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Vaccine Therapy in Preventing Flu in Children With Acute Lymphoblastic Leukemia

Primary Purpose

Infection, Leukemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
trivalent influenza vaccine
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infection focused on measuring childhood acute lymphoblastic leukemia in remission, infection

Eligibility Criteria

1 Year - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hackensack University Medical Center
  • Roswell Park Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 10, 2001
Last Updated
January 30, 2013
Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00022035
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
November 2002 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Leukemia
Keywords
childhood acute lymphoblastic leukemia in remission, infection

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
trivalent influenza vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin L. Brecher, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

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Vaccine Therapy in Preventing Flu in Children With Acute Lymphoblastic Leukemia

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