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Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing 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.
 
ClinicalTrials.gov Identifier: NCT00045292
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 21, 2010
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cancer Drug: acyclovir Drug: acyclovir sodium Drug: valacyclovir Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : April 2002
Actual Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Multiple Myeloma Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Myelodysplastic Syndromes Ovarian Cancer Ovarian Epithelial Cancer Lymphosarcoma Cutaneous T-cell Lymphoma Follicular Lymphoma Chronic Myeloid Leukemia Primary Myelofibrosis Chronic Myelomonocytic Leukemia Juvenile Myelomonocytic Leukemia Neuroblastoma B-cell Lymphoma Diffuse Large B-Cell Lymphoma Chronic Lymphocytic Leukemia Mantle Cell Lymphoma Mycosis Fungoides Cytomegalic Inclusion Disease Childhood Acute Lymphoblastic Leukemia Hodgkin Lymphoma Hairy Cell Leukemia Marginal Zone Lymphoma Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Sezary Syndrome Chronic Myeloproliferative Disorders Myelodysplastic/myeloproliferative Disease Gestational Trophoblastic Tumor Burkitt Lymphoma Wilms' Tumor Ovarian Germ Cell Tumor Chronic Neutrophilic Leukemia

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00045292


Locations
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United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States, 94305
United States, Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-3330
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84132
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)
Investigators
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Study Chair: Garrett Nichols, MD, MSC Fred Hutchinson Cancer Research Center
More Information
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ClinicalTrials.gov Identifier: NCT00045292    
Other Study ID Numbers: 1603.00
FHCRC-1603.00
NCI-H02-0092
CDR0000256871 ( Registry Identifier: PDQ )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 21, 2010
Last Verified: September 2010
Keywords provided by Fred Hutchinson Cancer Research Center:
infection
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
childhood chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
relapsing chronic myelogenous leukemia
adult acute lymphoblastic leukemia in remission
childhood acute lymphoblastic leukemia in remission
recurrent adult acute lymphoblastic leukemia
recurrent childhood acute lymphoblastic leukemia
untreated adult acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia
adult acute myeloid leukemia in remission
childhood acute myeloid leukemia in remission
recurrent adult acute myeloid leukemia
 recurrent childhood acute myeloid leukemia
secondary acute myeloid leukemia
untreated adult acute myeloid leukemia
untreated childhood acute myeloid leukemia and other myeloid malignancies
atypical chronic myeloid leukemia
chronic eosinophilic leukemia
chronic idiopathic myelofibrosis
chronic neutrophilic leukemia
chronic myelomonocytic leukemia
juvenile myelomonocytic leukemia
de novo myelodysplastic syndromes
myelodysplastic/myeloproliferative disease, unclassifiable
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
disseminated neuroblastoma
Additional relevant MeSH terms:
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Infection
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents