NCT05021770

Orelabrutinib in Combination With Thiotepa in Refractory and Relapsed Primary CNS Lymphoma

Safety and Efficacy of Orelabrutinib（O） in Combination With Thiotepa（T） in Refractory and Relapsed Primary CNS Lymphoma： A Single-arm, Multicenter Phase Ib/II Study（OT）

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Huiqiang Huang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to investigate the maximum tolerated dose and efficacy of Orelabrutinib combined with Thiotepa in refractory and relapsed primary central nervous system lymphoma (PCNSL).

Conditions

• Refractory and Relapsed Primary CNS Lymphoma
• PCNSL
• Non Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Orelabrutinib	150mg or 200mg orally daily
DRUG	Orelabrutinib	RP2D
DRUG	Thiotepa	30 mg/m2 intravenously every 3 weeks (maximum 6 cycle)

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-12-01
• Completion: 2024-06-01
• First posted: 2021-08-26
• Last updated: 2021-08-26

Locations

1 site across 1 country: China