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

NCT ID: NCT00411541

Last Updated: 2006-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2600 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-04-30

Study Completion Date

2004-01-31

Brief Summary

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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

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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.

Conditions

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Acute Lymphoblastic Leukemia

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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vincristine

Intervention Type DRUG

dexamethasone

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Associazione Italiana Ematologia Oncologia Pediatrica

OTHER

Sponsor Role collaborator

BFM-A, Austria

UNKNOWN

Sponsor Role collaborator

BFM-G, Germany and Switzerland

UNKNOWN

Sponsor Role collaborator

CPH, Czech republic

UNKNOWN

Sponsor Role collaborator

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role collaborator

Group for Acute Leukemia Treatment (GATLA).

OTHER

Sponsor Role collaborator

H-POG (Hungary Pediatric Oncology Group)

OTHER

Sponsor Role collaborator

PINDA, Chile

UNKNOWN

Sponsor Role collaborator

International BFM Study Group

NETWORK

Sponsor Role lead

Principal Investigators

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Martin Schrappe, MD

Role: PRINCIPAL_INVESTIGATOR

BFM-G, Germany and Switzerland

Helmut Gadner, MD

Role: PRINCIPAL_INVESTIGATOR

BFM-A, Austria

Giuseppe Masera, MD

Role: PRINCIPAL_INVESTIGATOR

AIEOP, Itlay

Jan Stary, MD

Role: PRINCIPAL_INVESTIGATOR

CPH, Czech republic

Ives Benoit, MD

Role: PRINCIPAL_INVESTIGATOR

EORTC-CLG, France, Belgium, Portugal

Edina Magyarosy, MD

Role: PRINCIPAL_INVESTIGATOR

H-POG (Hungary Pediatric Oncology Group)

Myriam Campbell, MD

Role: PRINCIPAL_INVESTIGATOR

PINDA, Chile

Eduardo Dibar, MD

Role: PRINCIPAL_INVESTIGATOR

Group for Acute Leukemia Treatment (GATLA).

Locations

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Department of Pediatric Hematology-Oncology, Italian Hospital

Buenos Aires, , Argentina

Site Status

Children's Cancer Research Institute, St Anna Kinderspital

Vienna, , Austria

Site Status

Department of Pediatric Hemato-Oncology, Gent University Hospital

Ghent, , Belgium

Site Status

Department of Pediatrics Hematology and Oncology, Hospital Roberto del Rio

Santiago, , Chile

Site Status

Department of Pediatric Hematology and Oncology, University Hospital Motol

Prague, , Czechia

Site Status

Medizinische Hochschule Hannover

Hanover, , Germany

Site Status

Department of Pediatrics, Semmelweis University

Budapest, , Hungary

Site Status

Pediatric Clinic - University of Milano-Bicocca

Monza, , Italy

Site Status

Countries

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Argentina Austria Belgium Chile Czechia Germany Hungary Italy

References

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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.

Reference Type DERIVED
PMID: 17223475 (View on PubMed)

Other Identifiers

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I-BFM-SG IR ALL

Identifier Type: -

Identifier Source: org_study_id