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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03114683
Study type Interventional
Source Innovent Biologics (Suzhou) Co. Ltd.
Contact
Status Completed
Phase Phase 2
Start date March 30, 2017
Completion date November 30, 2019