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

Randomized Trial of Preemptive Treatment With Oral Valganciclovir Compared With IV Ganciclovir for Cytomegalovirus Infection After Bone Marrow or Peripheral Blood Stem Cell Transplant

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.

• 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.

Inclusion Criteria:

• Patients receiving allogeneic peripheral blood stem cell transplant from either a related or unrelated donor at Washington University Medical Center.

• An initial episode of CMV viremia.

• At the time of randomization:

  • ANC greater than or equal to 1000
  • Age greater than or equal to 18
  • Adequate renal function with creatinine clearance greater than 10 ml/min
  • Total bilirubin less than or equal to 3.0

Exclusion Criteria:

• Current GI graft versus host disease grade III-IV
• Development of CMV disease prior to or at the time of the first detection of CMV viremia by PCR
• Uncontrolled emesis or diarrhea (greater than or equal to 4 episodes per day) for 2 consecutive days
• Pregnant or nursing female patient
• Known hypersensitivity to ganciclovir