Study to Evaluate the Efficacy of Axicabtagene Ciloleucel in Patients With Late Relapse of Diffuse Large B-Cell Lymphoma
This study tests a specialized cell therapy called axicabtagene ciloleucel in patients whose lymphoma has returned after previous treatment. Your immune cells will be collected, modified in a laboratory to fight cancer, and then infused back into your body. You will be monitored for up to 5 years to see how well this treatment works.
Key Objective: This trial is testing whether this engineered cell therapy can help patients whose diffuse large B-cell lymphoma has returned after initial treatment.
Who to Consider: Patients with diffuse large B-cell lymphoma that has relapsed or returned after previous treatment should consider this trial.
Trial Parameters
Brief Summary
Single-arm, open-label, multicenter, phase II trial aiming to include approximately 45 patients over 24 months. Patients will receive axicabtagene ciloleucel infusion and will be followed up to 5 years. The total duration of the study is therefore of 7 years.
Eligibility Criteria
Inclusion Criteria: 1. Signed written Informed Consent Form 2. Age \> 18 years 3. Patient who understands and speaks one of the country official languages 4. Histologically proven relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (B-NHL) of the following histology at relapse: diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL) and follicular lymphoma Grade 3B per WHO 2016 classification. Indolent B-NHL who transformed into aggressive B-NHL and were previously treated with R-CHOP-like after transformation are eligible. Primary mediastinal B-cell lymphoma are not eligible. 5. Positron-emission tomography (PET)-positive disease 6. Patients must have received adequate first-line therapy including at a minimum: * An anti-CD20 monoclonal antibody (rituximab or obinutuzumab), and * CHOP or CHOP-like chemotherapy Note: CHOP-like chemotherapy corresponds to ACVBP, EPOCH, or COPADEM. Dose-reduced CHOP (i.e., miniCHOP) is excluded except for dose-reductions of vin