NCT05896007

Zanubrutinib Combined With Rituximab and Chemotherapy for Newly-Diagnosed PCNSLBCL Patients Intolerant to HSCT

Zanubrutinib Combined With Rituximab and Chemotherapy for Newly-Diagnosed Primary Central Nervous System Large B-Cell Lymphoma Patients Intolerant to Haematopoietic Stem Cell Transplantation

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This single-center, open, single-arm study aim to evaluate the efficacy and tolerability of a therapy introducing zanubrutinib on the basis of rituximab and methotrexate (MTX) \[or temozolomide (TMZ), if intolerant to MTX\] in treating patients newly diagnosed with primary CNS large B-cell lymphoma and intolerant to HSCT.

Detailed description

Participants will receive zanubrutinib in addition to first-line therapy consisting of rituximab and either MTX or TMZ. After treatment of 6 cycles with the new regimen, the patients achieving CR or PR would go on to receive zanubrutinib maintenance of 1 year (if tolerable).

Conditions

• PCNSL

Interventions

Type	Name	Description
DRUG	Zanubrutinib	160 mg bid po, until disease progression, intolerance of drug toxicity or death, otherwise maintaining during the 1st year in 2 years of follow-up
DRUG	Rituximab	375 mg/m\^2 ivgtt, D0 of each 28-day cycle
DRUG	Methotrexate	3.5 g/m\^2 ivgtt, D1 of each 28-day cycle
DRUG	Temozolomide	150 mg/m\^2 ivgtt, D1-D5 of each 28-day cycle

Timeline

• Start date: 2023-07-13
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-06-09
• Last updated: 2023-09-05

Locations

1 site across 1 country: China