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

Phase 3TerminatedNCT00241345

Washington University School of Medicine39 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cytomegalovirus Infections

Interventions

ValganciclovirDRUG

GanciclovirDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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.

Clearance of CMV viremia will be defined as CMV viral load less than 5,000 copies/ml of whole blood.

Time frame: 4 weeks from start of therapy

Secondary Outcomes

Effect of preemptive therapy with IV ganciclovir and PO valganciclovir as determined by quantitative CMV PCR.

Time frame: 6 months

Incidence of CMV disease and CMV related mortality following preemptive treatment with oral valganciclovir and IV ganciclovir.

Time frame: 6 months

Compare the incidence of recurrent CMV viremia after treatment with PO valganciclovir to that seen after treatment with IV ganciclovir.

Time frame: 6 months

Toxicity profile of valganciclovir

Time frame: 6 months

Mutations in the UL97 gene in patients who have increasing CMV viral loads after 14 days of treatment

Time frame: 14 days

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.

Time frame: 6 months

Data from ClinicalTrials.gov

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