Leukemia Clinical Trial
Official title:
Influenza Vaccine Immunogenicity in Children During and After Therapy for Acute Lymphoblastic Leukemia
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.
OBJECTIVES:
- 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.
;
Primary Purpose: Supportive Care
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