This is an open-label, prospective, single-arm, multicenter study designed to evaluate the efficacy and safety of MTX plus pirtobrutinib combined with routinely-used clinical chemoimmunotherapy regimens in patients with DLBCL and central nervous system (CNS) involvement.
This was an open-label, prospective, single-arm, multicenter study designed to evaluate the efficacy and safety of MTX plus pirtobrutinib combined with conventional clinical chemoimmunotherapy regimens in patients with DLBCL and central nervous system (CNS) involvement. Subjects meeting the inclusion/exclusion criteria were enrolled into the experimental arm after providing written informed consent. Each treatment cycle lasted 3 weeks. Following 6 cycles of induction therapy, subjects who failed to achieve partial response (PR) or experienced disease progression at any time point were withdrawn from the study and received salvage therapy. Subjects achieving complete response (CR) or PR proceeded to autologous stem-cell transplantation if they were young and eligible for transplantation. For patients with stable disease (SD) or progressive disease (PD), subsequent treatment was administered at the investigator's discretion, followed by follow-up observation for up to 3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Induction therapy: Pirtobrutinib 200 mg once daily, combined with MTX (thiotepa for patients intolerant to MTX) plus chemoimmunotherapy regimens. MTX 3.5 g/m² or thiotepa 30 mg/m²; R-CHOP regimen: Rituximab 375 mg/m² Day 0 Cyclophosphamide 750 mg/m² Day 1 Doxorubicin 50 mg/m² Day 1 Vincristine 1.4 mg/m² Day 1 Prednisone 100 mg/day Days 1-5 MTX 3.5 g/m² or thiotepa 30 mg/m²; Pola-R-CHP regimen: Rituximab 375 mg/m² Day 1 Cyclophosphamide 750 mg/m² Day 1 Doxorubicin 50 mg/m² Day 1 Prednisone 100 mg/day Days 1-5 Polatuzumab vedotin 1.8 mg/kg Day 1 Each cycle was 21 days, for a total of 6 cycles. Consolidation therapy: After achieving CR or PR, young and transplant-eligible subjects could receive autologous stem-cell transplantation.
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
CRR(complete remission rate) after 6 cycles of induction therapy
Time frame: Week 18,at the end of induction therapy(each cycle is 21 days)
2-year PFS rate
Time frame: 2 years
overall survival (OS)
Time frame: From first study treatment until death from any cause, up to 4 years
objective response rate (ORR)
Time frame: week 18,at the end of 6 cycles of induction therapy(each cycle is 21 days )
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