Vaccine Therapy in Preventing Flu in Children With Acute Lymphoblastic Leukemia
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|ClinicalTrials.gov Identifier: NCT00022035|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 31, 2013
RATIONALE: Flu vaccine may help the body build an immune response and decrease the occurrence of flu in children who are receiving chemotherapy for acute lymphoblastic leukemia.
PURPOSE: Clinical trial to study the effectiveness of vaccine therapy in preventing flu in children who have acute lymphoblastic leukemia.
|Condition or disease||Intervention/treatment||Phase|
|Infection Leukemia||Biological: trivalent influenza vaccine||Not Applicable|
- Determine the immune response, in terms of the formation of protective antibody titers to influenza, in children with acute lymphoblastic leukemia treated with split-virus trivalent influenza vaccine.
- Correlate the formation of protective antibody titers following immunization with the absolute neutrophil counts and absolute lymphocyte counts in these patients at the time of vaccination.
OUTLINE: This is a multicenter study. Patients are stratified according to current treatment for acute lymphoblastic leukemia (consolidation chemotherapy vs maintenance chemotherapy vs off therapy for the past 6 months).
Patients receive split-virus trivalent influenza vaccine intramuscularly once or twice at 4 weeks apart for 2 doses.
Patients are followed at week 5. Patients receiving 2 doses of vaccine are also followed at week 9.
PROJECTED ACCRUAL: A total of 175 patients (50 receiving consolidation therapy, 75 receiving maintenance therapy, and 50 off therapy) will be accrued for this study within 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Primary Purpose:||Supportive Care|
|Official Title:||Influenza Vaccine Immunogenicity in Children During and After Therapy for Acute Lymphoblastic Leukemia|
|Study Start Date :||August 2000|
|Actual Primary Completion Date :||November 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00022035
|United States, New Jersey|
|Hackensack University Medical Center|
|Hackensack, New Jersey, United States, 07601|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Study Chair:||Martin L. Brecher, MD||Roswell Park Cancer Institute|