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

Phase 4

Recruiting

• Conditions: Lymphoma, B-Cell
• Interventions: Biological: Axicabtagene Ciloleucel

• Registration Number: NCT06609304

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-08-28
• Study First Submitted QC: 2024-09-21
• Study First Posted: 2024-09-24
• Study Start: 2024-09-30
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-11
• Primary Completion: 2026-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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;

8. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
axi-cel treatment	Axicabtagene Ciloleucel	-

Primary Outcome Measures

Name	Time	Method
one year PFS	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

Trial Locations

Locations (1)

The First Affiliated Hospital of Zhengzhou University, Department of Oncology; 🇨🇳 Zhengzhou, Henan, China