NCT04899570

Zanubrutinib Combined With R-CHOP in Newly-diagnosed Intravascular Large B-cell Lymphoma

A Prospective Phase II Study of Zanubrutinib Combined With R-CHOP in Newly-diagnosed Intravascular Large B-cell Lymphoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective single-arm phase II study, and the purpose of this study is to evaluate the efficiency of zanubrutinib combined with R-CHOP regimen in newly diagnosed primary intraocular lymphoma. Progression-free survival (PFS) of the cohort is the primary endpoint.

Detailed description

All the eligible patients will be treated with ZR-CHOP regimen (Rituximab 375mg/m2 IV d1, cyclophosphamide 750mg/m2 IV d1, epirubicin 70mg/m2 IV d1, vindesine 4mg IV d1，prednison 60mg/m2 d1-5 PO). An interim evaluation will be performed after 4 cycles, the patients who achieve CR or PR will receive another 4 cycles of ZR-CHOP. The patients with stable disease (SD) or progressed disease (PD) will withdraw from the trial and receive salvage regimens. During the following-up, surveillance physical examination and CT scans should be performed every 6 months for 2 years to determine the status of disease.

Conditions

• Intravascular Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Zanubrutinib	160mg Bid, oral, d1-21 in a 21-day cycle for 8 cycles.
DRUG	Rituximab	Rituximab 375mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be prescribed as protocol
DRUG	Cyclophosphamide	Cyclophosphamide 750mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be prescribed as protocol
DRUG	Epirubicin	Epirubicin 70mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be prescribed as protocol
DRUG	Vindesine	Vindesine 4mg intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be rescribed as protocol
DRUG	Prednisone	Prednisone 60mg/m2 orally d1-5, every 21 days for 1 cycle. 8 cycles will be rescribed as protocol

Timeline

• Start date: 2021-04-01
• Primary completion: 2023-04-01
• Completion: 2025-04-01
• First posted: 2021-05-24
• Last updated: 2021-05-24

Locations

1 site across 1 country: China