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TITLE:Less Intensive Therapy for Children With Non-Hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.

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
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   

ChemIDplus related topics:   Doxorubicin    Doxorubicin hydrochloride    Cyclophosphamide    Filgrastim    Cytarabine    Cytarabine hydrochloride    Etoposide    Hydrocortisone    Cortisol 21-phosphate    Cortisol succinate    Hydrocortamate    Hydrocortisone 21-sodium succinate    Hydrocortisone acetate    Hydrocortisone cypionate    Hydrocortisone hemisuccinate    Proctofoam-HC    Leucovorin Calcium    Citrovorum factor    Folinic acid calcium salt pentahydrate    Leucovorin    Methotrexate    Prednisolone    6-Methylprednisolone    Depo-medrol    Medrol veriderm    Methylprednisolone    Methylprednisolone hemisuccinate    Methylprednisolone Sodium Succinate    Prednisolone acetate    Prednisolone sodium phosphate    Prednisolone Sodium Succinate    Prednisone    Vincristine sulfate    Vincristine    Etoposide phosphate    Calcium gluconate   

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   900
Study Start Date:   June 2001

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   up to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.:

      • Diffuse large cell
      • Burkitt's
      • High-grade B-cell, Burkitt's-like
    • L3 leukemia with greater than 5% blasts in bone marrow
  • No anaplastic large cell Ki1-positive lymphomas
  • Immunophenotype and Murphy stage required prior to randomization

PATIENT CHARACTERISTICS:

Age:

  • Over 6 months to under 21 years

    • Maximum age 18 years in France and the United Kingdom

Other:

  • No congenital immunodeficiency
  • No prior organ transplantation
  • No prior malignancy
  • Not HIV positive
  • Available for at least 36 months of follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Steroids initiated no more than 72 hours prior to entry allowed

    • Bone marrow and cerebrospinal fluid examination required prior to steroids

Radiotherapy:

  • Emergency radiotherapy initiated no more than 72 hours prior to entry allowed

Surgery:

  • Not specified
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002757

Locations
France
Institut Gustave Roussy    
      Villejuif, France, F-94805
United Kingdom, England
Children's Hospital - Sheffield    
      Sheffield, England, United Kingdom, S10 2TH

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Societe Francaise Oncologie Pediatrique
Children's Cancer and Leukaemia Group

Investigators
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


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
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]
 
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]
 
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.
 
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.
 
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.
 
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.
 
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.
 
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.
 
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.
 

Other Publications:

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

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Prednisone
Leukemia, Lymphoid
Hydrocortisone
Methylprednisolone
Lymphoma, small cleaved-cell, diffuse
Leucovorin
Prednisolone acetate
Cyclophosphamide
Etoposide phosphate
Small non-cleaved cell lymphoma
Lymphoma, B-Cell
Lymphoma, large-cell
Leukemia
Burkitt's lymphoma
Methotrexate
Etoposide
Lymphoma
Cytarabine
Methylprednisolone Hemisuccinate
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Cortisol succinate
Vincristine
Methylprednisolone acetate
Doxorubicin
Folic Acid
Lymphatic Diseases
B-cell lymphomas
Burkitt Lymphoma

Additional relevant MeSH terms:
Antimetabolites
Anti-Inflammatory Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Antibiotics, Antineoplastic
Hormones
Therapeutic Uses
Vitamins
Abortifacient Agents
Micronutrients
Dermatologic Agents
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Vitamin B Complex
Antineoplastic Agents, Hormonal
Immune System Diseases
Growth Substances
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Glucocorticoids

ClinicalTrials.gov processed this record on September 16, 2008




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