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)
Single group
Axicabtagene Ciloleucel
DrugTreatment consists of a single dose for infusion containing a dispersion for infusion of CAR-positive viable T cells in one infusion bag. The target dose is 2 × 106 CAR-positive viable T cells per kg of body weight (within a range of 1 × 106 - 2 × 106 cells/kg), with a maximum of 2 × 108 CAR-positive viable T cells for patients 100 kg and above.
Response month 3
The Complete Metabolic Response, defined as negative findings on a PET/CT scan at month 3 after receiving axicabtagene ciloleucel infusion at day 0. The negativity of PET/CT findings will be assessed according to Lugano Classification and Deauville criteria
Response month 3 central
The Complete Metabolic Response defined as negative findings on a PET/CT scan at month3 after receving axicabtagene ciloleucel infusion as assessed by central imaging review of PET/CT
Overall response rate
The Overall response rate (ORR) defined as the percentage of patients who achieved partial metabolic response (PMR) or complete metabolic response (CMR) according to the Lugano Classification criteria at month 3 determined by both central and investigator assessments.
Best objective response
Best objective response rate defined as the percentage of CMR + PMR determined by the investigator assessment among all patients between month 1 and month 12 from axicabtagene ciloleucel infusion
Best complete response rate
Best Complete Response rate defined as the percentage of CMR determined by the investigator assessment among all patients between month 1 and month 12 from axicabtagene ciloleucel infusion
Total Metabolic Tumor
Correlation between Total Metabolic Tumor Volume (TMTV) pre-axicabtagene ciloleucel infusion and efficacy/toxicity
Phenotypic expression of lineage and checkpoint markers in tumor
Histologic, phenotypic, genomic, transcriptomic, and molecular characteristics of Expression of CD19, CD20, CD79a, PD-L1 and other protocol-specified markers assessed by IHC or immunofluorescence on tumor tissue pre- and post-treatment.
Cytokine levels
Concentrations of predefined cytokines (e.g., IL-6, IFN-γ, TNF-α) measured in serum pre-treatment and at specified post-treatment time points.Unit of Measure: Picograms per milliliter (pg/mL).
Minimal residual disease
Minimal residual disease assessment by ctDNA
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Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Lead sponsor
Kite, A Gilead Company
Collaborator
Evidenze CRO
Collaborator
