Ignite Creation Date:
2024-05-06 @ 9:55 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03114683
Status:
COMPLETED
Last Update Posted:
2020-12-07
First Post:
2017-04-04
Brief Title:
Efficacy and Safety Evaluation of IBI308 in Treatment of Patients With RelapsedRefractory Classical Hodgkins Lymphoma
Sponsor:
Innovent Biologics Suzhou Co Ltd
Organization:
Innovent Biologics Suzhou Co Ltd
Study Overview
Official Title:
Efficacy and Safety Evaluation of IBI308 in Treatment of Patients With RelapsedRefractory Classical Hodgkins Lymphoma a Multicenter Single Arm Phase II Study
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORIENT-1
Brief Summary:
The study is to evaluate ORR CR PR DCR DOR PFS and safety of IBI308 in treatment of patients with RelapsedRefractory Hodgkins Lymphoma
Detailed Description:
Patients with classical Hodgkin lymphomacHL who relapse after autologous stem-cell transplantationASCT or progress after multiple lines of chemotherapy have a poor prognosis with a median survival of approximately 12 years
CHL frequently harbors a spectrum of chromosome 9p241PD-L1PD-L2 alterations leading to overexpression of the programmed death 1 ligandsPD-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 relapsedrefractory Hodgkin lymphoma in China in 2018
This study is a single armphase 2 study designed to evaluate the clinical activity of sintilimab in Chinese patients with RR
CHL frequently harbors a spectrum of chromosome 9p241PD-L1PD-L2 alterations leading to overexpression of the programmed death 1 ligandsPD-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 relapsedrefractory Hodgkin lymphoma in China in 2018
This study is a single armphase 2 study designed to evaluate the clinical activity of sintilimab in Chinese patients with RR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None