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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

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ClinicalTrials.gov Identifier: NCT00241345
Recruitment Status : Terminated (Due to low accrual)
First Posted : October 18, 2005
Last Update Posted : July 23, 2013
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE October 17, 2005
First Posted Date  ICMJE October 18, 2005
Last Update Posted Date July 23, 2013
Study Start Date  ICMJE June 2004
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2013)
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. [ Time Frame: 4 weeks from start of therapy ]
Clearance of CMV viremia will be defined as CMV viral load less than 5,000 copies/ml of whole blood.
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2005)
The study end point for statistical purposes will be clearance of CMV viremia at 4 weeks from the start of therapy. Clearance of CMV viremia will be defined as a CMV viral load less than 5,000 copies/ml of whole blood.
Change History Complete list of historical versions of study NCT00241345 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2005)
All patients will be followed for 6 months after randomoization.
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE Randomized Trial of Preemptive Treatment With Oral Valganciclovir Compared With IV Ganciclovir for Cytomegalovirus Infection After Bone Marrow or Peripheral Blood Stem Cell Transplant
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.
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cytomegalovirus Infections
Intervention  ICMJE
  • Drug: Valganciclovir
  • Drug: Ganciclovir
Study Arms
  • Experimental: 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.
    Intervention: Drug: Ganciclovir
  • Experimental: 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.
    Intervention: Drug: Valganciclovir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 18, 2013)
39
Original Enrollment  ICMJE
 (submitted: October 17, 2005)
120
Actual Study Completion Date December 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00241345
Other Study ID Numbers  ICMJE 04-0274
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ravi Vij, M.D. Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP