Pulses of Vincristine and Dexamethasone in BFM Protocols for Children With Acute Lymphoblastic Leukemia
Information source: International BFM Study Group
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Lymphoblastic Leukemia
Intervention: vincristine (Drug); dexamethasone (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: International BFM Study Group Official(s) and/or principal investigator(s):
Martin Schrappe, MD, Principal Investigator, Affiliation: BFM-G, Germany and Switzerland
Helmut Gadner, MD, Principal Investigator, Affiliation: BFM-A, Austria
Giuseppe Masera, MD, Principal Investigator, Affiliation: AIEOP, Itlay
Jan Stary, MD, Principal Investigator, Affiliation: CPH, Czech republic
Ives Benoit, MD, Principal Investigator, Affiliation: EORTC-CLG, France, Belgium, Portugal
Edina Magyarosy, MD, Principal Investigator, Affiliation: H-POG, Hungary
Myriam Campbell, MD, Principal Investigator, Affiliation: PINDA, Chile
Eduardo Dibar, MD, Principal Investigator, Affiliation: GATLA, Argentina
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
Clinical Details
Official title: Pulses of Vincristine and Dexamethasone During Maintenance in BFM Protocols for Children With Intermediate-Risk Acute Lymphoblastic Leukemia
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: disease free survival
Secondary outcome: survival
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
Minimum age: N/A.
Maximum age: 17 Years.
Gender(s): Both.
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
Locations and Contacts
Department of Pediatric Hematology-Oncology, Italian Hospital, Buenos Aires, Argentina
Children's Cancer Research Institute, St Anna Kinderspital, Vienna, Austria
Department of Pediatric Hemato-Oncology, Gent University Hospital, Gent, Belgium
Department of Pediatrics Hematology and Oncology, Hospital Roberto del Rio, Santiago, Chile
Department of Pediatric Hematology and Oncology, University Hospital Motol, Prague, Czech Republic
Medizinische Hochschule Hannover, Hannover 30625, Germany
Department of Pediatrics, Semmelweis University, Budapest, Hungary
Pediatric Clinic - University of Milano-Bicocca, Monza 20052, Italy
Additional Information
Starting date: April 1995
Ending date: January 2004
Last updated: December 13, 2006
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