Clinical trial NCT06142175: Relmacabtagene Autoleucel in Patients With LBCL
Official title: A Real World Study of Treatment of Relmacabtagene Autoleucel in Relapsed or Refractory Large B-Cell Lymphoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Large B-cell Lymphoma
Keywords: Relmacabtagene Autoleucel
Chimeric antigen receptor T cells
Lead sponsor: Shanghai Ming Ju Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: r/r LBCL

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

No

Primary outcomes:
measure: ORR
timeFrame: 6 months
Secondary outcomes:
measure: CRR
timeFrame: 6 months
measure: DOR
timeFrame: 6 months
measure: Progression-Free Survival (PFS)
timeFrame: 6 months
measure: Overall Survival (OS)
timeFrame: 6 months
measure: Adverse events (AEs)
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,
state: Shanghai
Study officials:
affiliation: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,
name: Weili Zhao, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sun Yat-sen University
name: Huiqiang Huang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, China
name: Liang Huang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Tongji Hospital, Tongji University School of Medicine
name: Ping Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuhan Union Hospital, China
name: Heng Mei
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Hongmei Jing
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Wenbin Qian
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Soochow University
name: Depei Wu
role: PRINCIPAL_INVESTIGATOR
affiliation: Ningbo University People's Hospital
name: Ying Lu
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Cancer Hospital
name: Huilai Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Harbin Medical University Tumor Hospital
name: Qingyuan Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Hematology Hospital, Chinese Academy of Medical Sciences
name: Dehui Zou
role: PRINCIPAL_INVESTIGATOR
affiliation: Chongqing University Cancer Hospital
name: Yao Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiangsu Provincial Tumor Hospital
name: Jianqiu Wu
role: PRINCIPAL_INVESTIGATOR
affiliation: Hunan Cancer Hospital
name: Yajun Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Southern Medical University, China
name: Ru Feng
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanfang Hospital, Southern Medical University
name: Yuhua Li
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Xiamen University
name: Zhifeng Li
role: PRINCIPAL_INVESTIGATOR
References: