A Practical Clinical Study Comparing the Fixed-cycle Regimen Containing Orelabrutinib With BTKi Monotherapy
Phase 2
Not yet recruiting
- Conditions
- CLL/SLL
- Interventions
- Registration Number
- NCT06476899
- Lead Sponsor
- Fei Li
- Brief Summary
Prospective, interventional, and practical clinical studies
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fixed regimen FCR/BR orelabrutinib + FCR/BR Fixed regimen orelabrutinib orelabrutinib + FCR/BR Control BTK inhibitor BTKi chosen by doctors
- Primary Outcome Measures
Name Time Method TTNTD rate at 30 months 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
- Secondary Outcome Measures
Name Time Method PFS 3 years The time from the start of treatment to the point when the disease progression or death is confirmed by the investigator