Not yet recruiting NCT06476899
A Practical Clinical Study Comparing the Fixed-cycle Regimen Containing Orelabrutinib With BTKi Monotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: orelabrutinib, FCR/BR, BTK inhibitor.
- Who it may be relevant to
- Registry conditions: CLL/SLL. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Practical Clinical Study Comparing the Fixed-cycle Regimen Containing Orelabrutinib With BTKi Monotherapy in Previously Untreated CLL/SLL
Overview
Prospective, interventional, and practical clinical studies
Interventions
- Drug orelabrutinib
orelabrutinib tablets - Drug FCR/BR
FCR/BR - Drug BTK inhibitor
BTK inhibitor choose by physican
Primary outcome measures
- TTNTD rate at 30 months [Time frame: 30 months]
Secondary outcome measures (1)
- PFS [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06476899 · PragmatiCLL