FIRST REPORT OF THE REAL-LIFE PROSPECTIVE OBSERVATIONAL STUDY “CAR-T CELL IN DIFFUSE LARGE B-CELL AND PRIMARY MEDIASTINAL LYMPHOMAS” OF THE ITALIAN SOCIETY OF HEMATOLOGY
The Italian Society of Hematology (SIE) conducted a prospective observational trial aimed to:
1) register all DLBCL and PMBCL patients (pts) candidate to CAR-T in the Italian authorized centers;
2) evaluate the intention to treat overall response rate (ORR, complete [CR] and partial response [PR]), duration of response (DOR), progression free survival (PFS) and overall survival (OS);
3) evaluate safety in terms of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS) and long-term cytopenia; 5. evaluate different CAR-T products.
Conclusions: In the real-life, axi-cel and tisa-cel showed an ORR similar to those of the registrative trials, even if almost all pts underwent bridging therapy. The response rate is similar across histotypes and between products. CAR-T toxicity is manageable, relapse beyond 6 months is a rare event. Cytopenias as well as infections are an emerging problem in real-life setting.