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

NCT ID: NCT00241345

Last Updated: 2013-07-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2007-12-31

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.

Conditions

Cytomegalovirus Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

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.

Group Type: EXPERIMENTAL

Ganciclovir

Intervention Type: DRUG

Group B

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.

Group Type: EXPERIMENTAL

Valganciclovir

Intervention Type: DRUG

Interventions

Valganciclovir

Intervention Type: DRUG

Ganciclovir

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ravi Vij, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Related Links

http://www.siteman.wustl.edu

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

Other Identifiers

04-0274

Identifier Type: -

Identifier Source: org_study_id