NCT05253118

Relapsed or Refractory Primary Diffuse Large B-cell Lymphoma (DLBCL) of the Central Nervous System (CNS)

Phase II Study of Tislelizumab Plus Pemetrexed in Patients With Relapsed or Refractory Primary Diffuse Large B-cell Lymphoma (DLBCL) of the Central Nervous System (CNS)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Relapsed or refractory primary DLBCL of the CNS

Detailed description

This is a multi-center, open label, single arm, phase 2 study designed to evaluate efficacy and safety of tislelizumab (BGB-A317) in combination with pemetrexed in patients with R/R primary DLBCL of the CNS. Twenty-eight patients will be enrolled. Eligible participants will receive combination treatment until disease progression, unacceptable toxicity, or withdrawal of informed consent.

Conditions

• DLBCL

Interventions

Type	Name	Description
DRUG	Tislelizumab	Tislelizumab (BGB-A317) 200mg will be administered on Day 1 of each 21-day cycle (once every 3 weeks) in combination with pemetrexed.
DRUG	Pemetrexed	Pemetrexed 500 mg/m2 will be administered on Day 1 of each 21-day cycle (once every 3 weeks).

Timeline

• Start date: 2022-08-18
• Primary completion: 2025-12-31
• Completion: 2026-02-28
• First posted: 2022-02-23
• Last updated: 2025-05-15

Locations

1 site across 1 country: South Korea