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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorZhengzhou University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Understand and voluntarily sign the informed consent form;

18-70 years of age (inclusive);

Previously untreated CD19-positive large B-cell lymphoma;

Anticipated survival ≥12 weeks;

Disqualifiers

History of allergy to any of the components of the cell product;

History of stem cell transplantation;

History of organ transplantation;

Presence of active infections;

Trial design

Design model

Single group

Treatments tested in this trial

  • Axicabtagene Ciloleucel

    Biological/Vaccine

    Axicabtagene Ciloleucel at 2.0×10\^6/Kg

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: axi-cel treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

one year PFS

Time frame
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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