Bone Marrow Stem Cell TransplantPhase 3NCT00275665
The Study is Being Done to See if Taking the Drug Valganciclovir Can Prevent CMV Infection.
A Phase 3 study testing Valganciclovir in people with Bone Marrow Stem Cell Transplant, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done in stem cell transplant recipients to see if taking the drug valganciclovir can prevent or reduce serious cytomegalovirus (CMV) infections that can occur 100 days or later after transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Marrow Stem Cell Transplant
- What is being tested?
- Valganciclovir
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Jul 2007
- 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 18 years and older
- All sexes
- Adult, Older adult
Participants who are undergoing allogeneic peripheral blood stem cell, cord blood, or marrow transplantation that are 18 years of age or older, may be eligible to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Multicenter Study of Valganciclovir for the Prevention of Late Cytomegalovirus Infection After Allogenic Hematopoietic Stem Cell Transplantation.
This study is being done in stem cell transplant recipients to see if taking the drug valganciclovir can prevent or reduce serious cytomegalovirus (CMV) infections that can occur 100 days or later after transplant.
Read the detailed description
This study is a phase III, randomized, double-blind, palacebo-controlled, multicenter study of the drug valganciclovir. This study is to see if taking prophylactic doses of valganciclovir starting 100 days after stem cell transplantation can prevent late CMV from occurring.
Participants will be randomized (like a flip of a coin) into one of two groups. Neither the participant nor the doctor will know which group the participant is in. One group will receive the drug valganciclovir. The other group will receive a pill that looks like valganciclovir, but does not contain any active medicine (a placebo).
Participants enrolled in the study will take the drug by mouth daily starting at day 100 post stem cell transplant. Participants will also have blood samples taken along with their routine blood weekly, until day 270. Participants will also be required to return to their routine clinic visits.
Participants' acquiring an active CMV bloodstream infection at the time of the study will receive ganciclovir by the vein twice a day or a high dose of valganciclovir. Participants will be instructed to stop taking the study drug during the treatment time. After active CMV infection can no longer be detected, the treatment will be stopped. Patients will start taking the study drug and will be monitored for a CMV bloodstream infection until 270 days after transplant. Participants developing symptoms that look like CMV disease (pneumonia, infection of the intestines, eye infection) while on the study drug, will have an examination and lab tests to diagnose the organism. Participants that are hospitalized for CMV disease or for any other reason are asked to notify study personnel.
Participants will need to record study medicine taken in a daily study drug diary. Questionnaires will be filled out by the participant throughout the study, they will also be called monthly to see how they are doing and feeling overall.
After 270 days, participants will complete the study drug phrase. They will receive follow up phone calls on days 400, 520, and 640 days after transplant to see how they are doing.
- Conditions
- Bone Marrow Stem Cell Transplant
- Being tested
- Valganciclovir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValganciclovirDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
CMV disease
Invasive bacterial and fungal infections
Secondary outcomes (5)
The occurrence of CMV infection or the occurrence of CMV disease (whichever occurs first) between enrollment and day 270 after transplantation.
Occurrence of CMV disease between randomization and day 270
The occurrence of other documented clinically significant human herpesvirus infections after randomization and day 270.
Survival to include a comparison of treatments at day 270 and day 640
Safety-comparison of adverse events and serious adverse events that occur on the two arms during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2006 (estimated)
- Study startNov 2001
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow Stem Cell TransplantStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG, Fred Hutchinson Cancer Center, City of Hope National Medical Center, University of Florida, University of Michigan
- Investigators
- Mark R. Litzow, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00275665
- Sponsor's protocol ID
- 2124-01
- Status last verified
- Dec 2011
- First submitted
- 10 Jan 2006
- Last updated
- 19 Dec 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Multicenter Study of Valganciclovir for the Prevention of Late Cytomegalovirus Infection After Allogenic Hematopoietic Stem Cell Transplantation.
- ClinicalTrials.gov ID
- NCT00275665
- Acronym / sponsor ID
- 2124-01
- Conditions
- Bone Marrow Stem Cell Transplant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Roche Pharma AG, Fred Hutchinson Cancer Center, City of Hope National Medical Center, University of Florida, University of Michigan
- Study start
- Nov 2001
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 12 Jan 2006 (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.
This study is being done in stem cell transplant recipients to see if taking the drug valganciclovir can prevent or reduce serious cytomegalovirus (CMV) infections that can occur 100 days or later after transplant.
Detailed description
This study is a phase III, randomized, double-blind, palacebo-controlled, multicenter study of the drug valganciclovir. This study is to see if taking prophylactic doses of valganciclovir starting 100 days after stem cell transplantation can prevent late CMV from occurring.
Participants will be randomized (like a flip of a coin) into one of two groups. Neither the participant nor the doctor will know which group the participant is in. One group will receive the drug valganciclovir. The other group will receive a pill that looks like valganciclovir, but does not contain any active medicine (a placebo).
Participants enrolled in the study will take the drug by mouth daily starting at day 100 post stem cell transplant. Participants will also have blood samples taken along with their routine blood weekly, until day 270. Participants will also be required to return to their routine clinic visits.
Participants' acquiring an active CMV bloodstream infection at the time of the study will receive ganciclovir by the vein twice a day or a high dose of valganciclovir. Participants will be instructed to stop taking the study drug during the treatment time. After active CMV infection can no longer be detected, the treatment will be stopped. Patients will start taking the study drug and will be monitored for a CMV bloodstream infection until 270 days after transplant. Participants developing symptoms that look like CMV disease (pneumonia, infection of the intestines, eye infection) while on the study drug, will have an examination and lab tests to diagnose the organism. Participants that are hospitalized for CMV disease or for any other reason are asked to notify study personnel.
Participants will need to record study medicine taken in a daily study drug diary. Questionnaires will be filled out by the participant throughout the study, they will also be called monthly to see how they are doing and feeling overall.
After 270 days, participants will complete the study drug phrase. They will receive follow up phone calls on days 400, 520, and 640 days after transplant to see how they are doing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- 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 |
|---|---|---|
| Valganciclovir | Drug | – |
Primary outcome
CMV disease
Invasive bacterial and fungal infections
5 secondary outcomes
The occurrence of CMV infection or the occurrence of CMV disease (whichever occurs first) between enrollment and day 270 after transplantation.
Occurrence of CMV disease between randomization and day 270
The occurrence of other documented clinically significant human herpesvirus infections after randomization and day 270.
Survival to include a comparison of treatments at day 270 and day 640
Safety-comparison of adverse events and serious adverse events that occur on the two arms during the study
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 19 Dec 2011.
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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.
Mark R. Litzow, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Valganciclovir in people with Bone Marrow Stem Cell Transplant, run by Mayo Clinic at 1 site 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 19 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does the primary outcome measure?
CMV disease. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 19 Dec 2011.