NCT03114683

Efficacy and Safety Evaluation of IBI308 in Treatment of Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma

Efficacy and Safety Evaluation of IBI308 in Treatment of Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma: a Multicenter, Single Arm, Phase II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is to evaluate ORR, CR, PR DCR DOR PFS and safety of IBI308 in treatment of patients with Relapsed/Refractory Hodgkin's Lymphoma.

Detailed description

Patients with classical Hodgkin lymphoma(cHL) who relapse after autologous stem-cell transplantation(ASCT) or progress after multiple lines of chemotherapy have a poor prognosis, with a median survival of approximately 1.2 years. CHL frequently harbors a spectrum of chromosome 9p24.1/PD-L1/PD-L2 alterations, leading to overexpression of the programmed death 1 ligands,PD-L1 and PD-L2. Sintilimab is a humanized monoclonal antibody against PD-1 that blocks the interaction between PD-1 and its ligands and was approved for relapsed/refractory Hodgkin lymphoma in China in 2018. This study is a single arm,phase 2 study designed to evaluate the clinical activity of sintilimab in Chinese patients with R/R

Conditions

• Relapsed/Refractory Classical Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	PD1	IBI308 200mg/3 weeks

Timeline

• Start date: 2017-03-30
• Primary completion: 2019-09-12
• Completion: 2019-11-30
• First posted: 2017-04-14
• Last updated: 2020-12-07
• Results posted: 2020-12-07

Locations

1 site across 1 country: China