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

• Status: Terminated
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Ganciclovir; Ganciclovir triphosphate; Valganciclovir

Criteria

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