NCT05518318

GLS-010 Monotherapy Versus Chemotherapy in Patients With Relapsed or Refractory Classical Hodgkin's Lymphoma (R/R cHL)

Evaluate the Efficacy and Safety of GLS-010 Versus Chemotherapy Assessed by Investigator in Patients With Relapsed or Refractory Classical Hodgkin's Lymphoma (R/R cHL) in a Randomized, Open, Multicenter Phase III Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Guangzhou Gloria Biosciences Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy of GLS-010 in participants with relapsed or refractory classical Hodgkin lymphoma (R/R cHL), as measured by Progression-free Survival (PFS) as assessed by IRRC

Conditions

• Classic Hodgkin's Lymphoma
• Recurrent Classic Hodgkin Lymphoma
• Refractory Classic Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	GLS-010	Participants receive GLS-010 240mg intravenously (IV) on Day 1, Q2W
DRUG	Chemotherapy of Investigator's choice	Chemotherapy administered as assessed as appropriate by the investigator in accordance with the local guideline, including but not limited to DHAP,GEMOX, ESHAP , ICE , IGEV and GVD

Timeline

• Start date: 2022-09-01
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2022-08-26
• Last updated: 2022-08-26