To evaluate the efficacy and safety of pirtobrutinib combined with R-CHOP in patients with newly diagnosed non-GCB diffuse large B-cell lymphoma (DLBCL)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
The treatment regimen consists of pirtobrutinib 200 mg orally on days 1-21 of each 21-day cycle for 6 cycles, combined with R-CHOP given as follows: rituximab 375 mg/m² intravenously on day 1; cyclophosphamide 750 mg/m² intravenously on day 2; doxorubicin 50 mg/m² intravenously on day 2; vincristine 1.4 mg/m² (maximum 2 mg) intravenously on day 2 for 6 cycles; and prednisone 100 mg orally on days 1-5 of each 21-day cycle for 6 cycles.
Jiangsu Province Hospital The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
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)
Objective Response Rate (ORR) after 6 cycles of induction therapy
Time frame: week 18,at the end of induction therapy(each cycle is 21 days)
Overall Survival (OS)
Time frame: up to 3 years
Progression-Free Survival(PFS)
Time frame: up to 3 years
Number of participants with treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0
Time frame: up to 3 years
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