Prospective Phase 2 Study of Umbilical Cord Blood Transplantation in Adult Acute Leukemia and Myelodysplastic Syndrome |
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| Affiliation: | 1. Department of Hematology and Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan;2. Department of Hematology and Oncology, Anjo Kosei Hospital, Anjo, Japan;3. Department of Hematology, Japanese Red Cross Nagoya First Hospital, Nagoya, Japan;4. Department of Hematology and Oncology, JA Aichi Konan Kosei Hospital, Konan, Japan;5. Department of Hematology and Rheumatology, Tohoku University Hospital, Sendai, Japan;6. Department of Hematology and Oncology, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan;7. Department of Hematology and Oncology, Okayama University Graduate School of Medicine, Okayama, Japan;8. Department of Hematology, National Hospital Organization, Sendai Medical Center, Sendai, Japan;9. Department of Hematology, Meitetsu Hospital, Nagoya, Japan;10. Department of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan;11. Department of Hematology, Gifu University Hospital, Gifu, Japan;12. Department of Hematology, Mie University Hospital, Tsu, Japan;13. Department of Hematology and Oncology, Shimane Prefectural Central Hospital, Izumo, Japan;14. Department of Hematology, Hakodate Municipal Hospital, Hakodate, Japan;15. Department of Hematology, National Center for Global Health and Medicine, Tokyo, Japan;16. Department of Hematology, Shizuoka General Hospital, Shizuoka, Japan;17. Department of Hematology, Sasebo City General Hospital, Sasebo, Japan;18. Department of Hematology, Sapporo Hokuyu Hospital, Sapporo, Japan;19. Japanese Data Center for Hematopoietic Cell Transplantation, Nagoya, Japan;20. Department of Oncology and Hematology, Shimane University Hospital, Izumo, Japan;21. Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan |
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| Abstract: | Almost comparable transplantation outcomes have been reported with HLA-matched unrelated donor transplantation (UDT) and cord blood transplantation (CBT). We conducted a prospective phase 2 study to assess the efficacy and safety of single-unit myeloablative CBT in adult leukemia and myelodysplastic syndrome. Because the day 180 survival of UDT was approximately 80%, we determined the alternative hypothesis of expected day 180 survival with a successful engraftment rate of 80% and set the null hypothesis of threshold rate at 65%. Sixty-two patients (median age, 37 years) were registered, including 28 with acute myelogenous leukemia, 25 with acute lymphoblastic leukemia, and 9 with myelodysplastic syndrome. Of 61 eligible patients, 52 were successfully engrafted and survived at day 180 (85%; 95% confidence interval, 74% to 93%). Single-unit CBT was judged to be effective because the null hypothesis was rejected (P < .001). Furthermore, neutrophil engraftment was observed in 57 patients (92%); the incidences of grade II-IV acute and chronic graft-versus-host disease were 30% and 32%, respectively; and the cumulative incidences of nonrelapse mortality and relapse at 2 years were 18% and 13%, respectively. The present study showed favorable survival outcomes with single-unit CBT. Therefore, this method may be considered if a well-HLA-matched UDT cannot be obtained. |
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