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Vaccine Therapy in Preventing Flu in Children With Acute Lymphoblastic Leukemia
This study has been completed.
Study NCT00022035   Information provided by National Cancer Institute (NCI)
First Received: August 10, 2001   Last Updated: May 9, 2009   History of Changes

August 10, 2001
May 9, 2009
August 2000
 
 
 
Complete list of historical versions of study NCT00022035 on ClinicalTrials.gov Archive Site
 
 
 
Vaccine Therapy in Preventing Flu in Children With Acute Lymphoblastic Leukemia
Influenza Vaccine Immunogenicity in Children During and After Therapy for Acute Lymphoblastic Leukemia

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.

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.

 
Interventional
Supportive Care
  • Infection
  • Leukemia
Biological: trivalent influenza vaccine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
1 Year to 20 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00022035
 
CDR0000068742, RPCI-RP-9912, NCI-G01-1990
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Study Chair: Martin L. Brecher, MD Roswell Park Cancer Institute
National Cancer Institute (NCI)
March 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP