CLL/SLL
Conditions
Brief summary
Prospective, interventional, and practical clinical studies
Interventions
DRUGorelabrutinib
orelabrutinib tablets
DRUGFCR/BR
FCR/BR
DRUGBTK inhibitor
BTK inhibitor choose by physican
Sponsors
Fei Li
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| PFS | 3 years | The time from the start of treatment to the point when the disease progression or death is confirmed by the investigator |
Outcome results
None listed