Clinical trial · Interventional
Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma
Prospective Clinical Study of Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axicabtagene Ciloleucel | Biological | Axicabtagene Ciloleucel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- axi-cel treatment
- interventionNames
- Biological: Axicabtagene Ciloleucel
Primary outcomes (1)
- measure
- one year PFS
- timeFrame
- 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
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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;.
References
Publications (0)
Data not yet available