[Background] Haploidentical hematopoietic stem cell transplantation (haplo-HSCT) is increasingly utilized as a curative approach for various hematologic malignancies. However, major challenges in haplo-HSCT include a high incidence of graft-versus-host disease (GVHD), frequent occurrences of engraftment failure and transplant rejection. These issues are exacerbated by the increasing age of donors (≥ 40 years). There is an urgent need for more refined treatment strategies that mitigate the negative impact of older donors (≥ 40 years) on patient outcomes. Recent studies have demonstrated that haplo-HSCT combined with umbilical cord blood (UCB) transfusion has achieved rapid engraftment, low incidence of GVHD, and a low rate of disease recurrence in the treatment of hematological malignancies. We therefore conducted a study of haplo-HSCT combined with UCB in the treatment of hematological malignancies.

[Methods] In this multicenter, single-arm trial, patients diagnosed with hematological malignancies, who were planned to undergo haplo-HSCT with donors aged 40 years or older, from 3 different tertiary medical centers in China were included. The patients were received the infusion of UCB within 24 hours following the completion of haplo-HSCT. The UCB was HLA matched (≥ 5/10 alleles) and preference was given to blood group matching. The primary endpoint was the 100-day cumulative incidences of grade II-IV aGVHD. The secondary endpoints were the day of neutrophil and platelet engraftment. Here, we report results of the interim analysis.

[Results] As of June 2024, a total of 36 patients were enrolled, with a median age of 26 years (range, 14-65 years), 23 males and 13 females. The disease diagnoses included myeloid malignancies (20/36, 55.6%) and lymphoid malignancies (16/36 44.4%). The disease status of 3 patients were no remission, 4 patients were MRD positive and 29 patients were complete remission. The median age of donors were 50 years (range, 40-59 years). The 100-day cumulative incidences of grade II-IV aGVHD were 22.2% (8/36). The median day of neutrophil and platelet engraftment was at day 12 (range, 10-24) and day 13 (range, 10-42), respectively.

[Conclusion] This study showed that haplo-HSCT combined with UCB can effectively reduce incidence of grade II-IV aGVHD and achieve rapid engraftment in patients with hematological malignancies.

Disclosures

No relevant conflicts of interest to declare.

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2024
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