Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
European Organization for Research and Treatment of Cancer |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003728 |
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: | 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) |
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:
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 |
Investigator: | Jacques Otten, MD | Academisch Ziekenhuis der Vrije Universiteit Brussel |
Study ID Numbers: | CDR0000066840, EORTC-58951 |
Study First Received: | November 1, 1999 |
Last Updated: | June 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00003728 History of Changes |
Health Authority: | Unspecified |
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 |
Anti-Inflammatory Agents Dexamethasone Anti-Infective Agents Hydrocortisone Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics 6-Mercaptopurine Hormones Methotrexate Etoposide Methylprednisolone Hemisuccinate Asparaginase Precursor Cell Lymphoblastic Leukemia-Lymphoma |
Immunoproliferative Disorders Antineoplastic Agents, Hormonal Thioguanine Vincristine Glucocorticoids Doxorubicin Folic Acid Hydrocortisone acetate Mitoxantrone Lymphoma, Non-Hodgkin Antineoplastic Agents, Phytogenic Acute Lymphoblastic Leukemia, Childhood Antimetabolites Daunorubicin Leukemia, Lymphoid |
Anti-Inflammatory Agents Dexamethasone Anti-Infective Agents Hydrocortisone Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics 6-Mercaptopurine Hormones Therapeutic Uses Abortifacient Agents Methotrexate |
Dermatologic Agents Nucleic Acid Synthesis Inhibitors Methylprednisolone Hemisuccinate Asparaginase Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Antineoplastic Agents, Hormonal Immune System Diseases Thioguanine Vincristine Abortifacient Agents, Nonsteroidal Glucocorticoids Doxorubicin Neoplasms Mitoxantrone |