A Phase 4 interventional study of vincristine and dexamethasone in Acute Lymphoblastic Leukemia, sponsored by International BFM Study Group. Completed at 8 sites in 8 countries. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2006-12-14.
Sponsored by International BFM Study Group · Phase 4, Interventional, and Treatment
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
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 (1.5 mg/sqm weekly for 2 weeks) and dexamethasone (6 mg/sqm daily for 7 days) every 10 weeks for six cycles.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 2,600 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →This is the only study on the registry with International BFM Study Group as lead sponsor.
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Exclusion Criteria:
disease free survival
survival
This study is completed, as verified in Dec 2006. You cannot join it, but the record below documents what was studied.
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