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| Sponsor: | European Organization for Research and Treatment of Cancer - EORTC |
|---|---|
| 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 sulfate Drug: vindesine Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| 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) |
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 | |
| Ziekenhuis Netwerk Antwerpen Middelheim | |
| Antwerp, Belgium, 2020 | |
| Academisch Ziekenhuis der Vrije Universiteit Brussel | |
| Brussels, Belgium, 1090 | |
| Hopital Universitaire Des Enfants Reine Fabiola | |
| Brussels, Belgium, 1020 | |
| Ghent University | |
| Ghent, Belgium, B-9000 | |
| Universitair Ziekenhuis Gent | |
| Ghent, Belgium, B-9000 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Centre Hospitalier Regional de la Citadelle | |
| Liege, Belgium, 4000 | |
| Clinique de l'Esperance | |
| Montegnee, Belgium, 4420 | |
| France | |
| Centre Hospitalier Regional et Universitaire d'Angers | |
| Angers, France, 49033 | |
| CHR de Besancon - Hopital Saint-Jacques | |
| Besancon, France, 25030 | |
| CHU de Caen | |
| Caen, France, 14033 | |
| CHU de Grenoble - Hopital de la Tronche | |
| Grenoble, France, 38043 | |
| Hopital Debrousse | |
| Lyon, France, 69322 | |
| Hopital Arnaud de Villeneuve | |
| Montpellier, France, 34059 | |
| CHR Hotel Dieu | |
| Nantes, France, 44035 | |
| Hopital de l'Archet CHU de Nice | |
| Nice, France, F-06202 | |
| CHU - Hopital Robert Debre | |
| Paris, France, 75019 | |
| Hopital Jean Bernard | |
| Poitiers, France, 86021 | |
| Hopital Americain | |
| Reims, France, 51092 | |
| Hopital Universitaire Hautepierre | |
| Strasbourg, France, 67098 | |
| Hopital des Enfants | |
| Toulouse, France, 31026 | |
| Portugal | |
| Instituto Portugues de Oncologia Centro do Porto, SA | |
| Porto, Portugal, 4200 | |
| Hospital Escolar San Joao | |
| Porto, Portugal, 4200 | |
| Investigator: | Jacques Otten, MD | Academisch Ziekenhuis der Vrije Universiteit Brussel |
More Information
| ClinicalTrials.gov Identifier: | NCT00003728 History of Changes |
| Other Study ID Numbers: | CDR0000066840, EORTC-58951 |
| Study First Received: | November 1, 1999 |
| Last Updated: | January 20, 2011 |
| Health Authority: | United States: Federal Government |
|
stage I childhood lymphoblastic lymphoma stage II childhood lymphoblastic lymphoma stage III childhood lymphoblastic lymphoma stage IV childhood lymphoblastic lymphoma untreated childhood acute lymphoblastic leukemia |
L1 childhood acute lymphoblastic leukemia L2 childhood acute lymphoblastic leukemia T-cell childhood acute lymphoblastic leukemia B-cell childhood acute lymphoblastic leukemia acute undifferentiated leukemia |
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases 6-Mercaptopurine Cytarabine Methotrexate Thioguanine |
Cyclophosphamide Asparaginase Daunorubicin Dexamethasone Doxorubicin Etoposide Prednisolone Methylprednisolone Hemisuccinate Mitoxantrone Vincristine Vindesine BB 1101 Dexamethasone acetate Cortisol succinate Hydrocortisone acetate |