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


N/A
1 Year
20 Years
Not Enrolling
Both
Infection, Leukemia

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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 InstituteBuffalo, New York  14263
Hackensack University Medical CenterHackensack, New Jersey  07601