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

Sponsor

International BFM Study Group (Other)

Overall Status

Completed

CT.gov ID

NCT00411541

Collaborator

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

2,600

Enrollment

Locations

105

Duration (Months)

325

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia	Drug: vincristine Drug: dexamethasone	Phase 4

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pulses of Vincristine and Dexamethasone During Maintenance in BFM Protocols for Children With Intermediate-Risk Acute Lymphoblastic Leukemia

Study Start Date :

Apr 1, 1995

Study Completion Date :

Jan 1, 2004

Outcome Measures

Primary Outcome Measures

disease free survival []

Secondary Outcome Measures

survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 17 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Department of Pediatric Hematology-Oncology, Italian Hospital	Buenos Aires	Argentina
2	Children's Cancer Research Institute, St Anna Kinderspital	Vienna	Austria
3	Department of Pediatric Hemato-Oncology, Gent University Hospital	Gent	Belgium
4	Department of Pediatrics Hematology and Oncology, Hospital Roberto del Rio	Santiago	Chile
5	Department of Pediatric Hematology and Oncology, University Hospital Motol	Prague	Czech Republic
6	Medizinische Hochschule Hannover	Hannover	Germany	30625
7	Department of Pediatrics, Semmelweis University	Budapest	Hungary
8	Pediatric Clinic - University of Milano-Bicocca	Monza	Italy	20052

Sponsors and Collaborators

International BFM Study Group
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

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).