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.
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.
Service d'Hématologie Adultes, Centre d'Investigation Clinique Hôpital Necker, Direction de la Recherche Clinique, AP-HP, Paris, France. francois.lefrere@nck.aphp.fr
François
F
Lefrère
Sarah
S
Zohar
Jean-Louis
JL
Bresson
Sylvie
S
Chevret
Agnès
A
Mogenet
Françoise
F
Audat
Isabelle
I
Durand-Zaleski
David
D
Ghez
Liliane
L
Dal Cortivo
Patrick
P
Piesvaux
Marina
M
Cavazzana-Calvo
Bruno
B
Varet
D000328:Adult; D018952:Antigens, CD34; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001499:Bayes Theorem; D004311:Double-Blind Method; D006085:Graft Survival; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D019650:Hematopoietic Stem Cell Mobilization / Q000379:methods*; D006801:Humans; D007937:Leukapheresis / Q000379:methods; D008228:Lymphoma, Non-Hodgkin / Q000628:therapy*; D008875:Middle Aged; D036102:Peripheral Blood Stem Cell Transplantation / Q000379:methods; D014182:Transplantation, Autologous
D018952:Antigens, CD34; D016179:Granulocyte Colony-Stimulating Factor