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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00411541
Enrollment
2600
Registered
2006-12-14
Start date
1995-04-30
Completion date
2004-01-31
Last updated
2006-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia

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

DRUGvincristine
DRUGdexamethasone

Sponsors

Associazione Italiana Ematologia Oncologia Pediatrica
CollaboratorOTHER
BFM-A, Austria
CollaboratorUNKNOWN
BFM-G, Germany and Switzerland
CollaboratorUNKNOWN
CPH, Czech republic
CollaboratorUNKNOWN
European Organisation for Research and Treatment of Cancer - EORTC
CollaboratorNETWORK
Group for Acute Leukemia Treatment (GATLA).
CollaboratorOTHER
H-POG (Hungary Pediatric Oncology Group)
CollaboratorOTHER
PINDA, Chile
CollaboratorUNKNOWN
International BFM Study Group
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No

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

MeasureTime frame
disease free survival

Secondary

MeasureTime frame
survival

Countries

Argentina, Austria, Belgium, Chile, Czechia, Germany, Hungary, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026