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Vaccine Therapy in Preventing Flu in Children With Acute Lymphoblastic Leukemia

Sponsor
Roswell Park Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00022035
Collaborator
National Cancer Institute (NCI) (NIH)
2
Locations

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: trivalent influenza vaccine
 N/A

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.

Study Design

Study Type:
Interventional
Primary Purpose:
Supportive Care
Official Title:
Influenza Vaccine Immunogenicity in Children During and After Therapy for Acute Lymphoblastic Leukemia
Study Start Date :
Aug 1, 2000
Actual Primary Completion Date :
Nov 1, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 20 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hackensack University Medical Center Hackensack New Jersey United States 07601
    2 Roswell Park Cancer Institute Buffalo New York United States 14263-0001

    Sponsors and Collaborators

    • Roswell Park Cancer Institute
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Martin L. Brecher, MD, Roswell Park Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00022035
    Other Study ID Numbers:
    • RP 99-12
    • RPCI-RP-9912
    • NCI-G01-1990
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jan 31, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by , ,
    childhood acute lymphoblastic leukemia in remission
    infection
    Additional relevant MeSH terms:
    Leukemia
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Leukemia, Lymphoid

    Study Results

    No Results Posted as of Jan 31, 2013