Pulses of Vincristine and Dexamethasone in BFM Protocols for Children With Acute Lymphoblastic Leukemia

• Status: Completed
• Trial end date: 2004-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: International BFM Study Group
• Collaborators: Associazione Italiana Ematologia Oncologia Pediatrica; BFM-A, Austria; BFM-G, Germany and Switzerland; CPH, Czech republic; European Organisation for Research and Treatment of Cancer - EORTC; GATLA, Argentina; Group for Acute Leukemia Treatment (GATLA).; H-POG (Hungary Pediatric Oncology Group); H-POG, Hungary; PINDA, Chile
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Vincristine

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