Influenza Vaccine Immunogenicity in Children During and After Therapy for Acute Lymphoblastic Leukemia
1 Year
20 Years
Both
Infection, Leukemia
Trial Information
Influenza Vaccine Immunogenicity in Children During and After Therapy for 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of acute lymphoblastic leukemia
- In first remission after completion of induction chemotherapy
- Currently on active treatment OR
- Completed treatment within the past 6 months
PATIENT CHARACTERISTICS:
Age:
- 1 to 20 at time of diagnosis
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Pulmonary:
- No acute respiratory distress
Other:
- No history of Guillain-Barre syndrome
- No history of hypersensitivity to chicken eggs, egg products, or components of
influenza virus vaccine, including thimerosal
- No febrile illness with fever over 100.4 degrees F
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- At least 7 days since prior antibiotic or antiviral therapy except prophylactic
antibiotics
Type of Study:
Interventional
Study Design:
Primary Purpose: Supportive Care
Principal Investigator
Martin L. Brecher, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Federal Government
Study ID:
RP 99-12
NCT ID:
NCT00022035
Start Date:
August 2000
Completion Date:
Related Keywords:
- Infection
- Leukemia
- childhood acute lymphoblastic leukemia in remission
- infection
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Hackensack University Medical Center | Hackensack, New Jersey 07601 |
