Pulses of Vincristine and Dexamethasone During Maintenance in BFM Protocols for Children With Intermediate-Risk Acute Lymphoblastic Leukemia
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
disease free survival
Martin Schrappe, MD
Principal Investigator
BFM-G, Germany and Switzerland
Germany: Federal Institute for Drugs and Medical Devices
I-BFM-SG IR ALL
NCT00411541
April 1995
January 2004
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