Clinical trial NCT00241345: Trial of Preemptive Treatment With Oral Valganciclovir Compared With Intravenous (IV) Ganciclovir for Cytomegalovirus Infection After Bone Marrow or Peripheral Blood Stem Cell Transplant
Official title: Randomized Trial of Preemptive Treatment With Oral Valganciclovir Compared With IV Ganciclovir for Cytomegalovirus Infection After Bone Marrow or Peripheral Blood Stem Cell Transplant
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cytomegalovirus Infections
Keywords: post transplant
Any patient receiving an allogeneic bone marrow or peripheral blood stem cell transplant at Washington University Medical Center
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2005-10-18
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: * 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.

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

Primary outcomes:
measure: 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.
timeFrame: 4 weeks from start of therapy
Secondary outcomes:
measure: Effect of preemptive therapy with IV ganciclovir and PO valganciclovir as determined by quantitative CMV PCR.
timeFrame: 6 months
measure: Incidence of CMV disease and CMV related mortality following preemptive treatment with oral valganciclovir and IV ganciclovir.
timeFrame: 6 months
measure: Compare the incidence of recurrent CMV viremia after treatment with PO valganciclovir to that seen after treatment with IV ganciclovir.
timeFrame: 6 months
measure: Toxicity profile of valganciclovir
timeFrame: 6 months
measure: Mutations in the UL97 gene in patients who have increasing CMV viral loads after 14 days of treatment
timeFrame: 14 days
measure: 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.
timeFrame: 6 months
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ravi Vij, M.D.
role: PRINCIPAL_INVESTIGATOR
References: