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NOT YET RECRUITING
NCT07812493
PHASE2

Pirtobrutinib Plus Methotrexate-Based Chemoimmunotherapy for Systemic DLBCL With CNS Involvement

Sponsor: Pengpeng Xu

View on ClinicalTrials.gov

Summary

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.

Official title: Efficacy and Safety of Methotrexate (MTX) Combined With Chemoimmunotherapy Plus Pirtobrutinib in Patients With Systemic Diffuse Large B-Cell Lymphoma (DLBCL) and Central Nervous System Involvement

Key Details

Gender

All

Age Range

14 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-09-01

Completion Date

2030-09-01

Last Updated

2026-09-10

Healthy Volunteers

No

Interventions

DRUG

pirtobrutinib+MTX+immunolchemotherapy

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.

Locations (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China