| Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation
Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase III | Supportive care | Completed | 12 and over | CDR0000256871
FHCRC-1603.00, NCI-H02-0092, NCT00045292 |
Trial Description
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. Further Study Information 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 Criteria DISEASE CHARACTERISTICS: - Disease requiring one of the following types of stem cell transplantation:
- First myeloablative allogeneic peripheral blood stem cell
- 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)
- 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 Performance status Life expectancy Hematopoietic Hepatic Renal Other - No hypersensitivity to acyclovir or valacyclovir
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics
Chemotherapy - See Disease Characteristics
Endocrine therapy Radiotherapy - See Disease Characteristics
Surgery
Trial Contact Information
Trial Lead Organizations/Sponsors Fred Hutchinson Cancer Research Center National Cancer Institute
| Garrett Nichols |  | Study Chair |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00045292
Information obtained from ClinicalTrials.gov on October 06, 2009 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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