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| Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) Societe Francaise Oncologie Pediatrique Children's Cancer and Leukaemia Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002757 |
Purpose
RATIONALE: Less intensive therapy may attain in the same results as intensive therapy in children with non-Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to study the effectiveness of less intensive therapy for children who have non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Biological: filgrastim Drug: CHOP regimen Drug: cyclophosphamide Drug: cytarabine Drug: doxorubicin hydrochloride Drug: etoposide Drug: leucovorin calcium Drug: methotrexate Drug: prednisolone Drug: prednisone Drug: therapeutic hydrocortisone Drug: vincristine sulfate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | FAB LMB 96 -- TREATMENT OF MATURE B-CELL LYMPHOMA/LEUKAEMIA: A SFOP LMB 96/CCG 5961/UKCCSG NHL 9600 COOPERATIVE STUDY |
Eligibility| Ages Eligible for Study: | up to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
One of the following diagnoses:
Newly diagnosed B-cell non-Hodgkin's lymphoma in Revised European-American Lymphoma (REAL) categories II 9, 10, and 11, i.e.:
PATIENT CHARACTERISTICS:
Age:
Over 6 months to under 21 years
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Steroids initiated no more than 72 hours prior to entry allowed
Radiotherapy:
Surgery:
Contacts and Locations| France | |
| Institut Gustave Roussy | |
| Villejuif, France, F-94805 | |
| United Kingdom, England | |
| Children's Hospital - Sheffield | |
| Sheffield, England, United Kingdom, S10 2TH | |
| Study Chair: | Mitchell S. Cairo, MD | Herbert Irving Comprehensive Cancer Center |
| Study Chair: | Catherine Patte, MD | Institut Gustave Roussy |
| Study Chair: | Mary P. Gerrard, BSc, MBChB, FRCP, FRCPCH | Children's Hospital - Sheffield |
More Information
| Study ID Numbers: | CDR0000064702, COG-C5961, CCG-5961, SFOP-LMB-96, CCLG-NHL-9600, EU-96048 |
| Study First Received: | November 1, 1999 |
| Last Updated: | March 31, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002757 History of Changes |
| Health Authority: | United States: Federal Government |
|
Burkitt lymphoma untreated childhood acute lymphoblastic leukemia L3 childhood acute lymphoblastic leukemia stage I childhood small noncleaved cell lymphoma stage I childhood large cell lymphoma stage II childhood small noncleaved cell lymphoma |
stage II childhood large cell lymphoma stage III childhood small noncleaved cell lymphoma stage III childhood large cell lymphoma stage IV childhood small noncleaved cell lymphoma stage IV childhood large cell lymphoma |
|
Anti-Inflammatory Agents Prednisone Hydrocortisone Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Methotrexate Etoposide Methylprednisolone Hemisuccinate Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Antineoplastic Agents, Hormonal Vincristine |
Glucocorticoids Doxorubicin Folic Acid B-cell Lymphomas Hydrocortisone acetate Lymphoma, Non-Hodgkin Antineoplastic Agents, Phytogenic Acute Lymphoblastic Leukemia, Childhood Antimetabolites Leukemia, Lymphoid Immunologic Factors Folate Leucovorin Prednisolone acetate Cyclophosphamide |
|
Anti-Inflammatory Agents Prednisone Anti-Infective Agents Hydrocortisone Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Therapeutic Uses Abortifacient Agents Methotrexate Dermatologic Agents Nucleic Acid Synthesis Inhibitors Immunoproliferative Disorders |
Antineoplastic Agents, Hormonal Immune System Diseases Vincristine Abortifacient Agents, Nonsteroidal Glucocorticoids Doxorubicin Neoplasms Hydrocortisone acetate Antineoplastic Agents, Phytogenic Antimetabolites Immunologic Factors Antineoplastic Agents Leucovorin Cyclophosphamide Reproductive Control Agents |