Ofatumumab as part of reduced intensity conditioning in high risk B-cell lymphoma patients: final long-term analysis from a prospective multicenter Phase-II Trial

Autores de IIS La Fe

• Isidro Jarque Ramos

  Autor

• Jaime Sanz Caballer

  Autor

Participantes ajenos a IIS La Fe

• Cabrero M
• López-Corral L
• de la Cruz-Vicente F
• Pérez-López E
• Valcárcel D
• Espigado I
• Ortí G
• Martín-Calvo C
• de la Serna J
• Caballero D
• Grupo Español de Trasplante Hematopoyético (GETH) and Grupo Español de Linfomas

Grupos

• Hematología y Hemoterapia

Abstract

Curative potential of allogeneic transplantation (AlloSCT) in high-risk non-Hodgkin lymphoma (NHL) could be enhanced by the integration of Ofatumumab (OFA), a 2nd generation anti-CD20 moAb, due to an antitumor effect and a role over graft-versus-host disease (GVHD). In this phase II trial (NCT01613300), we investigated safety and effectiveness of OFA-based reduced intensity conditioning (RIC). High-risk B-cell NHL patients with chemorrefractory disease or post-autologous SCT relapse were eligible. OFA was added to a standard RIC regimen. Primary endpoint was grade 3-4 aGVHD rate, while secondary endpoints included CR and survival rates. Thirty-three patients were included (median age 51; diffuse large B-cell:68%, HLA-identical donor: 74%). No grade >2 OFA toxicity was observed. Acute GVHD affected 77% of patients (16% grade 3-4). Remarkably, GVHD achieved CR in 75% of patients after first-line treatment. Chronic GVHD, primarily mild or moderate, occurred in 54% of patients. NHL CR rate at day +100 was 81%. Relapses occurred in 7 patients after a median of 3 months. Causes of death were lymphoma progression (5), infections (10), and GVHD (2). At 24 months, progression-free and overall survival rates were 50.1 and 51.6% respectively. OFA-RIC regimen is safe and effective, though acute GVHD remains a significant complication. However, data suggest that OFA could mitigate its severity.

© 2023. The Author(s), under exclusive licence to Springer Nature Limited.

Keywords

• VERSUS-HOST-DISEASE; CHRONIC GVHD; ALLOGENEIC TRANSPLANTATION; RITUXIMAB; BLOOD; SURVIVAL; CRITERIA; HODGKIN