Relmacabtagene Autoleucel in Hematologic Malignancies

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of Relmacabtagene Autoleucel in the treatment of adult patients with hematologic malignancies in real-world

Detailed Description
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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.

Official Title
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A Real-world Study for the Treatment of Hematologic Malignancies With Relmacabtagene Autoleucel

Conditions
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Lymphoma, B-Cell, Large B-cell Lymphoma, Follicular Lymphoma

Intervention / Treatment
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* Biological: Relmacabtagene Autoleucel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Patients who have been treated with Relma-cel, including those who have received off-label products; If previously enrolled in another clinical study, they must have completed follow-up in the previous study, or have withdrawn or lost follow-up in the previous study.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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Relmacabtagene Autoleucel<br>Relmacabtagene Autoleucel administered as a single IV infusion at a target dose of 1 x 10^8 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells on Day1. | Biological: Relmacabtagene Autoleucel<br>* A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells<br>* Other names: JWCAR029;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Percentage of participants with CR [CMR;CRR] or PR [partial metabolic response (PMR); | 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRR | Complete response rate | 15 years | 
| Duration of response (DOR) | Time from first response(PR or CR) to disease progression or death from any cause. | 15 years | 
| Progression-Free Survival (PFS) | 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. | 15 years | 
| Overall Survival (OS) | OS is defined as the time from Relmacabtagene Autoleucel infusion to the date of death from any cause. | 15 years | 
| Adverse events (AEs) | Types, frequency, and severity of adverse events and laboratory anomalies Physiological parameter | 15 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relmacabtagene Autoleucel, Chimeric antigen receptor T cells