NCT04789434

PD-1 Inhibitor Tislelizumab Maintenance Therapy in Newly Diagnosed DLBCL Patients After ASCT

PD-1 Inhibitor Tislelizumab Maintenance Therapy in Newly Diagnosed DLBCL Patients After ASCT: A Multicenter, Randomized Controlled Clinical Study on Efficacy and Safety

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized controlled, prospective clinical trial. The objective is to investigate the efficacy and safety of Tislelizumab maintenance therapy in newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients after autologous hematopoietic stem cell transplantation (ASCT).

Detailed description

This is a multicenter, randomized controlled, prospective clinical trial. The objective is to investigate the efficacy and safety of Tislelizumab maintenance therapy in newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients after autologous hematopoietic stem cell transplantation (ASCT). 94 patients were randomly divided into two groups according to the ratio of 1:1. The whole trial included screening period (day-28 to day-1), treatment period (Tislelizumab, 200mg every 8 weeks, 12 times) and follow-up period (2 years after the enrollment).

Conditions

• Lymphoma, Large B-Cell, Diffuse
• Transplantation
• Chemotherapy

Interventions

Type	Name	Description
DRUG	PD-1 Inhibitor Tislelizumab maintenance therapy	PD-1 Inhibitor Tislelizumab maintenance therapy, 200mg, every 2 months, 12 times

Timeline

• Start date: 2021-07-09
• Primary completion: 2023-07-01
• Completion: 2024-07-01
• First posted: 2021-03-09
• Last updated: 2021-11-22

Locations

1 site across 1 country: China