Follicular Lymphoma, Large B-cell Lymphoma, Lymphoma, B-Cell
Conditions
Keywords
Relmacabtagene Autoleucel, Chimeric antigen receptor T cells
Brief summary
To evaluate the efficacy and safety of Relmacabtagene Autoleucel in the treatment of adult patients with hematologic malignancies in real-world
Detailed description
The purpose of this study is to observationally evaluate the efficacy and safety data of Relmacabtagene Autoleucel for the treatment of patients with hematologic malignancies for up to 15 years after infusion. The treating physician will determine the most appropriate diagnostic and therapeutic regimen for the patient based on clinical practice. No therapeutic intervention will be administered to patients in this study.
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
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent 2. Patients who have been treated with Relma-cel, including those who have received off-label products; 3. If previously enrolled in another clinical study, they must have completed follow-up in the previous study, or have withdrawn or lost follow-up in the previous study.
Exclusion criteria
1.Patients who have been treated with Relma-cel and then have been treated with other CAR-T products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 15 years | Percentage of participants with CR \[CMR;CRR\] or PR \[partial metabolic response (PMR); |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CRR | 15 years | Complete response rate |
| Duration of response (DOR) | 15 years | Time from first response(PR or CR) to disease progression or death from any cause. |
| Progression-Free Survival (PFS) | 15 years | 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) | 15 years | OS is defined as the time from Relmacabtagene Autoleucel infusion to the date of death from any cause. |
| Adverse events (AEs) | 15 years | Types, frequency, and severity of adverse events and laboratory anomalies Physiological parameter |
Countries
China
Contacts
Primary ContactYuqing Song, PhD
Backup ContactMedical JWCAR029
Outcome results
None listed