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

December 13, 2006 updated by: International BFM Study Group

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

2600

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
disease free survival

Secondary Outcome Measures

Outcome Measure
survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International BFM Study Group

Collaborators

European Organisation for Research and Treatment of Cancer - EORTC
Associazione Italiana Ematologia Oncologia Pediatrica
BFM-A, Austria
BFM-G, Germany and Switzerland
CPH, Czech republic
Group for Acute Leukemia Treatment (GATLA).
H-POG (Hungary Pediatric Oncology Group)
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 Pediatric Oncology Group)
  • Principal Investigator: Myriam Campbell, MD, PINDA, Chile
  • Principal Investigator: Eduardo Dibar, MD, Group for Acute Leukemia Treatment (GATLA).

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1995

Study Completion

January 1, 2004

Study Registration Dates

First Submitted

December 13, 2006

First Submitted That Met QC Criteria

December 13, 2006

First Posted (Estimate)

December 14, 2006

Study Record Updates

Last Update Posted (Estimate)

December 14, 2006

Last Update Submitted That Met QC Criteria

December 13, 2006

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I-BFM-SG IR ALL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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