Actively Recruiting

Phase 4
Age: 18Years - 70Years
All Genders
NCT06609304

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

Led by Zhengzhou University · Updated on 2024-10-15

20

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Understand and voluntarily sign the informed consent form
  • Age between 18 and 70 years inclusive
  • Previously untreated CD19-positive large B-cell lymphoma
  • Anticipated survival of at least 12 weeks
  • Adequate bone marrow reserve before apheresis
  • Appropriate organ function
  • Eastern Cooperative Oncology Group (ECOG) Physical Status Score of 0 or 1
  • No central nervous system lymphoma
  • Negative blood or urine pregnancy test in women of childbearing age
Not Eligible

You will not qualify if you...

  • History of allergy to any 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 hematopoietic agonists/stimulants
  • History of a live vaccine within 3 months prior to screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Zhengzhou University, Department of Oncology

Zhengzhou, Henan, China, 450052

Actively Recruiting

Loading map...

Research Team

Z

Zhang, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here