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| Sponsored by: |
European Organization for Research and Treatment of Cancer |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003728 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy plus steroid therapy is more effective for acute lymphoblastic leukemia or lymphoblastic non-Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy plus steroid therapy in treating children who have acute lymphoblastic leukemia or lymphoblastic non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|
Leukemia Lymphoma |
Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: etoposide Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: methylprednisolone Drug: mitoxantrone hydrochloride Drug: prednisolone Drug: therapeutic hydrocortisone Drug: thioguanine Drug: vincristine Drug: vindesine Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation |
Phase III |
| MedlinePlus related topics: | Bone Marrow Transplantation Cancer Leukemia, Childhood Lymphoma |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | The Value of Dexamethasone Versus Prednisolone During Induction and Maintenance Therapy of Prolonged Versus Conventional Duration of L-Asparaginase Therapy During Consolidation and Late Intensification, and of Corticosteroid + VCR Pulses During Maintenance in Acute Lymphoblastic Leukemia and Lymphoblastic Non-Hodgkin Lymphoma of Childhood |
| Estimated Enrollment: | 1500 |
| Study Start Date: | December 1998 |
| Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | up to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed acute lymphoblastic leukemia (ALL) of FAB L1 or L2 morphology
Histologically confirmed precursor B or precursor T lymphoblastic non-Hodgkin's lymphoma (NHL)
Very low-risk (VLR) patients meeting 1 of the following criteria:
ALL of B-cell lineage
Must meet 1 of the following conditions:
Average risk (AR) patients:
Must meet 1 of the following criteria:
AR patients substratified in:
AR1: B-cell lineage ALL with WBC less than 100,000/mm^3
AR2: B-cell lineage ALL with WBC at least 100,000/mm^3
VHR patients:
Must meet 1 of the following criteria:
ALL patients meeting 1 of the following conditions:
All VHR patients are eligible for stem cell transplantation except those whose sole VHR criterion is a poor response to prephase therapy and who have none of the following features:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| Belgium | |||||
| Academisch Ziekenhuis der Vrije Universiteit Brussel | Recruiting | ||||
| Brussels, Belgium, 1090 | |||||
| Contact: Contact Person 32-2-477-6040 | |||||
| Centre Hospitalier Regional de la Citadelle | Recruiting | ||||
| Liege, Belgium, 4000 | |||||
| Contact: Contact Person 32-4-225-6111 | |||||
| Clinique de l'Esperance | Recruiting | ||||
| Montegnee, Belgium, 4420 | |||||
| Contact: Contact Person 32-4-224-9111 | |||||
| Ghent University | Recruiting | ||||
| Ghent, Belgium, B-9000 | |||||
| Contact: Contact Person Not Available | |||||
| Hopital Universitaire Des Enfants Reine Fabiola | Recruiting | ||||
| Brussels, Belgium, 1020 | |||||
| Contact: Contact Person 32-2-477-3282 | |||||
| U.Z. Gasthuisberg | Recruiting | ||||
| Leuven, Belgium, B-3000 | |||||
| Contact: Contact Person 32-16-332-211 | |||||
| Universitair Ziekenhuis Gent | Recruiting | ||||
| Ghent, Belgium, B-9000 | |||||
| Contact: Contact Person 32-9-240-2011 | |||||
| Ziekenhuis Netwerk Antwerpen Middelheim | Recruiting | ||||
| Antwerp, Belgium, 2020 | |||||
| Contact: Contact Person 32-3-280-3111 | |||||
| France | |||||
| Centre Hospitalier Regional et Universitaire d'Angers | Recruiting | ||||
| Angers, France, 49033 | |||||
| Contact: Contact Person 33-2-4148-1066 | |||||
| CHR de Besancon - Hopital Saint-Jacques | Recruiting | ||||
| Besancon, France, 25030 | |||||
| Contact: Contact Person 33-3-8166-8166 | |||||
| CHR Hotel Dieu | Recruiting | ||||
| Nantes, France, 44035 | |||||
| Contact: Contact Person 33-240-083-272 | |||||
| CHU - Hopital Robert Debre | Recruiting | ||||
| Paris, France, 75019 | |||||
| Contact: Contact Person 33-1-4003-2350 | |||||
| CHU de Caen | Recruiting | ||||
| Caen, France, 14033 | |||||
| Contact: Contact Person 33-2-3106-3106 | |||||
| CHU de Grenoble - Hopital de la Tronche | Recruiting | ||||
| Grenoble, France, 38043 | |||||
| Contact: Contact Person 33-476-767-575 | |||||
| Hopital Americain | Recruiting | ||||
| Reims, France, 51092 | |||||
| Contact: Contact Person 33-326-787-789 | |||||
| Hopital Arnaud de Villeneuve | Recruiting | ||||
| Montpellier, France, 34059 | |||||
| Contact: Contact Person 33-467-336-733 | |||||
| Hopital de l'Archet CHU de Nice | Recruiting | ||||
| Nice, France, F-06202 | |||||
| Contact: Contact Person 33-492-035-555 | |||||
| Hopital Debrousse | Recruiting | ||||
| Lyon, France, 69322 | |||||
| Contact: Contact Person 33-472-385-757 | |||||
| Hopital des Enfants | Recruiting | ||||
| Toulouse, France, 31026 | |||||
| Contact: Contact Person 33-561-05345-58584 | |||||
| Hopital Jean Bernard | Recruiting | ||||
| Poitiers, France, 86021 | |||||
| Contact: Contact Person 33-5-4944-4444 | |||||
| Hopital Universitaire Hautepierre | Recruiting | ||||
| Strasbourg, France, 67098 | |||||
| Contact: Contact Person 33-388-128-000 | |||||
| Portugal | |||||
| Hospital Escolar San Joao | Recruiting | ||||
| Porto, Portugal, 4200 | |||||
| Contact: Contact Person 351-2-502-7151 | |||||
| Instituto Portugues de Oncologia Centro do Porto, SA | Recruiting | ||||
| Porto, Portugal, 4200 | |||||
| Contact: Contact Person 351-2-550-2011 | |||||
| European Organization for Research and Treatment of Cancer |
| Investigator: | Jacques Otten, MD | Academisch Ziekenhuis der Vrije Universiteit Brussel |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Bertrand Y, Goutagny MP, Poulat AL, et al.: Asparagine depletion, safety and antibody production after E coli asparaginase treatment in children with newly diagnosed acute lymphoblastic leukaemia treated with EORTC 58951 protocol: a single center report. [Abstract] Blood 110 (11): A-4337, 2007. |
| Study ID Numbers: | CDR0000066840, EORTC-58951 |
| First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003728 |
| Health Authority: | Unspecified |
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