This is a prospective, multicenter, real-world study to evaluate the efficacy and safety of pirtobrutinib in patients with mature B-cell lymphoma who are resistant or intolerant to prior covalent BTK inhibitors. The primary endpoint is overall response rate (ORR). Secondary endpoints include best overall response (BOR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety. A total of 40 patients will be enrolled across 8 centers in China.
This prospective, multicenter, observational real-world study enrolls 40 patients with histologically confirmed mature B-cell lymphoma who have failed or are intolerant to at least one covalent BTK inhibitor. Patients receive pirtobrutinib 200 mg once daily until disease progression or unacceptable toxicity. Efficacy is assessed per Lugano 2014, iwCLL 2018, and IWWM-11 criteria. Safety is evaluated using CTCAE v5.0. The primary outcome is ORR. Secondary outcomes include BOR, DOR, PFS, OS, and safety profile.
Study Type
OBSERVATIONAL
Enrollment
40
Pirtobrutinib 200 mg administered orally once daily, in accordance with standard clinical practice, until disease progression, unacceptable toxicity, or study completion.
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
ORR
Overall Response Rate
Time frame: 24months
BOR
Best Overall Response
Time frame: 24 months
DOR
Duration of Response
Time frame: 24 months
PFS
Progression-Free Survival
Time frame: 24 months
OS
Overall Survival
Time frame: 24 months
Number of participants with treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0
Incidence, severity (graded per CTCAE v5.0), and causality of all adverse events (AEs), serious adverse events (SAEs), and treatment-related adverse events (TRAEs) from the first dose of pirtobrutinib to 30 days after the last dose.
Time frame: 24 months
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