Cellular Immunotherapy for Relapsed or Refractory Lymphoma Data Collection

Recruiting

• Conditions: Lymphoma, Non-Hodgkin
• Interventions: Drug: Chimeric Antigen Receptor

• Registration Number: NCT06541327
• Lead Sponsor: Ruijin Hospital

Brief Summary

This study aims to collect clinical data from adult patients with relapsed or refractory non-Hodgkin's lymphoma (r/r NHL) receiving cellular immunotherapy to establish a large database of cellular immunotherapy for Chinese patients.

Detailed Description

This study aims to collect efficacy and safety data from adult patients with r/r NHL who received cellular immunotherapy between January 2017 and December 2040. Study investigators will determine the most appropriate diagnostic and treatment plans for patients based on clinical practice, without any intervention due to the existence of this study. No grouping will be conducted, and subgroup analyses will be performed based on the collected data.

Data collection process:

Clinical data will be collected from patients before cellular immunotherapy, before immune cell infusion, on the day of infusion, and at the last visit or follow-up within 24 months post-infusion. This includes collecting efficacy data, adverse events related to cellular immunotherapy, and survival data. Additionally, any new tumors, pathological findings, and other relevant laboratory or auxiliary examination data will be collected.

Study Timeline

• Study Start: 2024-05-15
• Study First Submitted: 2024-07-30
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-06
• Study First Posted: 2024-08-07
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19
• Primary Completion: 2040-12-31
• Study Completion: 2040-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Adult patients with a confirmed diagnosis of r/r B-NHL (including r/r DLBCL, r/r FL, r/r MCL, HGBL-NOS, FL3b, r/r MZL, transformed lymphomas such as MCL) and r/r T-cell lymphoma, who have received informed consent waivers;
• Patients who have received or are receiving cellular immunotherapy, with cellular immunotherapy products including the following categories: cytokine-induced killer cell therapy (CIK), tumor-infiltrating lymphocytes (TIL), cytokine-induced killer cell-dendritic cell mixed therapy (DC-CIK), chimeric antigen receptor T cells, NK cells or macrophage therapy (CAR-T, CAR-NK, CAR-M), T-cell receptor chimeric T cell therapy (TCR-T), dendritic cell therapy.

Exclusion Criteria

• NA

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CAR-T	Chimeric Antigen Receptor	Chimeric antigen receptor modified T cells

Primary Outcome Measures

Name	Time	Method
Complete Response (CR) Rate in 3 months	3 months post CAR-T infusion	Complete Response rate in 3 months is defined as the incidence of subjects achieving complete remission (CR) within 3 months after CAR-T infusion according to the Lugano Classification (Cheson et al, 2014), as determined by study investigators.

Secondary Outcome Measures

Name	Time	Method
Adverse events (AEs)	2 years post CAR-T infusion	Types, frequency, and severity of adverse events and laboratory anomalies Physiological parameter
Overall Survival (OS)	2 years post CAR-T infusion	OS is defined as the time from CAR-T infusion to the date of death from any cause.
Objective remission rate (ORR) in 3months	3 months post CAR-T infusion	ORR in 3 moths is defined as the incidence of either a CR or a partial response (PR) within 3 months after CAR-T infusion per the Lugano Classification as determined by study investigators.

Trial Locations

Locations (1)

Department of Hematology, Shanghai Institute of Hematology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China