Recruiting NCT06541327 Last updated by the registry: 2024-08-19

Cellular Immunotherapy for Relapsed or Refractory Lymphoma Data Collection

— Observational Lymphoma, Non-Hodgkin

Why this appeared in your results: Lymphoma, Non-Hodgkin · Recruiting · China

Detailed eligibility, including treatment history and laboratory results, still needs to be checked.

For patients and families

In plain language

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chimeric Antigen Receptor.
Who it may be relevant to
Registry conditions: Lymphoma, Non-Hodgkin. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview

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.

Interventions

  • Drug Chimeric Antigen Receptor
    CAR-T

Primary outcome measures

  • Complete Response (CR) Rate in 3 months [Time frame: 3 months post CAR-T infusion]
Secondary outcome measures (3)
  • Objective remission rate (ORR) in 3months [Time frame: 3 months post CAR-T infusion]
  • Overall Survival (OS) [Time frame: 2 years post CAR-T infusion]
  • Adverse events (AEs) [Time frame: 2 years post CAR-T infusion]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Questions to ask your doctor

  • Is this trial appropriate for my diagnosis and stage?
  • What is known about the study treatment and its risks?
  • Would participation interfere with my current treatment?
  • Which tests are needed to check the eligibility criteria?
  • Are there similar trials closer to home?

What information a coordinator may need

  • the exact diagnosis and stage (briefly, as in the medical report);
  • previous and current treatment with dates;
  • recent tests and reports (CT/MRI/PET, pathology) — when the coordinator asks, not in the first request;
  • age, country of residence and ability to travel;
  • the NCT number of this trial (filled in automatically when you apply from this page).

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Department of Hematology, Shanghai Institute of Hematology, Ruijin Hospital, Shanghai Jiao — Shanghai

Identifiers

NCT: NCT06541327 · CCIC-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗

Ask a coordinator