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

NCT00411541 | Completed Phase 4

• 1 other identifier: I-BFM-SG IR ALL
• Study Type: interventional
• Target: 2,600
• Locations: 8 countries
• Sites: 8

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

Conditions

Acute Lymphoblastic Leukemia

Keywords

acute lymphoblastic leukemia, maintenance, BFM protocol; intermediate risk childhood acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (1)

• disease free survival

Secondary Outcomes (1)

• survival

Interventions

vincristine DRUG

dexamethasone DRUG

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age \<1 or \>5 years or
• white blood cell count at diagnosis \>=20000

You may not qualify if:

• prednisone poor response
• no complete remission at the end of induction (IA)
• t(9,22) clonal translocation
• t(4,11) clonal translocation

Sponsors & Collaborators

• International BFM Study Group: lead
• Associazione Italiana Ematologia Oncologia Pediatrica: collaborator
• BFM-A, Austria: collaborator
• BFM-G, Germany and Switzerland: collaborator
• CPH, Czech republic: collaborator
• European Organisation for Research and Treatment of Cancer - EORTC: collaborator
• Group for Acute Leukemia Treatment (GATLA).: collaborator
• H-POG (Hungary Pediatric Oncology Group): collaborator
• PINDA, Chile: collaborator

Study Sites (8)

Department of Pediatric Hematology-Oncology, Italian Hospital

Buenos Aires, Argentina

Location

Children's Cancer Research Institute, St Anna Kinderspital

Vienna, Austria

Location

Department of Pediatric Hemato-Oncology, Gent University Hospital

Ghent, Belgium

Location

Department of Pediatrics Hematology and Oncology, Hospital Roberto del Rio

Santiago, Chile

Location

Department of Pediatric Hematology and Oncology, University Hospital Motol

Prague, Czechia

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Department of Pediatrics, Semmelweis University

Budapest, Hungary

Location

Pediatric Clinic - University of Milano-Bicocca

Monza, 20052, Italy

Location

Related Publications (1)

• 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.

  PMID: 17223475 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Vincristine; Dexamethasone

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• 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).

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: December 13, 2006
• First Posted: December 14, 2006
• Study Start: April 1, 1995
• Study Completion: January 1, 2004
• Last Updated: December 14, 2006

Record last verified: 2006-12

Locations

CZ (1); HU (1); AU (1); DE (1); IT (1); AR (1); BE (1); CL (1)