drugset / Trial / NCT00411541
Pulses of Vincristine and Dexamethasone in BFM Protocols for Children With Acute Lymphoblastic Leukemia
Phase 4
Completed
2600 enrolled
International BFM Study Group
Associazione Italiana Ematologia Oncologia Pediatrica · collabBFM-A, Austria · collabBFM-G, Germany and Switzerland · collabCPH, Czech republic · collabEuropean Organisation for Research and Treatment of Cancer - EORTC · collabGroup for Acute Leukemia Treatment (GATLA). · collabH-POG (Hungary Pediatric Oncology Group) · collabPINDA, Chile · collab
RandomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 1995-04
- Primary completion
- —
- Completion
- 2004-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 6 mg/m2 | — |
| Subject | Vincristine | Small molecule | 1.5 mg/m2 | — |