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

Haematologica. 2006 Apr;91(4):550-3.

Abstract

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.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Antigens, CD34
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Bayes Theorem
  • Double-Blind Method
  • Graft Survival
  • Granulocyte Colony-Stimulating Factor / administration & dosage*
  • Hematopoietic Stem Cell Mobilization / methods*
  • Humans
  • Leukapheresis / methods
  • Lymphoma, Non-Hodgkin / therapy*
  • Middle Aged
  • Peripheral Blood Stem Cell Transplantation / methods
  • Transplantation, Autologous

Substances

  • Antigens, CD34
  • Granulocyte Colony-Stimulating Factor