NCT05398224

R-MTX-zanbrutinib in Secondary CNS Lymphoma

Phase II Study of Zanubrutinib in Combination With Rituximab and Methotrexate, Followed by Zanubrutinib Maintenance in Patients With Secondary Central Nervous System Lymphoma (SCNSL)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Secondary Central Nervous System Lymphoma

Interventions

Type	Name	Description
DRUG	Zanubrutinib, high-dose methotrexate (HD-MTX), rituximab	Induction therapy: Zanubrutinib will be given as 160mg bid orally between days 1 and 14 of each 14-day cycle; rituximab will be given at 375mg/m2 intravenously on day 1 of each cycle; methotrexate at 3.5g/m2 for patients ≤65 or 1.5g/m2 for patients \>65 (standard hydration/leucovorin support) will be given intravenously on day 2 of each 14-day cycle; for 6 cycles. Consolidation therapy: For patients ≤65, autologous hematopoietic stem cell transplantation (ASCT with a conditioning regimen of thiotepa/carmustine) will be given as consolidation treatment after induction therapy. Maintenance therapy:Drug: zanubrutinib. Zanubrutinib will be given as 160mg bid orally continuously until progression of the disease (PD), intolerable toxicity, death, or patient/investigator discretion.

Timeline

• Start date: 2021-02-26
• Primary completion: 2024-02-26
• Completion: 2024-05-26
• First posted: 2022-05-31
• Last updated: 2022-05-31

Locations

1 site across 1 country: China