Clinical Study of Granulocyte Colony-stimulating Factor (G-CSF)-Primed, Peripheral-blood Progenitor Cells for the Prevention of Relapse Advanced Stage Leukemia
A G-CSF-primed PBPCI was planned within day 60 post-transplantation before hematologic
relapse was diagnosed in patients for which no GVHD occurred or free of GVHD after 2 weeks
off immunosuppression for patients receiving GPBPCI after day 90 post HSCT. Before
administration of GPBPCI, serious infection had to be cleared and no serious organ failure
could be present. The GPBPCI regimen was comprised of G-CSF-primed PBSCs instead of
harvested non-primed donor lymphocytes and short-term immunosuppressive agents for
prevention of GVHD after GPBPCI. Chimerism status was examined before and after prophylactic
treatment with GPBPCI.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
two years after HSCT
XiaoJun Huang, M.D.
Peking University People's Hospital，Institute of Hematology
China: Ministry of Health
PUPH IRB  (78)