Publication Date:
2005-11-16
Description:
Background. Recombinant methionyl granulocyte colony-stimulating factor (methuG-CSF; Filgrastim) is commonly used to reduce the duration of neutropenia that follows allo BMT performed after high-dose chemo-/radiotherapy (HDT) in pts with HM. Recently, a retrospective chart review suggested that leukemic pts treated with G-CSF after allo BMT had faster neutrophil recovery, but slower platelet engraftment, increased risk of graft vs host disease (GvHD), and reduced survival relative to pts who did not receive G-CSF (Ringdén et al, 2004). The present double-blind, randomized, placebo-controlled, multicenter phase 3 study was designed to evaluate the effects of Filgrastim treatment on neutrophil recovery. Pts were to be followed for 2 years. Methods. Eligible pts were aged 12–55 and scheduled for allo BMT from a sibling donor preceded by high-dose chemotherapy +/− total body irradiation for treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL), high-risk non-Hodgkin’s lymphoma (NHL), acute myeloid leukemia (AML), or chronic myeloid leukemia (CML). Pts were randomized to receive either Filgrastim (5μg/kg/day) or placebo from transplant until recovery of an absolute neutrophil count (ANC) of ≥0.5x109/L or for a maximum of 42 days. Randomization was stratified by age (
Print ISSN:
0006-4971
Electronic ISSN:
1528-0020
Topics:
Biology
,
Medicine
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