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| 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. |
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| Detailed Description | OBJECTIVES:
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. |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Supportive Care | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Cancer-Related Problem/Condition Leukemia |
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| Intervention † | Drug: trivalent influenza vaccine | ||||
| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | |||||
| Start Date † | August 2000 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||
| Ages | 1 Year to 20 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| 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 † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | March 2003 | ||||
| First Received Date † | August 10, 2001 | ||||
| Last Updated Date | October 18, 2008 | ||||