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RecruitingNCT06609304axi-celUpdated Oct 15, 2024

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

A Phase 4 interventional study of Axicabtagene Ciloleucel in Lymphoma, B-Cell, sponsored by Zhengzhou University. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by Zhengzhou University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Lymphoma, B-Cell
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 20 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Zhengzhou University is the lead sponsor of 28 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion criteria

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;.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    axi-cel treatment

    Biological: Axicabtagene Ciloleucel

Interventions

  • BiologicalAxicabtagene Ciloleucel

    Axicabtagene Ciloleucel at 2.0×10\^6/Kg

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital of Zhengzhou University, Department of Oncology
    Zhengzhou, Henan 450052, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06609304
Lead sponsor
Zhengzhou University
Responsible party
Mingzhi Zhang (Professor, Zhengzhou University) — Principal investigator
First posted
Sep 24, 2024
Start date
Sep 30, 2024 (estimated)
Primary completion
Aug 31, 2026 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Oct 15, 2024

Study contacts

Zhang, PhD
Contact
fcczhangxd@zzu.edu.cn
86-0371-66279567

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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