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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00002757
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 24, 2014
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Societe Francaise Oncologie Pediatrique
Children's Cancer and Leukaemia Group
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

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 or disease Intervention/treatment Phase
Leukemia Lymphoma Biological: filgrastim Drug: cyclophosphamide Drug: cytarabine Drug: doxorubicin hydrochloride Drug: etoposide Drug: methotrexate Drug: prednisolone Drug: prednisone Drug: therapeutic hydrocortisone Drug: vincristine sulfate Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1148 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: FAB LMB 96 -- Treatment of Mature B-CELL Lymphoma/Leukemia: A SFOP LMB 96/CCG 5961/UKCCSG NHL 9600 Cooperative Study
Study Start Date : June 2001
Actual Primary Completion Date : October 2003
Actual Study Completion Date : October 2009


Arm Intervention/treatment
Active Comparator: Group A
All resected stage I and Abdominal stage II only. All Group A patients will be treated with two cycles of COPAD and will be followed in a confirmatory study of the current result of nearly 100% cure rate.
Biological: filgrastim
Other Names:
  • G-CSF
  • Neupogen
  • NSC-614629

Drug: cyclophosphamide
Other Name: NSC-26271

Drug: doxorubicin hydrochloride
Other Name: NSC-123127

Drug: prednisone
Other Name: NSC-10023

Drug: vincristine sulfate
Other Names:
  • VCR
  • NSC-675574

Active Comparator: Group B
Non resected stage I & II, stage III & st IV (CNS - ve, BM < 25%). Patients with bulky disease are at risk from metabolic complications secondary to tumor lysis syndrome. Vigorous measures should be taken to minimise the risk of this. Prior to any chemotherapy being administered intravenous hydration fluids should be given run at a rate of 3000 mls/m2/day. Alkalinisation may be necessary Pay close attention to fluid balance and continue hydration fluids after the administration of COP for as long as the risk of tumour lysis persists.
Biological: filgrastim
Other Names:
  • G-CSF
  • Neupogen
  • NSC-614629

Drug: cyclophosphamide
Other Name: NSC-26271

Drug: doxorubicin hydrochloride
Other Name: NSC-123127

Drug: methotrexate
Other Name: NSC-740

Drug: prednisolone
Other Name: NSC-10023

Drug: prednisone
Other Name: NSC-10023

Drug: therapeutic hydrocortisone
Other Names:
  • HYDROCORTISONE SODIUM SUCCINATE
  • NSC-10483

Drug: vincristine sulfate
Other Names:
  • VCR
  • NSC-675574

Active Comparator: Group C
Bone marrow > 25% but CNS negative Patients with bulky disease are at risk from metabolic complications secondary to tumor lysis syndrome. Vigorous measures should be taken to minimize the risk of this. Intravenous hydration fluids should be given prior to chemotherapy. Alkalinisation may be necessary. Monitor fluid balance and continue hydration fluids after the administration of COP for as long as the risk of tumor lysis persists
Biological: filgrastim
Other Names:
  • G-CSF
  • Neupogen
  • NSC-614629

Drug: cyclophosphamide
Other Name: NSC-26271

Drug: cytarabine
Other Name: NSC-63878

Drug: doxorubicin hydrochloride
Other Name: NSC-123127

Drug: etoposide
Other Names:
  • VP16
  • NSC-141540

Drug: methotrexate
Other Name: NSC-740

Drug: prednisolone
Other Name: NSC-10023

Drug: therapeutic hydrocortisone
Other Names:
  • HYDROCORTISONE SODIUM SUCCINATE
  • NSC-10483

Drug: vincristine sulfate
Other Names:
  • VCR
  • NSC-675574




Primary Outcome Measures :
  1. Event Free Survival
    Minimum time to death from any cause, relapse, or progressive disease, measured from the beginning of chemotherapy. Failure to respond to initial COP therapy, and biopsy positive residual disease at the third evaluation are not considered failures in this definition. However, death, relapse or disease progression following protocol mandated therapy intensification after these occurrences will be considered failures. In addition, biopsy positive residual disease at the completion of intensification is considered an event.


Secondary Outcome Measures :
  1. Conditional Survival
    Time to death from any cause, measured from the time of randomization in Groups B and C.

  2. Failure Free Survival
    Minimum time to death from any cause, progressive disease before the third evaluation, no CR at the third evaluation, relapse after the third evaluation, measured from the beginning of chemotherapy. Failure to respond to COP therapy in Groups B and C is not considered a treatment failure, but biopsy positive residual disease after the third evaluation are considered failures in this definition.



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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002757


Locations
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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
National Cancer Institute (NCI)
Societe Francaise Oncologie Pediatrique
Children's Cancer and Leukaemia Group
Investigators
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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
Publications of Results:
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.

Other Publications:
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00002757    
Other Study ID Numbers: 5961
COG-C5961 ( Other Identifier: Children's Oncology Group )
CCG-5961 ( Other Identifier: Children's Cancer Group )
SFOP-LMB-96
CCLG-NHL-9600
EU-96048
CDR0000064702 ( Other Identifier: Clinical Trials.gov )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 24, 2014
Last Verified: July 2014
Keywords provided by Children's Oncology Group:
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:
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Lymphoma
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Prednisone
Prednisolone
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Methotrexate
Etoposide
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists