This is a single-arm, open-label, multicenter clinical study evaluating the efficacy and safety of pirtobrutinib combined with Pola-R-CHP in previously untreated Non-GCB DLBCL. PET/CT assessment will be performed after 3 cycles of combination therapy. Patients achieving CR/PR will continue treatment for another 3 cycles, while those with PD/SD will be discontinued from the study. Patients achieving CR/PR after 6 cycles of treatment will undergo follow-up with PET/CT or contrast-enhanced CT every 3 months during the first year and every 6 months thereafter, until disease progression, death, withdrawal of informed consent, or study completion, whichever occurs first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Pirtobrutinib 200 mg once daily Polatuzumab vedotin 1.8 mg/kg intravenously on Day 1 Rituximab 375 mg/m² on Day 1 Cyclophosphamide 750 mg/m² on Day 1 Doxorubicin 50 mg/m² on Day 1 Prednisone 100 mg on Days 1 to 5 Each cycle lasts 21 days. PET/CT evaluation is conducted after 3 treatment cycles. Subjects who attain CR or PR will receive an additional 3 cycles of therapy. Subjects with PD or SD will be withdrawn from the study. Subjects who do not achieve CR or PR upon completion of 6 cycles will be withdrawn from the study.
Jiangsu Province Hospital The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
2-year progression-free survival (PFS) rate
Time frame: 2 years
Objective Response Rate (ORR) after 6 cycles of induction therapy
Time frame: week 18,at the end of 6 cycles of induction therapy(each cycle is 21 days)
Complete Response Rate (CRR) after 6 cycles of induction therapy
Time frame: week 18, at the end of 6 cycles of induction therapy(each cycle is 21 days)
Overall Survival(OS)
Time frame: up to 4 years
Number of participants with treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0
Time frame: up to 4 years
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