Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation

September 17, 2010 updated by: Fred Hutchinson Cancer Center

A Phase III Multicenter Study of Cytomegalovirus Prophylaxis With Valacyclovir for the Prevention of Serious Fungal and Bacterial Infections Among Cytomegalovirus Seronegative Recipients of Cytomegalovirus Seropositive Sx Stem Cell Transplants

RATIONALE: Antivirals such as valacyclovir act against viruses and may be effective in preventing cytomegalovirus. It is not yet known if valacyclovir is effective in preventing cytomegalovirus in patients undergoing stem cell transplantation.

PURPOSE: Randomized phase III trial to determine the effectiveness of valacyclovir in preventing cytomegalovirus in patients who are undergoing donor stem cell transplantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the occurrence of serious invasive fungal or bacterial infections during the first 270 days after transplantation in cytomegalovirus (CMV)-negative patients receiving a CMV-positive allogeneic stem cell transplantation and valacyclovir or placebo.
  • Compare the occurrence of primary CMV infection within the first 100 days after transplantation in patients treated with these regimens.
  • Compare the survival of these patients at 100 days and 270 days post-transplantation.
  • Compare the occurrence of CMV disease at day 100 and day 270 post-transplantation in patients treated with these regimens.
  • Compare the safety of these regimens in these patients.
  • Correlate the presence of CMV in stem cell product with post-transplantation CMV infection in these patients.
  • Determine if subclinical CMV infection results in a virus-specific immune response (humoral and cellular) in these patients.
  • Compare the quality of life of patients treated with these regimens.
  • Compare resource utilization (e.g., rates of hospitalization, number of days alive out of the hospital, days in the intensive care unit, days on mechanical ventilation, use of antimicrobials and filgrastim [G-CSF], and number of invasive procedures) in patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and type of transplantation (matched related vs mismatched/unrelated). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral valacyclovir 4 times daily beginning with transplantation conditioning (usually day -5) and continuing until day 100 after transplantation. Patients receive high-dose acyclovir, instead of valacyclovir, IV every 8 hours beginning on day -1 and continuing until oral medications are tolerated. Allogeneic stem cells are infused on day 0.
  • Arm II: Patients receive oral or IV placebo on the same schedule as in arm I. Quality of life is assessed at baseline and on days 50 and 100.

Patients are followed every 2 weeks for 6 months.

PROJECTED ACCRUAL: A total of 115-230 patients (58-115 per treatment arm) will be accrued for this study within 2 years.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • Stanford, California, United States, 94305
        • Stanford Cancer Center at Stanford University Medical Center
    • Nebraska
      • Omaha, Nebraska, United States, 68198-3330
        • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Huntsman Cancer Institute
    • Washington
      • Seattle, Washington, United States, 98109-1024
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Disease requiring one of the following types of stem cell transplantation:

    • First myeloablative allogeneic peripheral blood stem cell
    • Unrelated cord blood

    • Bone marrow

      • Related or unrelated donor
      • T-cell depleted or non-T-cell depleted
      • CD34 selected or non-selected
  • Patient must be cytomegalovirus (CMV)-seronegative and donor must be CMV-seropositive

  • No transplantation with nonmyeloablative regimens, including any of the following:

    • Fludarabine and total body irradiation (TBI) (2 Gy or less)
    • TBI alone (2 Gy)
    • Fludarabine, cytarabine, and idarubicin
    • Fludarabine and melphalan (140 mg/m^2 or less)
  • No definite or probable pre-transplantation diagnosis of invasive mold infection (aspergillosis, fusariosis, or zygomycosis), including pulmonary or hepatic nodules consistent with invasive mold infection for which patients are receiving targeted prophylaxis with amphotericin or other mold-active products
  • No pre-transplantation-CMV disease (gastrointestinal or pneumonia)

PATIENT CHARACTERISTICS:

Age

  • 12 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • HIV negative
  • No hypersensitivity to acyclovir or valacyclovir
  • Not pregnant
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics

Surgery

  • Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Garrett Nichols, MD, MSC, Fred Hutchinson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

September 6, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

September 21, 2010

Last Update Submitted That Met QC Criteria

September 17, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1603.00
  • FHCRC-1603.00
  • NCI-H02-0092
  • CDR0000256871 (Registry Identifier: PDQ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer

Clinical Trials on valacyclovir

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe