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

This study has been completed.
Sponsor:
Collaborators:
Societe Francaise Oncologie Pediatrique
Children's Cancer and Leukaemia Group
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00002757
First received: November 1, 1999
Last updated: July 23, 2014
Last verified: July 2014
  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: cyclophosphamide
Drug: cytarabine
Drug: doxorubicin hydrochloride
Drug: etoposide
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/Leukemia: A SFOP LMB 96/CCG 5961/UKCCSG NHL 9600 Cooperative Study

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Event Free Survival [ Designated as safety issue: No ]
    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:
  • Conditional Survival [ Designated as safety issue: No ]
    Time to death from any cause, measured from the time of randomization in Groups B and C.

  • Failure Free Survival [ Designated as safety issue: No ]
    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.


Enrollment: 1148
Study Start Date: June 2001
Study Completion Date: October 2009
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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.

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00002757     History of Changes
Other Study ID Numbers: 5961, COG-C5961, CCG-5961, SFOP-LMB-96, CCLG-NHL-9600, EU-96048, CDR0000064702
Study First Received: November 1, 1999
Last Updated: July 23, 2014
Health Authority: United States: Federal Government

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:
Leukemia
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cortisol succinate
Cyclophosphamide
Doxorubicin
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone-17-butyrate
Liposomal doxorubicin
Methotrexate
Vincristine
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents

ClinicalTrials.gov processed this record on October 21, 2014