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

This study has been completed.
Sponsor:
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
H-POG, Hungary
PINDA, Chile
Information provided by:
International BFM Study Group
ClinicalTrials.gov Identifier:
NCT00411541
First received: December 13, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted

December 13, 2006
December 13, 2006
April 1995
Not Provided
disease free survival
Same as current
No Changes Posted
survival
Same as current
Not Provided
Not Provided
 
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

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Lymphoblastic Leukemia
  • Drug: vincristine
  • Drug: dexamethasone
Not Provided
Conter V, Valsecchi MG, Silvestri D, Campbell M, Dibar E, Magyarosy E, Gadner H, Stary J, Benoit Y, Zimmermann M, Reiter A, Riehm H, Masera G, Schrappe M. Pulses of vincristine and dexamethasone in addition to intensive chemotherapy for children with intermediate-risk acute lymphoblastic leukaemia: a multicentre randomised trial. Lancet. 2007 Jan 13;369(9556):123-31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2600
January 2004
Not Provided

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
Both
up to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Austria,   Belgium,   Chile,   Czech Republic,   Germany,   Hungary,   Italy
 
NCT00411541
I-BFM-SG IR ALL
Not Provided
Not Provided
International BFM Study Group
  • 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
  • H-POG, Hungary
  • PINDA, Chile
Principal Investigator: Martin Schrappe, MD BFM-G, Germany and Switzerland
Principal Investigator: Helmut Gadner, MD BFM-A, Austria
Principal Investigator: Giuseppe Masera, MD AIEOP, Itlay
Principal Investigator: Jan Stary, MD CPH, Czech republic
Principal Investigator: Ives Benoit, MD EORTC-CLG, France, Belgium, Portugal
Principal Investigator: Edina Magyarosy, MD H-POG, Hungary
Principal Investigator: Myriam Campbell, MD PINDA, Chile
Principal Investigator: Eduardo Dibar, MD GATLA, Argentina
International BFM Study Group
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP