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

Primary Purpose

Cytomegalovirus Infections

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Valganciclovir
Ganciclovir
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Effect of preemptive therapy with IV ganciclovir and PO valganciclovir as determined by quantitative CMV PCR.
Incidence of CMV disease and CMV related mortality following preemptive treatment with oral valganciclovir and IV ganciclovir.
Compare the incidence of recurrent CMV viremia after treatment with PO valganciclovir to that seen after treatment with IV ganciclovir.
Toxicity profile of valganciclovir
Mutations in the UL97 gene in patients who have increasing CMV viral loads after 14 days of treatment
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.

Full Information

First Posted
October 17, 2005
Last Updated
July 22, 2013
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00241345
Brief Title
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

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Terminated
Why Stopped
Due to low accrual
Study Start Date
June 2004 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infections
Keywords
post transplant, Any patient receiving an allogeneic bone marrow or peripheral blood stem cell transplant at Washington University Medical Center

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Valganciclovir
Intervention Type
Drug
Intervention Name(s)
Ganciclovir
Primary Outcome Measure Information:
Title
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.
Description
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 Outcome Measure Information:
Title
Effect of preemptive therapy with IV ganciclovir and PO valganciclovir as determined by quantitative CMV PCR.
Time Frame
6 months
Title
Incidence of CMV disease and CMV related mortality following preemptive treatment with oral valganciclovir and IV ganciclovir.
Time Frame
6 months
Title
Compare the incidence of recurrent CMV viremia after treatment with PO valganciclovir to that seen after treatment with IV ganciclovir.
Time Frame
6 months
Title
Toxicity profile of valganciclovir
Time Frame
6 months
Title
Mutations in the UL97 gene in patients who have increasing CMV viral loads after 14 days of treatment
Time Frame
14 days
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravi Vij, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

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

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