CLL/SLLPhase 2NCT06476899
A Practical Clinical Study Comparing the Fixed-cycle Regimen Containing Orelabrutinib With BTKi Monotherapy
A Phase 2 study testing orelabrutinib, FCR/BR and BTK inhibitor in people with CLL/SLL, run by Fei Li.
Trial summary
Prospective, interventional, and practical clinical studies Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- CLL/SLL
- What is being tested?
- orelabrutinib, FCR/BR and BTK inhibitor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 24 Jul 2024to 26 Dec 2026
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years, with no gender restrictions;
- Patients with CLL/SLL who meet the iwCLL2018 diagnostic criteria;
- Indications for treatment
- ECOG performance score of 0-2;
- Patients are untreated or have not received standardized treatment
- Before the trial screening, the subject or their legal representative voluntarily signs a written informed consent form, indicating that they understand the purpose of the study and the necessary research steps, and are able to comply with the protocol and follow-up.
Who cannot join
- Has been diagnosed or treated for malignancies other than CLL (including active central nervous system lymphoma) within the past year;
- there is clinical evidence of Richter transformation;
- Participant cannot receive or plan to receive another treatment during study participation
- Other conditions that the investigator considers inappropriate for participation
About this study
Official title: A Practical Clinical Study Comparing the Fixed-cycle Regimen Containing Orelabrutinib With BTKi Monotherapy in Previously Untreated CLL/SLL
Prospective, interventional, and practical clinical studies
- Conditions
- CLL/SLL
- Being tested
- orelabrutinib, FCR/BR, BTK inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orelabrutinibDrug
orelabrutinib tablets
FCR/BRDrug
FCR/BR
BTK inhibitorDrug
BTK inhibitor choose by physican
| Study group | Role | What they receive |
|---|---|---|
| Fixed regimen | Experimental | orelabrutinib + FCR/BR Receives: Drug: orelabrutinib; Drug: FCR/BR |
| Control | Active comparator | BTKi chosen by doctors Receives: Drug: BTK inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
TTNTD rate at 30 months
The proportion of time from the start of treatment to the start of the next treatment or death over a period of 30 months
Measured: 30 months
Secondary outcomes (1)
PFS
The time from the start of treatment to the point when the disease progression or death is confirmed by the investigator
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start24 Jul 2024 (estimated)
- Primary completion26 Mar 2026 (estimated)
- Study completion26 Dec 2026 (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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fei Li, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476899
- Sponsor's protocol ID
- PragmatiCLL
- Status last verified
- Jun 2024
- First submitted
- 19 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- 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 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Practical Clinical Study Comparing the Fixed-cycle Regimen Containing Orelabrutinib With BTKi Monotherapy in Previously Untreated CLL/SLL
- ClinicalTrials.gov ID
- NCT06476899
- Acronym / sponsor ID
- PragmatiCLL
- Conditions
- CLL/SLL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fei LiUniversity, hospital or other
- Study start
- 24 Jul 2024 (estimated)
- Primary completion
- 26 Mar 2026 (estimated)
- Study completion
- 26 Dec 2026 (estimated)
- First posted
- 27 Jun 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.
Prospective, interventional, and practical clinical studies
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed regimen | Experimental | Drug: orelabrutinib, Drug: FCR/BRorelabrutinib + FCR/BR |
| Control | Active comparator | Drug: BTK inhibitorBTKi chosen by doctors |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 70 years, with no gender restrictions;
- Patients with CLL/SLL who meet the iwCLL2018 diagnostic criteria;
- Indications for treatment
- ECOG performance score of 0-2;
- Patients are untreated or have not received standardized treatment
Key exclusion criteria (4 listed)
- Has been diagnosed or treated for malignancies other than CLL (including active central nervous system lymphoma) within the past year;
- there is clinical evidence of Richter transformation;
- Participant cannot receive or plan to receive another treatment during study participation
- Other conditions that the investigator considers inappropriate for participation
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 |
|---|---|---|
| orelabrutiniborelabrutinib tablets | Drug | Fixed regimen |
| FCR/BRFCR/BR | Drug | Fixed regimen |
| BTK inhibitorBTK inhibitor choose by physican | Drug | Control |
Primary outcome
TTNTD rate at 30 months
Time frame: 30 months
The proportion of time from the start of treatment to the start of the next treatment or death over a period of 30 months
1 secondary outcome
PFS
Time frame: 3 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 27 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing orelabrutinib, FCR/BR and BTK inhibitor in people with CLL/SLL, run by Fei Li.
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 6 inclusion and 4 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 27 Jun 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TTNTD rate at 30 months (time frame: 30 months). 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 27 Jun 2024.