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| Name | Class |
|---|---|
| Associazione Italiana Ematologia Oncologia Pediatrica | OTHER |
| BFM-A, Austria | UNKNOWN |
| BFM-G, Germany and Switzerland | UNKNOWN |
| CPH, Czech republic |
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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vincristine | Drug | |||
| dexamethasone | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| disease free survival |
| Measure | Description | Time Frame |
|---|---|---|
| survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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). | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatric Hematology-Oncology, Italian Hospital | Buenos Aires | Argentina | ||||
| Children's Cancer Research Institute, St Anna Kinderspital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17223475 | Derived | 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. |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D014750 | Vincristine |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
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| UNKNOWN |
| European Organisation for Research and Treatment of Cancer - EORTC | NETWORK |
| Group for Acute Leukemia Treatment (GATLA). | OTHER |
| H-POG (Hungary Pediatric Oncology Group) | OTHER |
| PINDA, Chile | UNKNOWN |
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| Vienna |
| Austria |
| Department of Pediatric Hemato-Oncology, Gent University Hospital | Ghent | Belgium |
| Department of Pediatrics Hematology and Oncology, Hospital Roberto del Rio | Santiago | Chile |
| Department of Pediatric Hematology and Oncology, University Hospital Motol | Prague | Czechia |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Department of Pediatrics, Semmelweis University | Budapest | Hungary |
| Pediatric Clinic - University of Milano-Bicocca | Monza | 20052 | Italy |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |