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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 - EORTC 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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
| 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
| ClinicalTrials.gov Identifier: | NCT00411541 History of Changes |
| Other Study ID Numbers: | I-BFM-SG IR ALL |
| Study First Received: | December 13, 2006 |
| Last Updated: | December 13, 2006 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
acute lymphoblastic leukemia, maintenance, BFM protocol intermediate risk childhood acute lymphoblastic leukemia |
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate Vincristine BB 1101 Anti-Inflammatory Agents |
Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors |
