Clinical drug investigation · 2011
Safety of recombinant human thrombopoietin in adults after related donor haploidentical haematopoietic stem cell transplantation: a pilot study.
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Liu Dai-Hong, Huang Xiao-Jun, Liu Kai-Yan, Xu Lan-Ping, Chen Yu-Hong, Wang Yu, Han Wei, Chen Huan
Аннотация
BACKGROUND AND OBJECTIVE: Delayed recovery of platelets can be found in recipients of related donor haploidentical haematopoietic stem cell transplantation (HSCT). The objective of this study was to evaluate the safety of recombinant human thrombopoietin (rhTPO) administration prior to engraftment in patients who received related donor haploidentical HSCT.
METHODS: Nineteen patients with haematological malignancies received rhTPO prior to platelet engraftment after related donor haploidentical HSCT. Safety and tolerability levels together with the influence of rhTPO on the outcome of transplantation were evaluated.
RESULTS: Slight elevations in ALT and/or AST were observed in five patients; in two other patients, bilirubin levels increased slightly. No significant changes in routine examination findings and no allergic reactions were observed during the study period. Eighteen patients achieved platelet engraftment at a median of 16 (range 11-34) days. The cumulative ± SD incidence of acute graft-versus-host disease (GVHD) grade 1-4 at +100 days was 68.4 ± 10.7%, and that of chronic GVHD at 3 years was 24.7 ± 10.7%. Nine (47.4%) patients survived free of relapse, with a median follow-up of 1631 (1550-1734) days after transplantation.
CONCLUSION: Early administration of rhTPO prior to engraftment was safe and well tolerated in patients receiving related donor haploidentical HSCT.
METHODS: Nineteen patients with haematological malignancies received rhTPO prior to platelet engraftment after related donor haploidentical HSCT. Safety and tolerability levels together with the influence of rhTPO on the outcome of transplantation were evaluated.
RESULTS: Slight elevations in ALT and/or AST were observed in five patients; in two other patients, bilirubin levels increased slightly. No significant changes in routine examination findings and no allergic reactions were observed during the study period. Eighteen patients achieved platelet engraftment at a median of 16 (range 11-34) days. The cumulative ± SD incidence of acute graft-versus-host disease (GVHD) grade 1-4 at +100 days was 68.4 ± 10.7%, and that of chronic GVHD at 3 years was 24.7 ± 10.7%. Nine (47.4%) patients survived free of relapse, with a median follow-up of 1631 (1550-1734) days after transplantation.
CONCLUSION: Early administration of rhTPO prior to engraftment was safe and well tolerated in patients receiving related donor haploidentical HSCT.