Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma
Recruiting now · Phase 4
Conditions studied: Lymphoma, B-Cell
In brief
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.
Key facts
- Study ID
- NCT06609304
- Run by
- Zhengzhou University
- People needed
- 20
- Starts
- 2024-09-30
- Expected to finish
- 2027-08-31
- Last updated by the study team
- 2024-10-15
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
- Negative blood/urine pregnancy test in women of childbearing age.
You may not qualify if…
- 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;.
Where it is running
- The First Affiliated Hospital of Zhengzhou University, Department of Oncology — Zhengzhou, Henan, China (enrolling)
Full record on ClinicalTrials.gov
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