• Yoshinobu Kanda, Kumi Oshima, Shinichi Kako, Takahiro Fukuda, Naoyuki Uchida, Koichi Miyamura, Yukio Kondo, Shinji Nakao, Koji Nagafuji, Toshihiro Miyamoto, Mineo Kurokawa, Yasushi Okoshi, Shigeru Chiba, Yasuo Ohashi, Yoichi Takaue, and Shuichi Taniguchi.
• Division of Hematology, Saitama Medical Center, Jichi Medical University, Saitama, Japan. ycanda-tky@umin.ac.jp
• Am. J. Hematol. 2013 Apr 1; 88 (4): 294-300.

AbstractWe evaluated the efficacy of in vivo T-cell depletion with alemtuzumab in two prospective studies according to the International Conference on Harmonisation (ICH)-Good Clinical Practice (ICH-GCP) guidelines; one was for patients with aplastic anemia (AA study) and the other was for patients who were undergoing hematopoietic stem cell transplantation (HSCT) from a 2- or 3-antigen-mismatched haploidentical donor (MM study). The final dose of alemtuzumab in these studies was 0.16 mg/kg/day for 6 days. At this dose, all of the 12 and 11 patients in the AA and MM studies, respectively, achieved initial engraftment and the incidences of Grade II-IV acute graft-versus-host disease (GVHD) were 0% and 18%. While cytomegalovirus (CMV) frequently reactivated, none of the patients developed fatal CMV disease. Transplantation-related mortality within 1 year after HSCT was observed in only two and one patients, respectively. The numbers of CD4+ and CD8+ T-cells and T-cell receptor rearrangement excision circles remained low within 1 year after HSCT. These findings suggest that the use of alemtuzumab at this dose in a conditioning regimen enables safe allogeneic HSCT even from a 2- or 3-antigen-mismatched donor. However, the use of a lower dose of alemtuzumab should be explored in future studies to accelerate immune recovery after HSCT.Copyright © 2013 Wiley Periodicals, Inc.

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