participating physician.
Measured: up to two years
Secondary outcomes (4)
Time to Next Therapy (TTNT)
The TTNT will be calculated as the difference betweenorelabrutinib initiation date and initiation date of the first next therapy for CLL
Measured: up to two years
Progression Free Survival (PFS)
PFS is defined as the duration from date of orelabrutinib initiation to date of disease progression (PD [according to the physician's evaluation]) or death from any cause
Measured: up to two years
response rate of Hematologic Parameters
the proportion of participants who had abnormal baseline hemoglobin, or platelet, or lymphocyte counts returned to normal levels or had ≥50% increases in hemoglobin and platelets or ≥50% decreases in lymphocyte counts
Measured: up to two years
safety
Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Special Situations
Measured: up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start25 Jul 2023 (estimated)
- Primary completion10 Dec 2023 (estimated)
- Study completion10 Jul 2024 (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
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunyan Ji, Shandong University
- Investigators
- Chunyan Ji, Dr., Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975164
- Sponsor's protocol ID
- Orelabrutinib in real world
- Status last verified
- Jul 2023
- First submitted
- 26 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Real-world Study of Orelabrutinib in the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- ClinicalTrials.gov ID
- NCT05975164
- Acronym / sponsor ID
- Orelabrutinib in real world
- Conditions
- CLL/SLL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 25 Jul 2023 (estimated)
- Primary completion
- 10 Dec 2023 (estimated)
- Study completion
- 10 Jul 2024 (estimated)
- First posted
- 3 Aug 2023 (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 Orelabrutinib in the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in China
Detailed description
Orelabrutinib is a novel BTK inhibitor with high selectivity and has been approved in China for relapsed/refractory CLL/SLL,, The purpose of this study is to describe the effectiveness and safety of orelabrutinib of chronic lymphocytic leukemia (CLL) in real world.
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
- Patients who received orelabrutinib in real world
Key inclusion criteria (4 listed)
- Age ≥18 years old
- Patients with a definite diagnosis of CLL/SLL
- Prior or current use of orelabrutinib for ≥3 months
- At least one follow-up was recorded during orelabrutinib treatment
Key exclusion criteria (1 listed)
- 1.Patients who received orelabrutinib in a prospective clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Response Rate (ORR)
Time frame: up to two years
The ORR will be calculated as the proportion of participants who achieve either complete response (CR), partial response (PR) or partial response with lymphocytosis, as assessed by the participating physician.
4 secondary outcomes
Time to Next Therapy (TTNT)
Time frame: up to two years
Progression Free Survival (PFS)
Time frame: up to two years
response rate of Hematologic Parameters
Time frame: up to two years
safety
Time frame: up to two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: Undecided
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RecruitingObservational study
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RecruitingPhase 3
A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).
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RecruitingPhase 1
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Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
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.
Chunyan Ji, Dr. principal investigator
Qilu Hospital of Shandong University
Questions about this trial
What is this clinical trial studying?
An observational study of CLL/SLL, run by Shandong University.
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: status not confirmed, as of the sponsor's last update on 3 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Li (18560089739, liwei_medicine@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: up to two 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 3 Aug 2023.