This is a multicenter, single-arm, phase II study to evaluate the efficacy and safety of CS1001 monotherapy for Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma (ENKTL)
Eligible subjects with rr-NKTL after prior asparaginase-based chemotherapy or chemo radiotherapy are planned to receive CS1001 1200 mg intravenous infusion every three weeks until progression of disease, intolerable toxicity, consent withdrawn, death. The primary endpoint of this trial is objective response rate (ORR), as assessed by independent radiological review committee (IRRC) based on Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
monoclonal antibody
Peking University Third Hospital
Beijing, China
Hunan Cancer Hospital
Changsha, China
West China Hospital of Sichuan University
Objective Response Rate (ORR) Assessed by IRRC
ORR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Time frame: From enrollment to end of follow-up, a median of 29 months
Objective Response Rate (ORR) Assessed by Investigators
ORR assessed by investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Time frame: From enrollment to end of follow-up, a median of 29 months
Complete Response Rate (CRR) by Investigators
CRR assessed by investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Time frame: From enrollment to end of follow-up, a median of 29 months
Complete Response Rate (CRR) Assessed by IRRC
CRR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Time frame: From enrollment to end of follow-up, a median of 29 months
Partial Response Rate (PRR) Assessed by Investigators
PRR assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Time frame: From enrollment to end of follow-up, a median of 29 months
Partial Response Rate (PRR) Assessed by IRRC
PRR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Time frame: From enrollment to end of follow-up, a median of 29 months
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Chengdu, China
Fujian Cancer Hospital
Fuzhou, China
Sun Yat-sen University Cancer Prevention Center
Guangzhou, China
Guizhou Cancer Hospital
Guiyang, China
The First Affiliated Hospital of Zhejiang University
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Anhui Cancer Hospital
Hefei, China
Cancer Hospital Affiliated to Guangxi Medical University
Nanning, China
...and 7 more locations
Duration of Response (DoR) Assessed by Investigators
DoR assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Time frame: From enrollment to end of follow-up, a median of 29 months
Duration of Response (DoR) Assessed by IRRC
DoR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Time frame: From enrollment to end of follow-up, a median of 29 months
Time to Response (TTR) Assessed by Investigators
TTR assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Time frame: From enrollment to end of follow-up, a median of 29 months
Time to Response (TTR) Assessed by IRRC
TTR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Time frame: From enrollment to end of follow-up, a median of 29 months
Number of Participants With Adverse Events
Time frame: From enrollment to end of follow-up, a median of 29 months