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

Primary Purpose

Acute Lymphoblastic Leukemia

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
vincristine
dexamethasone
Sponsored by
International BFM Study Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring acute lymphoblastic leukemia, maintenance, BFM protocol, intermediate risk childhood acute lymphoblastic leukemia

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Pediatric Hematology-Oncology, Italian Hospital
  • Children's Cancer Research Institute, St Anna Kinderspital
  • Department of Pediatric Hemato-Oncology, Gent University Hospital
  • Department of Pediatrics Hematology and Oncology, Hospital Roberto del Rio
  • Department of Pediatric Hematology and Oncology, University Hospital Motol
  • Medizinische Hochschule Hannover
  • Department of Pediatrics, Semmelweis University
  • Pediatric Clinic - University of Milano-Bicocca

Outcomes

Primary Outcome Measures

disease free survival

Secondary Outcome Measures

survival

Full Information

First Posted
December 13, 2006
Last Updated
December 13, 2006
Sponsor
International BFM Study Group
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, Group for Acute Leukemia Treatment (GATLA)., H-POG (Hungary Pediatric Oncology Group), PINDA, Chile
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1. Study Identification

Unique Protocol Identification Number
NCT00411541
Brief Title
Pulses of Vincristine and Dexamethasone in BFM Protocols for Children With Acute Lymphoblastic Leukemia
Official Title
Pulses of Vincristine and Dexamethasone During Maintenance in BFM Protocols for Children With Intermediate-Risk Acute Lymphoblastic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
April 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
International BFM Study Group
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, Group for Acute Leukemia Treatment (GATLA)., H-POG (Hungary Pediatric Oncology Group), PINDA, Chile

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia
Keywords
acute lymphoblastic leukemia, maintenance, BFM protocol, intermediate risk childhood acute lymphoblastic leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2600 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
vincristine
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Primary Outcome Measure Information:
Title
disease free survival
Secondary Outcome Measure Information:
Title
survival

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Schrappe, MD
Organizational Affiliation
BFM-G, Germany and Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helmut Gadner, MD
Organizational Affiliation
BFM-A, Austria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Giuseppe Masera, MD
Organizational Affiliation
AIEOP, Itlay
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan Stary, MD
Organizational Affiliation
CPH, Czech republic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ives Benoit, MD
Organizational Affiliation
EORTC-CLG, France, Belgium, Portugal
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edina Magyarosy, MD
Organizational Affiliation
H-POG (Hungary Pediatric Oncology Group)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Myriam Campbell, MD
Organizational Affiliation
PINDA, Chile
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eduardo Dibar, MD
Organizational Affiliation
Group for Acute Leukemia Treatment (GATLA).
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatric Hematology-Oncology, Italian Hospital
City
Buenos Aires
Country
Argentina
Facility Name
Children's Cancer Research Institute, St Anna Kinderspital
City
Vienna
Country
Austria
Facility Name
Department of Pediatric Hemato-Oncology, Gent University Hospital
City
Gent
Country
Belgium
Facility Name
Department of Pediatrics Hematology and Oncology, Hospital Roberto del Rio
City
Santiago
Country
Chile
Facility Name
Department of Pediatric Hematology and Oncology, University Hospital Motol
City
Prague
Country
Czech Republic
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Department of Pediatrics, Semmelweis University
City
Budapest
Country
Hungary
Facility Name
Pediatric Clinic - University of Milano-Bicocca
City
Monza
ZIP/Postal Code
20052
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
17223475
Citation
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. doi: 10.1016/S0140-6736(07)60073-7.
Results Reference
derived

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

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