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Trial Title:
Relmacabtagene Autoleucel in Patients With LBCL
NCT ID:
NCT06142175
Condition:
Large B-cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Conditions: Keywords:
Relmacabtagene Autoleucel
Chimeric antigen receptor T cells
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Biological
Intervention name:
Relmacabtagene Autoleucel
Description:
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
Arm group label:
Relmacabtagene Autoleucel
Other name:
JWCAR029
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.
Criteria for eligibility:
Study pop:
r/r LBCL
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Adult patients with established r/r LBCL;
2. Patients already treated with commercially available Relmacabtagene Autoleucel
Exclusion Criteria:
No
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,
Address:
City:
Shanghai
Zip:
200025
Country:
China
Status:
Recruiting
Contact:
Last name:
Weili Zhao, PhD
Start date:
December 28, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Shanghai Ming Ju Biotechnology Co., Ltd.
Agency class:
Industry
Source:
Shanghai Ming Ju Biotechnology Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06142175