Valganciclovir in Prevention of Cytomegalovirus (CMV) Reactivation Following Allogeneic-Stem Cell Transplantation (SCT)
Condition: Bone Marrow Transplantation; Cytomegalovirus
Study type: Interventional
Phase: Phase 3

Summary: 
      The rationale for this protocol is based on the need to assess if the current post stem cell
      transplantation CMV prophylaxis strategies (e.g. high-dose acyclovir plus pre-emptive
      treatment) can be improved by the use of valganciclovir. CMV is the most common viral
      infection following stem cell transplantation, causing significant morbidity and mortality.
      Furthermore, CMV has been shown to be associated with a number of indirect effects in SCT
      recipients including allograft dysfunction, acute and chronic graft versus host disease
      (GVHD). Valganciclovir is shown to be more active than oral ganciclovir, and as good as
      intravenous (i.v.) ganciclovir in treating newly diagnosed CMV retinitis. The use of
      valganciclovir for CMV prophylaxis post stem cell transplantation was never tested in
      controlled study. The investigators therefore suggest a prospective, randomized study to
      evaluate the efficacy and safety of valganciclovir compared with acyclovir for prevention of
      CMV disease in allogeneic stem cell transplantation recipients.
    

Detailed description: 
      Cytomegalovirus (CMV), the most common viral infection following stem cell transplantation
      (SCT), causes significant morbidity and mortality. It can result in CMV pneumonitis,
      hepatitis, encephalitis and gastrointestinal disease, as well as fever and neutropenia.
      Furthermore, CMV has been shown to be associated with a number of indirect effects in SCT
      recipients including reduced long-term patient survival, increased risks of opportunistic
      infections, allograft dysfunction, acute and chronic graft vs. host disease (GVHD). SCT
      patients at highest risk are seronegative donors, matched unrelated donors, SCT with T-cell
      depletion, patients after cord blood SCT, and patients with GVHD.

      Valganciclovir, a valine ester pro-drug of ganciclovir, was developed to overcome the
      limitations of oral and i.v. ganciclovir, with a single once-daily 900 mg oral dose providing
      comparable plasma ganciclovir exposures to those achieved with 5 mg/kg i.v. ganciclovir. Its
      bioavailability is up to 10-fold higher than that of oral ganciclovir (same as above). There
      is already extensive clinical experience with valganciclovir in AIDS patients, where it has
      proved as effective as i.v. ganciclovir in treating newly diagnosed CMV retinitis, and in
      patients after solid organ transplant but no comparative data exists in patients after SCT.

      We therefore planned a prospective, randomized study to evaluate the efficacy and safety of
      valganciclovir compared with acyclovir for prevention of CMV disease in SCT recipients.
    

Intervention name(s): Valganciclovir; Acyclovir
Intervention type(s): Drug; Drug
Intervention description(s): Valganciclovir; Acyclovir
Intervention MeSH terms: Acyclovir; Valganciclovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: BMT; CMV; GVHD