Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Axicabtagene Ciloleucel.
- Who it may be relevant to
- Registry conditions: Lymphoma, B-Cell. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Clinical Study of Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma
Overview
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.
Interventions
- Biological Axicabtagene Ciloleucel
Axicabtagene Ciloleucel at 2.0×10\^6/Kg
Primary outcome measures
- 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]
Eligibility criteria
Inclusion criteria
- Understand and voluntarily sign the informed consent form;
- 18-70 years of age (inclusive);
- Previously untreated CD19-positive large B-cell lymphoma;
- Anticipated survival ≥12 weeks;
- Adequate bone marrow reserve prior to apheresis
- Appropriate organ function:
- 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
- History of allergy to any of the 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 haematopoietic agonists/stimulants ;
- History of a live vaccine within 3 months prior to screening;.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Zhengzhou University, Department of Oncology — Zhengzhou
Identifiers
NCT: NCT06609304 · TA2024-252