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

This study has been completed.
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 Identifier:
First received: December 13, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
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

Condition Intervention Phase
Acute Lymphoblastic Leukemia
Drug: vincristine
Drug: dexamethasone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pulses of Vincristine and Dexamethasone During Maintenance in BFM Protocols for Children With Intermediate-Risk Acute Lymphoblastic Leukemia

Resource links provided by NLM:

Further study details as provided by International BFM Study Group:

Primary Outcome Measures:
  • disease free survival

Secondary Outcome Measures:
  • survival

Estimated Enrollment: 2600
Study Start Date: April 1995
Estimated Study Completion Date: January 2004
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.

Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00411541

Department of Pediatric Hematology-Oncology, Italian Hospital
Buenos Aires, Argentina
Children's Cancer Research Institute, St Anna Kinderspital
Vienna, Austria
Department of Pediatric Hemato-Oncology, Gent University Hospital
Gent, Belgium
Department of Pediatrics Hematology and Oncology, Hospital Roberto del Rio
Santiago, Chile
Czech Republic
Department of Pediatric Hematology and Oncology, University Hospital Motol
Prague, Czech Republic
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Department of Pediatrics, Semmelweis University
Budapest, Hungary
Pediatric Clinic - University of Milano-Bicocca
Monza, Italy, 20052
Sponsors and Collaborators
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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00411541     History of Changes
Other Study ID Numbers: I-BFM-SG IR ALL
Study First Received: December 13, 2006
Last Updated: December 13, 2006

Keywords provided by International BFM Study Group:
acute lymphoblastic leukemia, maintenance, BFM protocol
intermediate risk childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators processed this record on April 28, 2017