Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer
Intervention: acyclovir (Drug); acyclovir sodium (Drug); valacyclovir (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Fred Hutchinson Cancer Research Center Official(s) and/or principal investigator(s):
Garrett Nichols, MD, MSC, Study Chair, Affiliation: Fred Hutchinson Cancer Research Center
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.
Clinical Details
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 design: Supportive Care, Randomized, Double-Blind, Placebo Control
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.
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
City of Hope Comprehensive Cancer Center, Duarte, California 91010-3000, United States
Stanford Cancer Center at Stanford University Medical Center, Stanford, California 94305, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska 68198-3330, United States
Baylor University Medical Center, Dallas, Texas 75246, United States
Huntsman Cancer Institute, Salt Lake City, Utah 84132, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington 98109-1024, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: April 2002
Last updated: May 23, 2008
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