Relmacabtagene Autoleucel in Patients With LBCL

Recruiting

• Conditions: Large B-cell Lymphoma

• Registration Number: NCT06142175
• Lead Sponsor: Shanghai Ming Ju Biotechnology Co., Ltd.

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.

Study Timeline

• Study Start: 2022-12-28
• Status Verified: 2023-11
• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-15
• Study First Posted: 2023-11-21
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Adult patients with established r/r LBCL;
2. Patients already treated with commercially available Relmacabtagene Autoleucel

Exclusion Criteria

No

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ORR	6 months	Percentage of participants with CR or PR

Secondary Outcome Measures

Name	Time	Method
CRR	6 months	Complete response rate
DOR	6 months	Duration of response
Overall Survival (OS)	6 months	OS is defined as the time from Relmacabtagene Autoleucel infusion to the date of death from any cause.
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.
Adverse events (AEs)	6 months	Types, frequency, and severity of adverse events and laboratory anomalies Physiological parameter

Trial Locations

Locations (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,; 🇨🇳 Shanghai, Shanghai, China