drugset / Trial / NCT05398224

R-MTX-zanbrutinib in Secondary CNS Lymphoma

NCT05398224 ↗

Phase 2 Unknown 45 enrolled Peking University
NaSingle-groupOpen-labelTreatment

Summary

Secondary central nervous system lymphoma (SCNSL) occurred in about 5% of patients with diffuse large B-cell lymphoma (DLBCL). The prognosis of SCNSL is very poor. A number of retrospective studies have shown that the median overall survival (mOS) since the diagnosis of CNSL is only 2.5-3.5 months, and the 2-year OS rate is only 20%. At present, there is no consensus on the treatment of SCNSL, and new therapeutic strategies are urgently needed. Zanubrutinib is a new second-generation BTK inhibitor, which has showed good efficacy and safety in a variety of B-NHL. Zanubrutinib has showed good blood-brain barrier permeability in preclinical studies. This study attempts to evaluate the efficacy and safety of zanubrutinib combined with rituximab and high-dose methotrexate in the treatment of SCNSL in patients with DLBCL.

Timeline

Start
2021-02-26
Primary completion
2024-02-26
Completion
2024-05-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Methotrexate Small molecule 1.5 mg/m2 Intravenous
Subject Methotrexate Small molecule 3.5 mg/m2 Intravenous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Zanubrutinib Small molecule 160 mg Oral