Large B-cell Lymphoma
Conditions
Keywords
Relmacabtagene Autoleucel, Chimeric antigen receptor T cells
Brief summary
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
Detailed description
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.
Interventions
BIOLOGICALRelmacabtagene Autoleucel
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
Sponsors
Shanghai Ming Ju Biotechnology Co., Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients with established r/r LBCL; 2. Patients already treated with commercially available Relmacabtagene Autoleucel
Exclusion criteria
No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 6 months | Percentage of participants with CR or PR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CRR | 6 months | Complete response rate |
| DOR | 6 months | Duration of response |
| Progression-Free Survival (PFS) | 6 months | 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. |
| Overall Survival (OS) | 6 months | OS is defined as the time from Relmacabtagene Autoleucel infusion to the date of death from any cause. |
| Adverse events (AEs) | 6 months | Types, frequency, and severity of adverse events and laboratory anomalies Physiological parameter |
Countries
China
Contacts
Primary ContactMedical JWCAR029, PhD
Backup ContactWeili Zhao, PhD
Outcome results
None listed