The purpose of this study is to evaluate the safety and efficacy of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
IBI318, 300mg, Q2W, Intravenous influsion.
Sun Yat-sen University Cancer Center
Guangdong, China
ORR(evaluated by the independent review committee according to Lyric 2016 criteria.)
To evaluate the objective response rate (ORR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type).
Time frame: After the last subject completed follow-up visit of up to 24 weeks
ORR
To evaluate the objective response rate (ORR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type) determined by the investigators according to Lugano 2014 criteria and Lyric 2016 criteria
Time frame: After the last subject completed follow-up visit of up to 24 weeks
CR/PR
To evaluate the complete response (CR) rate and partial response (PR) rate of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
Time frame: After the last subject completed follow-up visit of up to 24 weeks
DCR
To evaluate the disease control rate (DCR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
Time frame: After the last subject completed follow-up visit of up to 24 weeks
TTR2016 criteria.)
To evaluate the time to response (TTR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
Time frame: After the last subject completed follow-up visit of up to 24 weeks
DOR
To evaluate the duration of response (DOR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
Time frame: After the last subject completed follow-up visit of up to 24 weeks
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PFS
To evaluate the progression-free survival (PFS) and PFS rate at 12 months of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
Time frame: After the last subject completed follow-up visit of up to 24 weeks
OS(evaluated by the investigators according to Lugano 2014 criteria and Lyric 2016 criteria.)
To evaluate the overall survival (OS) and OS at 12 months of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
Time frame: After the last subject completed follow-up visit of up to 24 weeks
adverse events
To evaluate the safety profile of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
Time frame: from enrollment until the last patient finishes OS follow-up, or finishes 24-month treatment and corresponding safety follow-up, whichever comes first.