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NCT Number: NCT06609304

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

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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First Affiliated Hospital of Zhengzhou University, Department of Oncology

Zhengzhou, Henan, 450052, China

Location status: Recruiting

Location contact

Xudong Zhang, PhD

CONTACT

[email protected]

86-0371-66279567

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • Adequate bone marrow reserve prior to apheresis
  • Appropriate organ function:
  • Eastern Cooperative Oncology Group (ECOG) Physical Status Score of 0 or 1; 8. Absence of CNS lymphoma;
  • Negative blood/urine pregnancy test in women of childbearing age.

Exclusion criteria

  • 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;
  • Current or history of central nervous system disorders;
  • Previous treatment with other modified T-cell therapy;
  • Previous treatment with anti-CD19/CD3 or other anti-CD19 therapies;
  • Malignancies other than those indicated for this trial;
  • History of any prior systemic immune checkpoint therapy;
  • History of short-acting cell growth factors or haematopoietic agonists/stimulants ;
  • History of a live vaccine within 3 months prior to screening;.

Treatment and study plan

Axicabtagene Ciloleucel

Biological

Axicabtagene Ciloleucel at 2.0×10^6/Kg

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Zhengzhou University

Other

Registry information

Official study title

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

Acronym: axi-cel

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 24, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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