The primary objective of this study is to evaluate the efficacy of GLS-010 in participants with relapsed or refractory classical Hodgkin lymphoma (R/R cHL), as measured by Progression-free Survival (PFS) as assessed by IRRC
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Participants receive GLS-010 240mg intravenously (IV) on Day 1, Q2W
Chemotherapy administered as assessed as appropriate by the investigator in accordance with the local guideline, including but not limited to DHAP,GEMOX, ESHAP , ICE , IGEV and GVD
Progression Free Survival (PFS) assessed by Independent Radiologic Review Committee (IRRC) per Lugano Classification 2014
Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first.
Time frame: Up to 2 years
Overall Survival (OS)
Defined as the time from the date of randomization to the date of death due to any Defined as the time from the date of randomization to the date of death due to any reason
Time frame: Up to 2 years
Objective Response Rate (ORR)
ORR defined as the proportion of subjects who achieves a best overall response of CR or PR based on Lugano 2014 classification.
Time frame: Up to 2 years
Disease Control Rate (DCR)
DCR defined as the proportion of subjects' response of CR, PR, or SD based on Lugano Classification 2014.
Time frame: Up to 2 years
Duration of Response (DoR)
Up to 2 years
Time frame: DoR defined as the time from the date that CR or PR are first occurred to the date of objective disease progression or death, whichever occurs first
Time to Response (TTR)
Up to 2 years
Time frame: TTR defined as the time from the date of randomization to the date when the response criteria are first met, based on Lugano Classification 2014
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