Efficacy and Safety Evaluation of IBI308 in Patients With Extranodal NK/T Cell Lymphoma Patients (ORIENT-4)
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|ClinicalTrials.gov Identifier: NCT03228836|
Recruitment Status : Active, not recruiting
First Posted : July 25, 2017
Last Update Posted : September 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Effect of Drugs||Drug: PD-1 Antibody||Phase 2|
Extranodal NK/T cell lymphoma, nasal type(ENKTL) accounts for about 6% of all lymphomas in china. Epstein Barr virus (EBV) infection is found in all cases of ENKTL and maybe plays an important pathogenetic role.
Conventional anthrocycline-based regimens are not preferred to be used in ENKTL because of high p-glycoprotein expression. ORR of L-asparaginase based regimens is about 80% and no salvage regimens are recommended in ENKTL so far after failure of L-asparaginase based regimen.
Recently, a phase II clinical trial result demonstrated high ORR of anti-PD-1 antibody treatment in ENKTL.IBI308, a humanized monoclonal antibody (mAb) directly against PD-1, is investigated in this phase II Chinese ENKTL clinical trial.
Additionally the correlation between PD-L1 expression and the response to IBI308 treatment in Chinese ENKTL subjects will also be assessed.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety Evaluation of IBI308 in Patients With Relapsed/Refractory Extranodal NK/T Cell Lymphoma, Nasal Type: a Multicenter, Single Arm, Phase 2 Study (ORIENT-4)|
|Actual Study Start Date :||August 31, 2017|
|Actual Primary Completion Date :||February 7, 2018|
|Estimated Study Completion Date :||February 2, 2020|
Drug: PD-1 Antibody
IBI308 200mg/3 weeks
- ORR [ Time Frame: up to 24 months after randomization] ]
ORR(objective response rate):[time frame: up to 24 months after randomization] Objective response is defined as best overall response (CR or PR) across all assessment time points during the period from enrollment to termination of trial treatment(per Lugano 2014 criteria during intial 24 weeks, per IWG 2007 criteria after 24 weeks).
Objective response is defined as best overall response (CR or PR) across all assessment time points during the period from enrollment to termination of trial treatment(per Lugano 2014 criteria during intial 24 weeks, per IWG 2007 criteria after 24 weeks)
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): NCT03228836
|Jiangsu Provincial Hospital|
|Nanjing, Jiangsu, China|
|Principal Investigator:||Yong Ji Li, Master||The First Affiliated Hospital with Nanjing Medical University|