The primary objective of this study is to evaluate the efficacy of tislelizumab in participants with relapsed or refractory classical Hodgkin lymphoma (cHL), as measured by Progression-free Survival (PFS) as assessed by investigator
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
200 mg administered via intravenous (IV) infusion once every 3 weeks
Salvage chemotherapy administered as assessed as appropriate by the investigator in accordance with the local guideline, including but not limited to DHAP (dexamethasone, cisplatin, high-dose cytarabine), ESHAP (etoposide, methylprednisolone, high-dose cytarabine and cisplatin), DICE (dexamethasone, ifosfamide, carboplatin, etoposide), ICE (ifosfamide, carboplatin, etoposide), IGEV (ifosfamide, gemcitabine, vinorelbine, prednisone), GVD (gemcitabine, vinorelbine, liposomal doxorubicin), and MINE (etoposide, ifosfamide, mesna, mitoxantrone)
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Quanzhou First Affliated Hospital of Fujian Medical University
Quanzhou, Fujian, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Progression-free Survival (PFS) by Investigator
Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first
Time frame: Up to 45 months
Duration of Response (DOR) by Investigator
The time from the date that response criteria are first met to the date that PD is objectively documented or death, whichever occurs first
Time frame: Up to 45 months
Overall Response Rate (ORR) by Investigator
The proportion of participants who achieves a best overall response of complete response (CR) or partial response (PR)
Time frame: Up to 45 months
Rate of Complete Response (CR) by Investigator
The proportion of participants who achieves a best overall response of CR
Time frame: Up to 45 months
Time to Response (TTR) by Investigator
Time from the date of randomization to the time the response criteria are first met
Time frame: Up to 45 months
Overall survival (OS)
Defined as the time from the date of randomization to the date of death due to any reason
Time frame: Up to 45 months
Number of participants experiencing Adverse Events (AEs)
Time frame: Up to 45 months
Number of participants experiencing Serious Adverse Events (SAEs)
Time frame: Up to 45 months
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Hunan Cancer Hospital
Changsha, Hunan, China
Jilin Cancer Hospital
Changchun, Jilin, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China