Clinical Trial: Trial of Preemptive Treatment With Oral Valganciclovir Compared With Intravenous (IV) Ganciclovir for Cytomegalovirus Infection After Bone Marrow or Peripheral Blood Stem Cell Transplant

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Randomized Trial of Preemptive Treatment With Oral Valganciclovir Compared With IV Ganciclovir for Cytomegalovirus Infection After Bone Marrow or Peripheral Blood Stem Cel

Brief Summary: The purpose of this trial is to determine if preemptive therapy with oral valganciclovir is as effective as intravenous ganciclovir in clearing cytomegalovirus (CMV) viremia as determined by quantitative CMV polymerase chain reaction (PCR) assay in patients who have undergone bone marrow or peripheral blood stem cell transplant.

Detailed Summary:

  • To study the effect of preemptive therapy with IV ganciclovir and PO valganciclovir as determined by quantitative CMV PCR.
  • To determine the incidence of CMV disease and CMV related mortality following preemptive treatment with oral valganciclovir and IV ganciclovir.
  • To compare the incidence of recurrent CMV viremia after treatment with PO valganciclovir to that seen after treatment with IV ganciclovir.
  • To determine the toxicity profile of valganciclovir.
  • To screen for mutations in the UL97 gene in patients who have increasing CMV viral loads after 14 days of treatment.
  • To determine if patients treated with PO valganciclovir have ganciclovir drug levels which are equivalent to those seen in historical control subjects treated with PO valganciclovir.

Sponsor: Washington University School of Medicine

Current Primary Outcome: If preemptive therapy with oral valganciclovir is as effective as intravenous ganciclovir in clearing CMV viremia as determined by quantitative CMV PCR assay in patients who have undergone allogeneic bone marrow or peripheral stem cell transplant. [ Time Frame: 4 weeks from start of therapy ]

Clearance of CMV viremia will be defined as CMV viral load less than 5,000 copies/ml of whole blood.


Original Primary Outcome: The study end point for statistical purposes will be clearance of CMV viremia at 4 weeks from the start of therapy. Clearance of CMV viremia will be defined as a CMV viral load less than 5,000 copies/ml of whole blood.

Current Secondary Outcome:

  • Effect of preemptive therapy with IV ganciclovir and PO valganciclovir as determined by quantitative CMV PCR. [ Time Frame: 6 months ]
  • Incidence of CMV disease and CMV related mortality following preemptive treatment with oral valganciclovir and IV ganciclovir. [ Time Frame: 6 months ]
  • Compare the incidence of recurrent CMV viremia after treatment with PO valganciclovir to that seen after treatment with IV ganciclovir. [ Time Frame: 6 months ]
  • Toxicity profile of valganciclovir [ Time Frame: 6 months ]
  • Mutations in the UL97 gene in patients who have increasing CMV viral loads after 14 days of treatment [ Time Frame: 14 days ]
  • Determine if patients treated with PO valganciclovir have ganciclovir drug levels which are equivalent to those seen in historical control subjects treated with PO valganciclovir. [ Time Frame: 6 months ]


Original Secondary Outcome: All patients will be followed for 6 months after randomoization.

Information By: Washington University School of Medicine

Dates:
Date Received: October 17, 2005
Date Started: June 2004
Date Completion:
Last Updated: July 22, 2013
Last Verified: July 2013