drugset / Trial / NCT07812493

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

NCT07812493 ↗

Phase 2 Not yet recruiting 24 enrolled Pengpeng Xu
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2026-09-01
Primary completion
2028-09-01
Completion
2030-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Methotrexate Small molecule 3500 mg/m2 —
Subject Pirtobrutinib Small molecule 200 mg —
Subject Thiotepa Other / unclassified 30 mg/m2 —
Background Cyclophosphamide Other / unclassified 750 mg/m2 —
Background Doxorubicin Other / unclassified 50 mg/m2 —
Background Polatuzumab Vedotin Other / unclassified 1.8 mg/kg —
Background Prednisone Other / unclassified 100 mg —
Background Rituximab Monoclonal antibody 375 mg/m2 —
Background Vincristine Small molecule 1.4 mg/m2 —