Trial | NCT00411541  Report issue

Title

Pulses of Vincristine and Dexamethasone in BFM Protocols for Children With Acute Lymphoblastic Leukemia
Pulses of Vincristine and Dexamethasone During Maintenance in BFM Protocols for Children With Intermediate-Risk Acute Lymphoblastic Leukemia

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    2600
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.
Study Started
Apr 30
1995
Study Completion
Jan 31
2004
Last Update
Dec 14
2006
Estimate

Drug vincristine

Drug dexamethasone

Criteria 

Inclusion Criteria:

age <1 or >5 years or
white blood cell count at diagnosis >=20000

Exclusion Criteria:

prednisone poor response
no complete remission at the end of induction (IA)
t(9,22) clonal translocation
t(4,11) clonal translocation
No Results Posted