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Valganciclovir to Prevent Cytomegalovirus Infection in Patients Following Donor Stem Cell Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00016068
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 17, 2010
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center

Brief Summary:

RATIONALE: Antivirals such as valganciclovir act against viruses and may be effective in preventing cytomegalovirus. It is not yet known if valganciclovir is effective in preventing cytomegalovirus.

PURPOSE: This randomized phase III trial is studying valganciclovir to see how well it works in preventing cytomegalovirus in patients who have undergone donor stem cell transplantation.

Condition or disease Intervention/treatment Phase
Infection Drug: ganciclovir Drug: valganciclovir Phase 3

Detailed Description:



  • Compare cytomegalovirus (CMV) disease and non-CMV invasive infection-free survival in patients undergoing allogeneic hematopoietic stem cell transplantation treated with valganciclovir vs placebo.
  • Compare the incidence of CMV disease in patients treated with these drugs.
  • Compare the incidence of other severe invasive bacterial and fungal infections and overall survival in patients treated with these drugs.


  • Compare the incidence of CMV infection or disease at baseline and at days 270 and 640 after allogeneic hematopoietic stem cell transplantation in patients treated with these drugs.
  • Compare the incidence of herpes simplex virus and varicella-zoster virus infections at baseline and day 270 in patients treated with these drugs.
  • Determine the safety of valganciclovir in these patients.
  • Compare the quality of life of patients treated with these drugs.
  • Compare CMV-specific immune reconstitution in patients treated with these drugs.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center, prior neutropenia (yes vs no), and presence of refractory graft-versus-host disease requiring secondary therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral valganciclovir daily.
  • Arm II: Patients receive oral placebo daily. Treatment begins around day 80-120 post-transplantation and continues until day 270 post-transplantation in the absence of active infection or unacceptable toxicity. Patients developing active cytomegalovirus (CMV) infection receive induction doses of ganciclovir IV or open-label oral valganciclovir for 1 week followed by open-label oral valganciclovir maintenance dosing until CMV can no longer be detected.

Quality of life is assessed at baseline and days 180 and 270 post-transplantation.

Patients are followed at days 400, 520, and 640 post-transplantation.

PROJECTED ACCRUAL: A total of 184 patients (92 per treatment arm) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Supportive Care
Official Title: A Phase III Multicenter Study Of Valganciclovir For The Prevention Of Late Cytomegalovirus Infection After Allogeneic Hematopoietic Stem Cell Transplantation
Study Start Date : January 2001
Actual Study Completion Date : September 2007

Primary Outcome Measures :
  1. Late cytomegalovirus infection by plasma PCR positivity

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Have undergone allogeneic peripheral blood stem cell, cord blood, or marrow transplantation (related or unrelated, T-cell depleted or non-T-cell depleted, CD34-selected or non-selected, or myeloablative or non-myeloablative) within the past 80-120 days
  • Positive pre-transplantation cytomegalovirus (CMV) serology of recipient and/or donor

    • Seropositive recipients with one of the following:

      • CMV infection before day 80, as determined by:

        • pp65 antigenemia
        • CMV DNA in plasma
        • Peripheral blood leukocytes (PBL) or whole blood at any level detected by polymerase chain reaction or hybrid capture
        • CMV pp67 mRNA
        • CMV viremia by blood culture
        • Surveillance bronchoalveolar lavage (culture or cytology)
      • CMV disease more than 6 weeks prior to enrollment
      • Presence of graft-versus-host disease (GVHD) at enrollment

        • Acute GVHD that requires treatment with systemic corticosteroids of doses greater than 0.5 mg/kg OR
        • Chronic clinically extensive GVHD requiring treatment with corticosteroids
      • Continuous prophylaxis with ganciclovir, foscarnet, or cidofovir between engraftment and day 80 OR
    • Seronegative recipient with seropositive donor who has CMV infection before day 80
  • No rising or uncontrolled CMV load (pp65 antigenemia levels no greater than 1/slide or no greater than 100 copies of CMV DNA per mL of plasma or per million PBL allowed)
  • No CMV disease within 6 weeks prior to randomization
  • No leukemic relapse

    • Cytogenetic or molecular relapse allowed



  • 16 and over

Performance status:

  • Not specified

Life expectancy:

  • At least 2 weeks


  • Absolute neutrophil count at least 1,000/mm^3 for at least 1 week prior to enrollment


  • Not specified


  • Creatinine no greater than 2.5 mg/mL


  • No hypersensitivity to ganciclovir or valganciclovir
  • No uncontrolled diarrhea or severe gastrointestinal disease that would preclude oral medication
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 90 days after study participation
  • HIV negative
  • Proficient in English


Biologic therapy:

  • See Disease Characteristics


  • Not specified

Endocrine therapy:

  • See Disease Characteristics


  • Not specified


  • Not specified


  • Prior ganciclovir, foscarnet, cidofovir, high-dose acyclovir, or valacyclovir as prophylaxis or preemptive therapy allowed
  • No concurrent prophylactic foscarnet, cidofovir, or ganciclovir (IV or oral)
  • No concurrent prophylactic high-dose acyclovir (more than 800 mg twice daily), valacyclovir (more than 500 mg twice daily), cidofovir (more than 0.5 mg/kg per week), or famciclovir (more than 500 mg/day) except for limited treatment courses at higher doses for varicella-zoster virus infections

    • Concurrent low-dose (≤ 0.5 mg/kg per week) cidofovir allowed for limited treatment courses

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00016068

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United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
United States, Florida
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
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Study Chair: Michael Boeckh, MD Fred Hutchinson Cancer Research Center
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00016068    
Other Study ID Numbers: 1577.00
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 17, 2010
Last Verified: May 2010
Keywords provided by Fred Hutchinson Cancer Research Center:
Additional relevant MeSH terms:
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Communicable Diseases
Cytomegalovirus Infections
Disease Attributes
Pathologic Processes
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action