Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022035
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
2001-08-10
Brief Title:
Vaccine Therapy in Preventing Flu in Children With Acute Lymphoblastic Leukemia
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Influenza Vaccine Immunogenicity in Children During and After Therapy for Acute Lymphoblastic Leukemia
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G01-1990 | None | None | None |
| RPCI-RP-9912 | None | None | None |