NCT05926427

Orelabrutinib Combined With Rituximab and Chemotherapy for Relapsed/Refractory B-Cell Lymphoma Patients With Central Nervous System Involvement

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 14 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 orelabrutinib on the basis of rituximab and chemotherapy in treating patients with relapsed or refractory B-cell lymphoma invloving central nervous system.

Detailed description

Participants will receive orelabrutinib in addition to second-line therapy consisting of rituximab and recommended chemotherapy according to histopathologic type. After treatment of 6 cycles with the new regimen, the patients achieving CR or PR would go on to receive autologous haematopoietic stem cell transplantation (auto-HSCT) with or without orelabrutinib maintenance of 2 years (if tolerable) or orelabrutinib maintenance alone if intolerant to auto-HSCT.

Conditions

• CNS Lymphoma

Interventions

Type	Name	Description
DRUG	Orelabrutinib	150 mg qd po, until disease progression, intolerance of drug toxicity or death, otherwise maintaining during 2 years of follow-up
DRUG	Rituximab	375 mg/m\^2 ivgtt, D0 of each 28-day cycle
DRUG	Chemotherapy	Not specified, recommended regimen according to histopathologic type

Timeline

• Start date: 2023-08-10
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2023-07-03
• Last updated: 2023-09-05

Locations

1 site across 1 country: China