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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 |
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 |
Drug: cyclophosphamide Drug: cytarabine Drug: doxorubicin hydrochloride Drug: etoposide Drug: filgrastim Drug: leucovorin calcium Drug: methotrexate Drug: prednisolone Drug: prednisone Drug: therapeutic hydrocortisone Drug: vincristine sulfate |
Phase III |
MedlinePlus related topics: | Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma |
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 |
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:
France | |||||
Institut Gustave Roussy | |||||
Villejuif, France, F-94805 | |||||
United Kingdom, England | |||||
Children's Hospital - Sheffield | |||||
Sheffield, England, United Kingdom, S10 2TH |
Children's Oncology Group |
National Cancer Institute (NCI) |
Societe Francaise Oncologie Pediatrique |
Children's Cancer and Leukaemia Group |
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 |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Cairo MS, Gerrard M, Sposto R, Auperin A, Pinkerton CR, Michon J, Weston C, Perkins SL, Raphael M, McCarthy K, Patte C. Results of a randomized international study of high risk central nervous system B-non-Hodgkin's lymphoma and B-acute lymphoblastic leukemia in children and adolescents. Blood. 2006 Nov 30; [Epub ahead of print]
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Patte C, Auperin A, Gerrard M, Michon J, Pinkerton R, Sposto R, Weston C, Raphael M, Perkins SL, McCarthy K, Cairo MS. Results of the randomized international FAB/LMB96 trial for intermediate risk B-cell non-Hodgkin's lymphoma in children and adolescents: it is possible to reduce treatment for the early responding patients. Blood. 2006 Nov 28; [Epub ahead of print]
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Goldman S, Gerrard M, Sposto R, et al.: Excellent results in children and adolescents with isolated mature B-acute lymphoblastic leukemia (B-ALL) (Burkitt): report from the French-American-British (FAB) international LMB study FAB/LMB96. [Abstract] Blood 106 (11): A-234, 2005.
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Poirel HA, Heerema NA, Swansbury J, et al.: In pediatric mature B-cell non Hodgkin's lymphoma (NHL), complex karyotype or del(13q) are linked prognostic factors in Burkitt lymphoma (BL) while 8q24/c-myc rearrangement is associated with a strong adverse effect in diffuse large B-cell lymphoma (DLBCL). [Abstract] Blood 106 (11): A-1905, 2005.
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Lones M, Perkins S, Sposto R, et al.: T-cell-rich large B-cell lymphoma (TCRLBCL) in children and adolescents treated on a B-large cell lymphoma trial: a report from the Children's Cancer Group (CCG) study CCG-5961. [Abstract] Ann Oncol 13(suppl 2): A-137, 45, 2002.
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Perkins S, Lones M, Sposto R, et al.: B-cell non-Hodgkin lymphoma (NHL) in children and adolescents: central phenotype results from Children's Cancer Group (CCG) study CCG-5961 and implications for future targeted bio-immune therapy (TBIT). [Abstract] Ann Oncol 13(suppl 2): A-136, 45, 2002.
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Sanger W, Lones M, Perkins S, et al.: Chromosome abnormalities in B-cell non-Hodgkin lymphoma (NHL) of children and adolescents: a report from Children's Cancer Group (CCG)study CCG-5961. [Abstract] Ann Oncol 13(suppl 2): A-138, 45, 2002.
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Perkins SL, Lones MA, Cairo MS, et al.: B-cell lymphoma/leukemia in children and adolescents: central phenotype results from Children's Cancer Group study (CCG)-5961 and implications for future Targeted Bio-Immune Therapy (TBIT). [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1520, 2001.
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Lones MA, Cairo MS, Perkins SL. T-cell-rich large B-cell lymphoma in children and adolescents: a clinicopathologic report of six cases from the Children's Cancer Group Study CCG-5961. Cancer. 2000 May 15;88(10):2378-86.
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Study ID Numbers: | CDR0000064702, COG-C5961, CCG-5961, SFOP-LMB-96, CCLG-NHL-9600, EU-96048 |
First Received: | November 1, 1999 |
Last Updated: | August 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002757 |
Health Authority: | United States: Federal Government |
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