Results of a phase I/II British Society of Bone Marrow Transplantation study on PCR-based pre-emptive therapy with valganciclovir or ganciclovir for active CMV infection following alemtuzumab-based reduced intensity allogeneic stem cell transplantation

Leuk Res. 2009 Feb;33(2):244-9. doi: 10.1016/j.leukres.2008.07.016. Epub 2008 Sep 20.

Abstract

This multi-centre randomized study assessed the bioavailability of ganciclovir in patients undergoing alemtuzumab-based reduced intensity conditioning (RIC) haematopoietic stem cell transplantation (HSCT) after oral administration of valganciclovir. Patients were randomized to 2 groups receiving either oral valganciclovir (900 mg twice daily) or intravenous ganciclovir (5mg/kg twice daily) for 14 days. Twenty-seven patients were recruited and 18 patients (67%) completed allocated treatment resulting in clearance of cytomegolovirus (CMV) DNA load at a median of 14 days. The bioavailability of ganciclovir from valganciclovir was 73% (95% CI: 34-112%). The average exposure in the valganciclovir group (36.9+/-14.9 microg h/ml) was higher than the ganciclovir cohort (27.9+/-7.5 microg h/ml). When compared with intravenous ganciclovir, oral valganciclovir had high bioavailability in patients undergoing alemtuzumab-based RIC HSCT.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Alemtuzumab
  • Antibodies, Monoclonal / administration & dosage*
  • Antibodies, Monoclonal, Humanized
  • Antibodies, Neoplasm / administration & dosage*
  • Cytomegalovirus Infections / drug therapy*
  • Cytomegalovirus Infections / prevention & control
  • DNA, Viral / drug effects
  • Ganciclovir / administration & dosage*
  • Ganciclovir / analogs & derivatives*
  • Ganciclovir / pharmacokinetics
  • Hematopoietic Stem Cell Transplantation / methods*
  • Humans
  • Middle Aged
  • Polymerase Chain Reaction
  • Premedication / methods*
  • Transplantation Conditioning / methods
  • Transplantation, Homologous
  • Valganciclovir
  • Viral Load

Substances

  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Antibodies, Neoplasm
  • DNA, Viral
  • Alemtuzumab
  • Valganciclovir
  • Ganciclovir