RecruitingPhase 4NCT06609304

Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma

Prospective Clinical Study of Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma


Sponsor

Zhengzhou University

Enrollment

20 participants

Start Date

Sep 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if Axicabtagene Ciloleucel (axi-cel) works for consolidation after first-line treatment of high-risk Large B-cell Lymphoma (LBCL). It will also learn about the safety of axi-cel treatment. The main questions it aims to answer are: * Does axi-cel treatment result in prolonged clinical benefit to patients with high-risk LBCL after first-line treatment? * What medical problems do participants have when receiving axi-cel treatment? In this investigator-initiated, single-arm clinical trial, participants will: * Receive atezolizumab treatment at 2.0×10\^6 cells/Kg as a one-time therapy. * Visit the clinic as instructed for checkups and tests.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether a CAR-T cell therapy called axicabtagene ciloleucel (Yescarta) can be used as a "consolidation" treatment after first-line chemotherapy for patients with high-risk large B-cell lymphoma (an aggressive blood cancer). CAR-T therapy involves re-engineering a patient's own immune cells to attack cancer. Researchers want to see if using it early prevents relapse. **You may be eligible if...** - You are between 18 and 70 years old - You have been newly diagnosed with large B-cell lymphoma that tests positive for CD19 - You have not been treated for this lymphoma before - You are in good physical condition (ECOG 0 or 1) - Your organs and bone marrow are functioning adequately **You may NOT be eligible if...** - You have had a prior stem cell or organ transplant - You have active infections - Your lymphoma has spread to the brain or central nervous system - You have received prior CAR-T or modified T-cell therapy - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAxicabtagene Ciloleucel

Axicabtagene Ciloleucel at 2.0×10\^6/Kg


Locations(1)

The First Affiliated Hospital of Zhengzhou University, Department of Oncology

Zhengzhou, Henan, China

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NCT06609304


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