Vaccine Therapy in Preventing Flu in Children With Acute Lymphoblastic Leukemia - Tabular View

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Vaccine Therapy in Preventing Flu in Children With Acute Lymphoblastic Leukemia

This study has been completed.

Study NCT00022035. Last updated on October 18, 2008. Information provided by National Cancer Institute (NCI)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Vaccine Therapy in Preventing Flu in Children With Acute Lymphoblastic Leukemia

Official Title ^†

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

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.

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 Phase

Study Type ^†

Interventional

Study Design ^†

Supportive Care

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Cancer-Related Problem/Condition
Leukemia

Intervention ^†

Drug: trivalent influenza vaccine

MEDLINE PMIDs

Links

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

August 2000

Completion Date

Eligibility 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

Gender

Both

Ages

1 Year to 20 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00022035

Organization ID

CDR0000068742

Secondary IDs ^††

RPCI-RP-9912, NCI-G01-1990

Study Sponsor ^†

Roswell Park Cancer Institute

Collaborators ^††

National Cancer Institute (NCI)

Investigators ^†

Study Chair:

Martin L. Brecher, MD

Roswell Park Cancer Institute

Information Provided By

National Cancer Institute (NCI)

Verification Date

March 2003

First Received Date ^†

August 10, 2001

Last Updated Date

October 18, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.