Clinical trial NCT00411541: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Lymphoblastic Leukemia
Keywords: acute lymphoblastic leukemia, maintenance, BFM protocol
intermediate risk childhood acute lymphoblastic leukemia
Lead sponsor: International BFM Study Group
Sponsor class: NETWORK
Collaborators: name: Associazione Italiana Ematologia Oncologia Pediatrica
name: BFM-A, Austria
name: BFM-G, Germany and Switzerland
name: CPH, Czech republic
name: European Organisation for Research and Treatment of Cancer - EORTC
name: Group for Acute Leukemia Treatment (GATLA).
name: H-POG (Hungary Pediatric Oncology Group)
name: PINDA, Chile
First posted: 2006-12-14
Enrollment: 2600
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: disease free survival
Secondary outcomes:
measure: survival
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Department of Pediatric Hematology-Oncology, Italian Hospital
city: Vienna
country: Austria
facility: Children's Cancer Research Institute, St Anna Kinderspital
city: Gent
country: Belgium
facility: Department of Pediatric Hemato-Oncology, Gent University Hospital
city: Santiago
country: Chile
facility: Department of Pediatrics Hematology and Oncology, Hospital Roberto del Rio
city: Prague
country: Czech Republic
facility: Department of Pediatric Hematology and Oncology, University Hospital Motol
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Budapest
country: Hungary
facility: Department of Pediatrics, Semmelweis University
city: Monza
country: Italy
facility: Pediatric Clinic - University of Milano-Bicocca
Study officials:
affiliation: BFM-G, Germany and Switzerland
name: Martin Schrappe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: BFM-A, Austria
name: Helmut Gadner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AIEOP, Itlay
name: Giuseppe Masera, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CPH, Czech republic
name: Jan Stary, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: EORTC-CLG, France, Belgium, Portugal
name: Ives Benoit, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: H-POG (Hungary Pediatric Oncology Group)
name: Edina Magyarosy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: PINDA, Chile
name: Myriam Campbell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Group for Acute Leukemia Treatment (GATLA).
name: Eduardo Dibar, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.