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 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00241345
• Other study ID #: 04-0274
• Status: Terminated
• Phase: Phase 3
• First received: October 17, 2005
• Last updated: July 22, 2013
• Start date: June 2004
• Est. completion date: December 2007

Study information

• Verified date: July 2013
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: December 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytomegalovirus Infections
• Infection

Intervention

Drug:
• Valganciclovir

• Ganciclovir

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks from start of therapy	Yes
Secondary	Effect of preemptive therapy with IV ganciclovir and PO valganciclovir as determined by quantitative CMV PCR.		6 months	No
Secondary	Incidence of CMV disease and CMV related mortality following preemptive treatment with oral valganciclovir and IV ganciclovir.		6 months	No
Secondary	Compare the incidence of recurrent CMV viremia after treatment with PO valganciclovir to that seen after treatment with IV ganciclovir.		6 months	No
Secondary	Toxicity profile of valganciclovir		6 months	Yes
Secondary	Mutations in the UL97 gene in patients who have increasing CMV viral loads after 14 days of treatment		14 days	No
Secondary	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.		6 months	No

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine