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
  Purpose

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
Endpoint Classification: Efficacy Study
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.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00411541

Locations
Argentina
Department of Pediatric Hematology-Oncology, Italian Hospital
Buenos Aires, Argentina
Austria
Children's Cancer Research Institute, St Anna Kinderspital
Vienna, Austria
Belgium
Department of Pediatric Hemato-Oncology, Gent University Hospital
Gent, Belgium
Chile
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
Germany
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Hungary
Department of Pediatrics, Semmelweis University
Budapest, Hungary
Italy
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
Investigators
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

No publications provided by International BFM Study Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov 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
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Vincristine
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 29, 2014