Phase II Study of Intravenous Ganciclovir Followed by Oral Ganciclovir in the Treatment of Reactivation of CMV Following Bone Marrow Transplant
- To determine the feasibility of using oral ganciclovir (GCV) following induction with
intravenous GCV in the setting of cytomegalovirus (CMV) reactivation after bone marrow
- To evaluate the clearance of CMV as measured by quantitative plasma polymerase chain
reaction (PCR) using this schema of treatment.
- To establish the feasibility of measuring steady state GCV blood levels in patients on
- To correlate GCV pharmacokinetic data with clinical outcome of these patients.
- To explore the feasibility of a CMV management guideline that incorporates PCR results
in clinical decision making.
OUTLINE: Blood cultures for cytomegalovirus (CMV) are obtained periodically after the
planned bone marrow transplantation (BMT). Patients showing reactivation of CMV receive
induction ganciclovir (GCV) IV twice a day on days 1-7. Patients then receive maintenance
oral GCV three times a day for 5 weeks in the absence of disease progression or unacceptable
Patients undergo blood collection periodically during study for pharmacokinetic studies.
Primary Purpose: Supportive Care
Patient compliance with an oral ganciclovir (GCV) regimen following induction with IV GCV as measured by a self-recorded patient diary and number of adverse events
Ricardo T. Spielberger, MD
Beckman Research Institute
United States: Federal Government