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| Sponsor: | International BFM Study Group |
|---|---|
| Collaborators: |
Associazione Italiana Ematologia Oncologia Pediatrica BFM-A, Austria BFM-G, Germany and Switzerland CPH, Czech republic European Organization for Research and Treatment of Cancer GATLA, Argentina H-POG, Hungary PINDA, Chile |
| Information provided by: | International BFM Study Group |
| ClinicalTrials.gov Identifier: | NCT00411541 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Acute Lymphoblastic Leukemia |
Drug: vincristine Drug: dexamethasone |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Pulses of Vincristine and Dexamethasone During Maintenance in BFM Protocols for Children With Intermediate-Risk Acute Lymphoblastic Leukemia |
| Estimated Enrollment: | 2600 |
| Study Start Date: | April 1995 |
| Estimated Study Completion Date: | January 2004 |
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| Ages Eligible for Study: | up to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Argentina | |
| Department of Pediatric Hematology-Oncology, Italian Hospital | |
| Buenos Aires, Argentina | |
| Austria | |
| Children's Cancer Research Institute, St Anna Kinderspital | |
| Vienna, Austria | |
| Belgium | |
| Department of Pediatric Hemato-Oncology, Gent University Hospital | |
| Gent, Belgium | |
| Chile | |
| Department of Pediatrics Hematology and Oncology, Hospital Roberto del Rio | |
| Santiago, Chile | |
| Czech Republic | |
| Department of Pediatric Hematology and Oncology, University Hospital Motol | |
| Prague, Czech Republic | |
| Germany | |
| Medizinische Hochschule Hannover | |
| Hannover, Germany, 30625 | |
| Hungary | |
| Department of Pediatrics, Semmelweis University | |
| Budapest, Hungary | |
| Italy | |
| Pediatric Clinic - University of Milano-Bicocca | |
| Monza, Italy, 20052 | |
| 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 |
| Principal Investigator: | Myriam Campbell, MD | PINDA, Chile |
| Principal Investigator: | Eduardo Dibar, MD | GATLA, Argentina |
More Information
| Study ID Numbers: | I-BFM-SG IR ALL |
| Study First Received: | December 13, 2006 |
| Last Updated: | December 13, 2006 |
| ClinicalTrials.gov Identifier: | NCT00411541 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
acute lymphoblastic leukemia, maintenance, BFM protocol intermediate risk childhood acute lymphoblastic leukemia |
|
Anti-Inflammatory Agents Dexamethasone Leukemia, Lymphoid Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Leukemia Therapeutic Uses Dexamethasone acetate Immunoproliferative Disorders Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma |
Immune System Diseases Antineoplastic Agents, Hormonal Mitosis Modulators Gastrointestinal Agents Vincristine Antimitotic Agents Glucocorticoids Pharmacologic Actions Lymphatic Diseases Neoplasms Autonomic Agents Tubulin Modulators Peripheral Nervous System Agents Lymphoproliferative Disorders Antineoplastic Agents, Phytogenic |
