To evaluate the efficacy and safety of Relmacabtagene autoleucel for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma (LBCL) in real-world
This is a post-marketing, multicenter, observational real-world study, including prospective and retrospective studies. The purpose of this study is to collect efficacy and safety data over a 6-month period following treatment of adult patients with r/r LBCL with Relmacabtagene autoleucel. The treating physicians in the study will determine the most appropriate diagnostic and therapeutic regimen for their patients based on clinical practice.There will be no therapeutic intervention as a result of this study. There will be no subgroups of any kind in this study, and subgroup analyses will be performed based on the actual data collected during the analysis.
Study Type
OBSERVATIONAL
Enrollment
200
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,
Shanghai, Shanghai Municipality, China
RECRUITINGORR
Percentage of participants with CR or PR
Time frame: 6 months
CRR
Complete response rate
Time frame: 6 months
DOR
Duration of response
Time frame: 6 months
Progression-Free Survival (PFS)
PFS is defined as the time from the Relmacabtagene Autoleucel infusion date to the date of disease progression per Lugano classification or death from any cause.
Time frame: 6 months
Overall Survival (OS)
OS is defined as the time from Relmacabtagene Autoleucel infusion to the date of death from any cause.
Time frame: 6 months
Adverse events (AEs)
Types, frequency, and severity of adverse events and laboratory anomalies Physiological parameter
Time frame: 6 months
Weili Zhao, PhD
CONTACT
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