Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation
NCT ID: NCT00045292
Last Updated: 2010-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
2002-04-30
2004-10-31
Brief Summary
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PURPOSE: Randomized phase III trial to determine the effectiveness of valacyclovir in preventing cytomegalovirus in patients who are undergoing donor stem cell transplantation.
Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
DOUBLE
Interventions
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acyclovir
acyclovir sodium
valacyclovir
Eligibility Criteria
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Inclusion Criteria
* 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
12 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Principal Investigators
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Garrett Nichols, MD, MSC
Role: STUDY_CHAIR
Fred Hutchinson Cancer Center
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States
Baylor University Medical Center
Dallas, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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Other Identifiers
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FHCRC-1603.00
Identifier Type: -
Identifier Source: secondary_id
NCI-H02-0092
Identifier Type: -
Identifier Source: secondary_id
CDR0000256871
Identifier Type: REGISTRY
Identifier Source: secondary_id
1603.00
Identifier Type: -
Identifier Source: org_study_id