Spots Global Cancer Trial Database for Vaccine Therapy in Preventing Flu in Children With Acute Lymphoblastic Leukemia

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Trial Identification

Brief Title: Vaccine Therapy in Preventing Flu in Children With Acute Lymphoblastic Leukemia

Official Title: Influenza Vaccine Immunogenicity in Children During and After Therapy for Acute Lymphoblastic Leukemia

Study ID: NCT00022035

Conditions

Infection

Leukemia

Interventions

trivalent influenza vaccine

Study Description

Brief Summary: 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.

Detailed Description: 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.