Pulses of Vincristine and Dexamethasone in BFM Protocols for Children With Acute Lymphoblastic Leukemia
- Conditions
- Acute Lymphoblastic Leukemia
- Registration Number
- NCT00411541
- Lead Sponsor
- International BFM Study Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2600
- 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)
- t(9,22) clonal translocation
- t(4,11) clonal translocation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method disease free survival
- Secondary Outcome Measures
Name Time Method survival
Trial Locations
- Locations (8)
Department of Pediatric Hematology-Oncology, Italian Hospital
🇦🇷Buenos Aires, Argentina
Department of Pediatric Hemato-Oncology, Gent University Hospital
🇧🇪Gent, Belgium
Children's Cancer Research Institute, St Anna Kinderspital
🇦🇹Vienna, Austria
Department of Pediatrics Hematology and Oncology, Hospital Roberto del Rio
🇨🇱Santiago, Chile
Department of Pediatric Hematology and Oncology, University Hospital Motol
🇨🇿Prague, Czech Republic
Department of Pediatrics, Semmelweis University
ðŸ‡ðŸ‡ºBudapest, Hungary
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Pediatric Clinic - University of Milano-Bicocca
🇮🇹Monza, Italy