Efficacy and Safety Evaluation of IBI308 in Treatment of Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma (ORIENT-1)
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|ClinicalTrials.gov Identifier: NCT03114683|
Recruitment Status : Completed
First Posted : April 14, 2017
Results First Posted : December 7, 2020
Last Update Posted : December 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Relapsed/Refractory Classical Hodgkin's Lymphoma||Drug: PD1||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety Evaluation of IBI308 in Treatment of Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma: a Multicenter, Single Arm, Phase II Study|
|Actual Study Start Date :||March 30, 2017|
|Actual Primary Completion Date :||September 12, 2019|
|Actual Study Completion Date :||November 30, 2019|
IBI308 200mg/3 weeks
- Objective Response Rate (ORR) Assessed According to the Revised International Working Group Response Criteria for Malignant Lymphoma in 2007(IWG 2007) by the Independent Radiological Review Committee (IRRC). [ Time Frame: Up to 2 years ]Per Revised International Working Group Response Criteria for Malignant Lymphoma in 2007(IWG 2007) assessed by CT and PET: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), ≥50% decrease in SPD of up to 6 largest dominant masses, no increase in size of other nodes; Overall Response (OR) = CR + PR
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114683
|Cancer hospital Chinese academy of Medical sciences|