Brain and Central Nervous System TumorsNCT00952185
Influenza Vaccine in Preventing Flu in Patients Who Have Undergone Stem Cell Transplant and in Healthy Volunteers
A study testing cytology specimen collection procedure, fluorescent antibody technique and assessment of therapy complications in people with Brain and Central Nervous System Tumors and Chronic Myeloproliferative Disorders, run by City of Hope Medical Center at 1 site in United States.
Trial summary
RATIONALE: The influenza vaccine may help prevent flu in patients who have undergone stem cell transplant. PURPOSE: This clinical trial is studying how well the influenza vaccine works in preventing flu in patients who have undergone stem cell transplant and in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Leukemia
- What is being tested?
- cytology specimen collection procedure, fluorescent antibody technique and assessment of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jun 2010
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Meets 1 of the following:
- Patient at City of Hope or Kaiser hospital who underwent prior autologous or allogeneic matched-related hematopoietic stem cell transplantation (HSCT) or matched-unrelated HSCT for treatment of hematological malignancies, including aplastic anemia or myelodysplastic syndromes
- Must agree to return to City of Hope for screening every 2-4 weeks during the flu season
- 100-365 days post-transplant
- Any prior therapy allowed
- Employee volunteer from the City of Hope who agrees to have a nasopharyngeal wash performed at General Clinical Research Center every 2 weeks during the flu season
- Must be eligible (per physicians instructions) and vaccinated during the 2008-2009 or 2009-2010 flu season
PATIENT CHARACTERISTICS:
- Life expectancy > 9 months
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
About this study
Official title: Clinical Correlates of Immunologic Responses to the Flu Vaccine
RATIONALE: The influenza vaccine may help prevent flu in patients who have undergone stem cell transplant.
PURPOSE: This clinical trial is studying how well the influenza vaccine works in preventing flu in patients who have undergone stem cell transplant and in healthy volunteers.
Read the detailed description
OBJECTIVES:
- To examine the incidence rate of influenza infection over two flu seasons in patients who have undergone hematopoietic stem cell transplantation at the City of Hope National Medical Center.
- To correlate influenza infection with graft-vs-host disease, age, and transplant type in these patients.
- To examine and compare the incidence rate of influenza in healthy volunteers to the incidence rate in these patients.
OUTLINE: Beginning approximately 2 weeks after vaccination or the onset of flu season, patients and healthy participants undergo nasopharyngeal washes every 14-17 days (2-10 washes) during the months of November-March of the 2008-2009 and 2009-2010 flu seasons. Samples are analyzed by direct fluorescent antibodies.
Patients and participants complete case report forms detailing flu-like symptoms experienced in the 2 weeks before sample collection.
PROJECTED ACCRUAL: A total of 150 patients and 75 healthy volunteers will be accrued for this study.
- Conditions
- Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm
- Being tested
- cytology specimen collection procedure, fluorescent antibody technique, assessment of therapy complications
- Keywords
- viral infection, aplastic anemia, accelerated phase chronic myelogenous leukemia, acute undifferentiated leukemia, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), atypical chronic myeloid leukemia, BCR-ABL negative, blastic phase chronic myelogenous leukemia, chronic myelomonocytic leukemia, chronic phase chronic myelogenous leukemia, mast cell leukemia, meningeal chronic myelogenous leukemia, progressive hairy cell leukemia, initial treatment, prolymphocytic leukemia, recurrent adult acute lymphoblastic leukemia
- Medical subject headings
- Central Nervous System Neoplasms, Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorders, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytology specimen collection procedureOther
fluorescent antibody techniqueOther
assessment of therapy complicationsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of influenza infection in patients and healthy volunteers
Secondary outcomes (2)
Correlation of influenza infection with graft-vs-host disease, age, and transplant type in patients
Vaccine protection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startNov 2008
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: Very low enrollment and follow-up, cannot meet study objectives
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by City of Hope Medical 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Aprille Seidel, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952185
- Sponsor's protocol ID
- 08121
- Other IDs
- P30CA033572, CHNMC-08121
- Status last verified
- Jun 2015
- First submitted
- 4 Aug 2009
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Correlates of Immunologic Responses to the Flu Vaccine
- ClinicalTrials.gov ID
- NCT00952185
- Acronym / sponsor ID
- 08121
- Conditions
- Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm
- Keywords
- viral infection, aplastic anemia, accelerated phase chronic myelogenous leukemia, acute undifferentiated leukemia, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Very low enrollment and follow-up, cannot meet study objectives
- Enrolment
- 9 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 6 Aug 2009 (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: The influenza vaccine may help prevent flu in patients who have undergone stem cell transplant.
PURPOSE: This clinical trial is studying how well the influenza vaccine works in preventing flu in patients who have undergone stem cell transplant and in healthy volunteers.
Detailed description
OBJECTIVES:
- To examine the incidence rate of influenza infection over two flu seasons in patients who have undergone hematopoietic stem cell transplantation at the City of Hope National Medical Center.
- To correlate influenza infection with graft-vs-host disease, age, and transplant type in these patients.
- To examine and compare the incidence rate of influenza in healthy volunteers to the incidence rate in these patients.
OUTLINE: Beginning approximately 2 weeks after vaccination or the onset of flu season, patients and healthy participants undergo nasopharyngeal washes every 14-17 days (2-10 washes) during the months of November-March of the 2008-2009 and 2009-2010 flu seasons. Samples are analyzed by direct fluorescent antibodies.
Patients and participants complete case report forms detailing flu-like symptoms experienced in the 2 weeks before sample collection.
PROJECTED ACCRUAL: A total of 150 patients and 75 healthy volunteers will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- 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 |
|---|---|---|
| cytology specimen collection procedure | Other | – |
| fluorescent antibody technique | Other | – |
| assessment of therapy complications | Procedure or surgery | – |
Primary outcome
Incidence of influenza infection in patients and healthy volunteers
2 secondary outcomes
Correlation of influenza infection with graft-vs-host disease, age, and transplant type in patients
Vaccine protection
Results and safety
The study was stopped early (reason given: Very low enrollment and follow-up, cannot meet study objectives). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
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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.
Aprille Seidel, PhD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cytology specimen collection procedure, fluorescent antibody technique and assessment of therapy complications in people with Brain and Central Nervous System Tumors and Chronic Myeloproliferative Disorders, run by City of Hope Medical Center 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: stopped early, as of the sponsor's last update on 8 Jun 2015. 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.
Are results available for this study?
The study was stopped early (reason given: Very low enrollment and follow-up, cannot meet study objectives). Results are not available in the source record.
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?
Incidence of influenza infection in patients and healthy volunteers. 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 8 Jun 2015.