Vaccine Therapy in Preventing Flu in Children With Acute Lymphoblastic Leukemia

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00022035
• Other study ID #: RP 99-12
• Secondary ID: RPCI-RP-9912NCI-
• Status: Completed
• Phase: N/A
• First received: August 10, 2001
• Last updated: January 30, 2013
• Start date: August 2000

Study information

• Verified date: January 2013
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: November 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 20 Years

Eligibility

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

Study Design

Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Infection
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Biological:
• trivalent influenza vaccine

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Hackensack University Medical Center	Hackensack	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,