CancerPhase 3NCT00045292
Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation
A Phase 3 study testing acyclovir, acyclovir sodium and valacyclovir in people with Cancer, run by Fred Hutchinson Cancer Center at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- acyclovir, acyclovir sodium and valacyclovir
- How many people
- Not given
- Where
- 6 sitesUnited States
- Study dates
- Apr 2002to Oct 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Baylor University Medical Center
Dallas, Texas, 75246
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
Huntsman Cancer Institute
Salt Lake City, Utah, 84132
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, 94305
About this study
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
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- acyclovir, acyclovir sodium, valacyclovir
- Keywords
- 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
- Medical subject headings
- Neoplasms, Infections, Leukemia, Myeloid, Accelerated Phase, Blast Crisis, Leukemia, Myeloid, Chronic-Phase, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acyclovirDrug
acyclovir sodiumDrug
valacyclovirDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startApr 2002
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Garrett Nichols, MD, MSC, Study chair, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00045292
- Sponsor's protocol ID
- 1603.00
- Other IDs
- FHCRC-1603.00, NCI-H02-0092, CDR0000256871
- Status last verified
- Sep 2010
- First submitted
- 6 Sep 2002
- Last updated
- 21 Sep 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00045292
- Acronym / sponsor ID
- 1603.00
- Conditions
- Cancer
- Keywords
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2002
- Study completion
- Oct 2004 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acyclovir | Drug | – |
| acyclovir sodium | Drug | – |
| valacyclovir | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Garrett Nichols, MD, MSC study chair
Fred Hutchinson Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing acyclovir, acyclovir sodium and valacyclovir in people with Cancer, run by Fred Hutchinson Cancer Center at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2010; AzTrials last refreshed its copy on 8 Nov 2026.