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.
Signed written Informed Consent Form
Age > 18 years
Patient who understands and speaks one of the country official languages
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.
Patients who received more than one prior line of systemic therapy
Early relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven disease relapse before 12 months from end of first-line therapy.
Progressive disease (PD) during first-line therapy
Stable disease (SD) as best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R-CHOP)
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Lead sponsor
Kite, A Gilead Company
Collaborator
Evidenze CRO
Collaborator