Vaccine Therapy in Preventing Flu in Children With Acute Lymphoblastic Leukemia

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00022035
First received: August 10, 2001
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

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 Intervention
Infection
Leukemia
Biological: trivalent influenza vaccine

Study Type: Interventional
Study Design: Primary Purpose: Supportive Care
Official Title: Influenza Vaccine Immunogenicity in Children During and After Therapy for Acute Lymphoblastic Leukemia

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Study Start Date: August 2000
Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   1 Year to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022035

Locations
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Study Chair: Martin L. Brecher, MD Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00022035     History of Changes
Other Study ID Numbers: RP 99-12, RPCI-RP-9912, NCI-G01-1990
Study First Received: August 10, 2001
Last Updated: January 30, 2013
Health Authority: United States: Federal Government

Keywords provided by Roswell Park Cancer Institute:
childhood acute lymphoblastic leukemia in remission
infection

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014