NCT05334238

Orelabrutinib Maintenance Therapy After ASCT in Primary Central Nervous System Lymphoma

A Multi Center, Randomized, Controlled Clinical Study of the Efficacy and Safety of Orelabrutinib Maintenance Therapy After ASCT in Patients With Primary Central Nervous System Lymphoma

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, randomized, prospective clinical study of the efficacy and safety of Orelabrutinib maintenance therapy after Autologous Stem Cell Transplantation (ASCT) in patients with primary central nervous system lymphoma.

Detailed description

This trial was designed as a multicenter, randomized controlled, prospective clinical study. To evaluate the efficacy and safety of Orelabrutinib maintenance therapy with ASCT in patients with primary lymphoma of the central nervous system in a prospective clinical study. 174 patients were enrolled in this study, and randomly divided into Orelabrutinib maintenance group experimental group or observation group (control group) by 1:1. The trial included a screening period (day -28 to day -1), a treatment period (oral administration of Orelabrutinib 150mg daily for 1 year, beginning 8 weeks after autologous transplantation), and a follow-up period (1 year after the end of the last treatment).

Conditions

• Primary Central Nervous System Lymphoma

Interventions

Type	Name	Description
DRUG	Orelabrutinib	oral administration of Orelabrutinib 150mg daily for 1 year, beginning 8 weeks after autologous transplantation

Timeline

• Start date: 2021-12-01
• Primary completion: 2024-05-30
• Completion: 2025-05-30
• First posted: 2022-04-19
• Last updated: 2022-04-19

Locations

1 site across 1 country: China