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

NCT00241345 | Terminated Phase 3

• 1 other identifier: 04-0274
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Cytomegalovirus Infections

Keywords

post transplant; Any patient receiving an allogeneic bone marrow or peripheral blood stem cell transplant at Washington University Medical Center

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

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

  6 months

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

  6 months

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

  6 months

• Toxicity profile of valganciclovir

  6 months

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

  14 days

Study Arms (2)

Group A

EXPERIMENTAL

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.

Drug: Ganciclovir

Group B

EXPERIMENTAL

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.

Drug: Valganciclovir

Interventions

Valganciclovir DRUG

Group B

Ganciclovir DRUG

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Valganciclovir; Ganciclovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ravi Vij, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2005
• First Posted: October 18, 2005
• Study Start: June 1, 2004
• Primary Completion: November 1, 2007
• Study Completion: December 1, 2007
• Last Updated: July 23, 2013

Record last verified: 2013-07

Locations

US (1)