Clinical Correlates of Immunologic Responses to the Flu Vaccine
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Nonmalignant Neoplasm, Virus Diseases
Both
Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Nonmalignant Neoplasm, Virus Diseases
Trial Information
Clinical Correlates of Immunologic Responses to the Flu Vaccine
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Incidence of influenza infection in patients and healthy volunteers
Safety Issue:
No
Principal Investigator
Aprille Seidel, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Beckman Research Institute
Authority:
United States: Institutional Review Board
Study ID:
08121
NCT ID:
NCT00952185
Start Date:
November 2008
Completion Date:
June 2010
Related Keywords:
- Brain and Central Nervous System Tumors
- Chronic Myeloproliferative Disorders
- Leukemia
- Lymphoma
- Lymphoproliferative Disorder
- Multiple Myeloma and Plasma Cell Neoplasm
- Myelodysplastic Syndromes
- Myelodysplastic-Myeloproliferative Diseases
- Nonmalignant Neoplasm
- Virus Diseases
- 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
- recurrent adult acute myeloid leukemia
- recurrent adult T-cell leukemia/lymphoma
- refractory chronic lymphocytic leukemia
- refractory hairy cell leukemia
- relapsing chronic myelogenous leukemia
- secondary acute myeloid leukemia
- stage 0 chronic lymphocytic leukemia
- stage I adult T-cell leukemia/lymphoma
- stage I chronic lymphocytic leukemia
- stage II adult T-cell leukemia/lymphoma
- stage II chronic lymphocytic leukemia
- stage III adult T-cell leukemia/lymphoma
- stage III chronic lymphocytic leukemia
- stage IV adult T-cell leukemia/lymphoma
- stage IV chronic lymphocytic leukemia
- T-cell large granular lymphocyte leukemia
- recurrent adult Hodgkin lymphoma
- stage I adult Hodgkin lymphoma
- stage II adult Hodgkin lymphoma
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- anaplastic large cell lymphoma
- angioimmunoblastic T-cell lymphoma
- cutaneous B-cell non-Hodgkin lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- stage I cutaneous T-cell non-Hodgkin lymphoma
- stage II cutaneous T-cell non-Hodgkin lymphoma
- stage III cutaneous T-cell non-Hodgkin lymphoma
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- recurrent mycosis fungoides/Sezary syndrome
- stage I mycosis fungoides/Sezary syndrome
- stage II mycosis fungoides/Sezary syndrome
- stage III mycosis fungoides/Sezary syndrome
- stage IV mycosis fungoides/Sezary syndrome
- adult grade III lymphomatoid granulomatosis
- adult nasal type extranodal NK/T-cell lymphoma
- Waldenstrom macroglobulinemia
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- contiguous stage II adult Burkitt lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- contiguous stage II adult diffuse mixed cell lymphoma
- contiguous stage II adult diffuse small cleaved cell lymphoma
- contiguous stage II adult immunoblastic large cell lymphoma
- contiguous stage II adult lymphoblastic lymphoma
- contiguous stage II grade 1 follicular lymphoma
- contiguous stage II grade 2 follicular lymphoma
- contiguous stage II grade 3 follicular lymphoma
- contiguous stage II mantle cell lymphoma
- contiguous stage II marginal zone lymphoma
- contiguous stage II small lymphocytic lymphoma
- stage I adult Burkitt lymphoma
- stage I adult diffuse large cell lymphoma
- stage I adult diffuse mixed cell lymphoma
- stage I adult diffuse small cleaved cell lymphoma
- stage I adult immunoblastic large cell lymphoma
- stage I adult lymphoblastic lymphoma
- stage I grade 1 follicular lymphoma
- stage I grade 2 follicular lymphoma
- stage I grade 3 follicular lymphoma
- stage I mantle cell lymphoma
- stage I marginal zone lymphoma
- stage I small lymphocytic lymphoma
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- noncontiguous stage II mantle cell lymphoma
- noncontiguous stage II marginal zone lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- stage III adult Burkitt lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult lymphoblastic lymphoma
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III mantle cell lymphoma
- stage III marginal zone lymphoma
- stage III small lymphocytic lymphoma
- stage IV adult Burkitt lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV mantle cell lymphoma
- stage IV marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- recurrent adult Burkitt lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult grade III lymphomatoid granulomatosis
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent mantle cell lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- intraocular lymphoma
- primary central nervous system non-Hodgkin lymphoma
- primary central nervous system Hodgkin lymphoma
- post-transplant lymphoproliferative disorder
- chronic eosinophilic leukemia
- chronic neutrophilic leukemia
- primary myelofibrosis
- essential thrombocythemia
- polycythemia vera
- extramedullary plasmacytoma
- isolated plasmacytoma of bone
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- primary systemic amyloidosis
- refractory multiple myeloma
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- myelodysplastic/myeloproliferative neoplasm, unclassifiable
- Neoplasms
- Leukemia
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoproliferative Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
- Nervous System Neoplasms
- Virus Diseases
- Lymphoma, Large-Cell, Immunoblastic
- Central Nervous System Neoplasms
- Myelodysplastic-Myeloproliferative Diseases
Name | Location |
|---|---|
| City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
