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

October 9, 2024 updated by: Mingzhi Zhang, Zhengzhou University

Prospective Clinical Study of 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University, Department of Oncology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Understand and voluntarily sign the informed consent form;
  2. 18-70 years of age (inclusive);
  3. Previously untreated CD19-positive large B-cell lymphoma;
  4. Anticipated survival ≥12 weeks;
  5. Adequate bone marrow reserve prior to apheresis
  6. Appropriate organ function:
  7. Eastern Cooperative Oncology Group (ECOG) Physical Status Score of 0 or 1; 8. Absence of CNS lymphoma;

9. Negative blood/urine pregnancy test in women of childbearing age.

Exclusion Criteria:

  1. History of allergy to any of the components of the cell product;
  2. History of stem cell transplantation;
  3. History of organ transplantation;
  4. Presence of active infections;
  5. Current or history of central nervous system disorders;
  6. Previous treatment with other modified T-cell therapy;
  7. Previous treatment with anti-CD19/CD3 or other anti-CD19 therapies;
  8. Malignancies other than those indicated for this trial;
  9. History of any prior systemic immune checkpoint therapy;
  10. History of short-acting cell growth factors or haematopoietic agonists/stimulants ;
  11. History of a live vaccine within 3 months prior to screening;.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: axi-cel treatment
Biological: Axicabtagene Ciloleucel
Axicabtagene Ciloleucel at 2.0×10^6/Kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhengzhou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

August 28, 2024

First Submitted That Met QC Criteria

September 21, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 9, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TA2024-252

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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