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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

Bone Marrow Transplantation volume 59, pages 359–365 (2024)Cite this article

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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.

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Data availability

The datasets analyzed during the current study are available from the corresponding author on reasonable request.

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Author information

Authors and Affiliations

  1. Hospital Universitario de Salamanca-IBSAL, Salamanca, Spain

    Mónica Cabrero, Lucia López-Corral, Estefanía Pérez- López & Dolores Caballero

  2. Hospital Universitario y Politécnico La Fe, Valencia, Spain

    Isidro Jarque & Jaime Sanz

  3. Hospital Universitario Virgen de Rocío, Sevilla, Spain

    Fátima de la Cruz-Vicente & Ildefonso Espigado

  4. Hospital Universitario Vall d’Hebron, Barcelona, Spain

    David Valcárcel & Guillermo Ortí

  5. Hospital Universitario Reina Sofía, Córdoba, Spain

    Carmen Martín- Calvo

  6. Hospital Universitario 12 de Octubre, Madrid, Spain

    Javier de la Serna

Authors
  1. Mónica Cabrero
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  2. Lucia López-Corral
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Consortia

Grupo Español de Trasplante Hematopoyético (GETH) and Grupo Español de Linfomas y Trasplante Autólogo (GELTAMO)

  • Mónica Cabrero
  • , Lucia López-Corral
  • , Isidro Jarque
  • , Fátima de la Cruz-Vicente
  • , Estefanía Pérez- López
  • , David Valcárcel
  • , Jaime Sanz
  • , Ildefonso Espigado
  • , Guillermo Ortí
  • , Carmen Martín- Calvo
  • , Javier de la Serna
  •  & Dolores Caballero

Contributions

MC authored the manuscript; DC was the principal investigator of the trial and supervised manuscript preparation overseeing all the critical aspects; all remaining authors contributed to trial design, patient recruitment and monitoring, and manuscript review. All authors approve the final version of the manuscript for submission.

Corresponding author

Correspondence to Mónica Cabrero.

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Cabrero, M., López-Corral, L., Jarque, I. et al. 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. Bone Marrow Transplant 59, 359–365 (2024). https://doi.org/10.1038/s41409-023-02171-5

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