Trial of Preemptive Treatment With Oral Valganciclovir Compared With Intravenous (IV) Ganciclovir for Cytomegalovirus Infection After Bone Marrow or Peripheral Blood Stem Cell Transplant
Cytomegalovirus Infections
About this trial
This is an interventional treatment trial for Cytomegalovirus Infections focused on measuring post transplant, Any patient receiving an allogeneic bone marrow or peripheral blood stem cell transplant at Washington University Medical Center
Eligibility 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
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group A
Group B
IV ganciclovir (5mg/kg every 12 hours for 7 days followed by 5mg/kg every 24 hours for 7 days. If CMV viral load <5000 copies/ml after 14 days then 5mg/kg every 24 hours for a total of 21 total days of therapy. If CMV viral load >5000/ml but less than index viral load after 14 days then 5mg/kg every 24 hours for a total of 28 total days of therapy. If CMV viral load >= index viral load after 14 days then 5mg/kg every 12 hours for 7 days. If repeat CMV viral load is <= the previous CMV viral load then 5mg/kg every 12 hours for an additional 7 days.
PO valganciclovir (900 mg every 12 hours for 7 days followed by 900 mg every 24 hours for 7 days. If CMV viral load <5000 copies/ml after 14 days then 900 mg every day until 21 total days of therapy. If CMV viral load >5000 copies/ml after 14 days but less than the index viral load then 900 mg every day until 28 total days of therapy. If CMV viral load >= the index viral load 900 mg every 12 hours for 7 days, if CMV viral load <= to previous viral load then 900 mg every 12 hours for another 7 days.