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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Societe Francaise Oncologie Pediatrique
Children's Cancer and Leukaemia Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002757
First received: November 1, 1999
Last updated: May 22, 2012
Last verified: April 2003
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: FAB LMB 96 -- TREATMENT OF MATURE B-CELL LYMPHOMA/LEUKAEMIA: A SFOP LMB 96/CCG 5961/UKCCSG NHL 9600 COOPERATIVE STUDY

Resource links provided by NLM:


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

Estimated Enrollment: 900
Study Start Date: June 2001
  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
Children's Hospital - Sheffield
Sheffield, England, United Kingdom, S10 2TH
Sponsors and Collaborators
Children's Oncology Group
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 Gustave Roussy, Cancer Campus, Grand Paris
Study Chair: Mary P. Gerrard, MBChB, FRCP, FRCPCH Children's Hospital - Sheffield
  More Information

Additional Information:
Publications:
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.

ClinicalTrials.gov Identifier: NCT00002757     History of Changes
Other Study ID Numbers: CDR0000064702, COG-C5961, CCG-5961, SFOP-LMB-96, CCLG-NHL-9600, EU-96048
Study First Received: November 1, 1999
Last Updated: May 22, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood 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

Additional relevant MeSH terms:
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Cytarabine
Methotrexate
Doxorubicin
Etoposide
Prednisolone
Methylprednisolone Hemisuccinate
Prednisone
Vincristine
Lenograstim
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Methylprednisolone acetate
Prednisolone acetate
Hydrocortisone
Methylprednisolone
Hydrocortisone-17-butyrate
Leucovorin
Levoleucovorin
Prednisolone hemisuccinate

ClinicalTrials.gov processed this record on April 16, 2014