Introduction

Allogeneic stem cell transplantation (SCT) for elderly patients presents difficulties due to graft-versus-host disease (GVHD) and elevated non-relapse mortality (NRM). Advancing age correlates with a higher comorbidity index, diminished performance status, and an inherently increased risk of disease, all of which negatively affect survival rates. We conducted a prospective pilot study that the addition of humanized anti-CD25 monoclonal antibody as GVHD prophylaxis for older patients with hematologic malignancies undergoing haplo-identical donor transplantation.

Method

We prospectively reported and analyzed the data of 9 patients (>50 years old) with hematologic malignancies who received haplo-HSCT from Augst 2023 to April 2024. The enrolled patients were administrated with a combination of cyclosporine (CsA) or tacrolimus, mycophenolate mofetil (MMF), anti-human thymocyte immunoglobulin (ATG), MTX (15mg, +1d, 10mg, +3d, +6d,+11d), and humanized anti-CD25 monoclonal antibody (Xenopax, 1mg/kg, +1d, +4d) . This study is registered with the clinicaltrial.gov (NCT05923814).

Result

All patients achieved neutrophil and platelet engraftment (neutrophil: 14 days (11-20); platelet: 19 days (11-33). Two patient developed intestine involved grade II and III aGVHD, respectively. Of note, the two aGVHD cases resolved following treatment with a median time of 21 (14 - 28) days and no recipients died of aGVHD or associated complications. No cGVHD cases were diagnosed. No severe bacterial/fungus occurred. At a median follow-up of 271 days (range, 73 - 359), only one patient died of RSV pneumonia.

Conclusions

The humanized anti-CD25 monoclonal antibody is a promising GVHD prophylaxis for older patients receiving haplo-HSCT.

Disclosures

No relevant conflicts of interest to declare.

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2024
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