Using Axicabtagene Ciloleucel to improve outcomes after initial treatment for high-risk Large B-cell Lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of Axicabtagene Ciloleucel (axi-cel) as a consolidation therapy following first-line treatment in patients with high-risk Large B-cell Lymphoma (LBCL). Participants will receive a one-time infusion of axi-cel and will be monitored for clinical benefits and safety throughout the treatment process. The study will assess whether this therapy can prolong patient outcomes and identify any associated medical issues during treatment. It is an investigator-initiated, single-arm trial conducted at a single institution.

Why it matters

Who can join: the full rules

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;.

Where it's running

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

Study contacts

• Study coordinator: Zhang, PhD
• Email: fcczhangxd@zzu.edu.cn
• Phone: 86-0371-66279567

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.