Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00411541
Status:
COMPLETED
Last Update Posted:
2006-12-14
First Post:
2006-12-13
Brief Title:
Pulses of Vincristine and Dexamethasone in BFM Protocols for Children With Acute Lymphoblastic Leukemia
Sponsor:
International BFM Study Group
Organization:
International BFM Study Group
Study Overview
Official Title:
Pulses of Vincristine and Dexamethasone During Maintenance in BFM Protocols for Children With Intermediate-Risk Acute Lymphoblastic Leukemia
Status:
COMPLETED
Status Verified Date:
2006-12
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:
Studies in the 1970s and 1980s suggested that the outcome of childhood acute lymphoblastic leukemia could be improved by intensification of conventional continuation chemotherapy with pulses of vincristine sulfate and steroids We aimed to investigate the efficacy and toxic effects of vincristine-dexamethasone pulses as an addition to the continuation-therapy phase in a large cohort of children with intermediate-risk disease who were treated with the BFM treatment strategy
Detailed Description:
The study enrols children from 8 participating organizations All children are treated with similar protocols based on the BFM treatment strategy which include induction consolidation reinduction and continuation-therapy phases At the beginning of the continuation-therapy phase those patients in complete remission are randomly assigned to either a treatment or a control group Control patients are given conventional mercaptopurine and methotrexate chemotherapy only Patients in the treatment arm are also given pulses of vincristine 15 mgsqm weekly for 2 weeks and dexamethasone 6 mgsqm daily for 7 days every 10 weeks for six cycles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None