Haematologica, Vol 91, Issue 4, 550-553
Copyright © 2006 by Ferrata Storti Foundation
A double-blind low dose-finding phase II study of granulocyte colony-stimulating factor combined with chemotherapy for stem cell mobilization in patients with non-Hodgkin's lymphoma
F Lefrere,
S Zohar,
JL Bresson,
S Chevret,
A Mogenet,
F Audat,
I Durand-Zaleski,
D Ghez,
L Dal Cortivo,
P Piesvaux,
M Cavazzana-Calvo,
and
B Varet
Service d'Hematologie Adultes, Centre d'Investigation Clinique Hopital Necker, Direction de la Recherche Clinique, AP-HP, Paris, France. francois.lefrere@nck.aphp.fr
The aim of the study was to define the minimal effective dose (MED) of granulocyte colony-stimulating factor (G-CSF) among five daily doses following chemotherapy for peripheral blood stem cell (PBSC) collection. Twenty-five patients were included in this double-blind dose-finding phase II study conducted according to a two-stage Bayesian design. The estimated probabilities of success for PBSC collection for the G-CSF doses of 50, 75, 100, 125 and 150 microg/m2/day were 84%, 87.7%, 91%, 93.9 and 96.4%, respectively. Low G-CSF doses may be used with a similar probability of success as conventional doses and could allow significant savings.
