Acute Lymphoblastic Leukemia
Conditions
Keywords
acute lymphoblastic leukemia, maintenance, BFM protocol, intermediate risk childhood acute lymphoblastic leukemia
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 (1.5 mg/sqm weekly for 2 weeks) and dexamethasone (6 mg/sqm daily for 7 days) every 10 weeks for six cycles.
Interventions
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| survival | — |
Countries
Argentina, Austria, Belgium, Chile, Czechia, Germany, Hungary, Italy