Pulses of Vincristine and Dexamethasone in BFM Protocols for Children With Acute Lymphoblastic Leukemia
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ClinicalTrials.gov Identifier: NCT00411541
: December 14, 2006
Last Update Posted
: December 14, 2006
International BFM Study Group
Associazione Italiana Ematologia Oncologia Pediatrica
BFM-G, Germany and Switzerland
CPH, Czech republic
European Organisation for Research and Treatment of Cancer - EORTC
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
Condition or disease
Acute Lymphoblastic Leukemia
Drug: vincristineDrug: dexamethasone
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.
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Ages Eligible for Study:
up to 17 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
age <1 or >5 years or
white blood cell count at diagnosis >=20000
prednisone poor response
no complete remission at the end of induction (IA)