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
Recruitment status was Active, not recruiting
Sponsor:
Children's Oncology Group
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
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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:
Drug Information available for:
Hydrocortisone acetate
Cyclophosphamide
Hydrocortisone
Prednisolone
Prednisolone acetate
Prednisone
Methylprednisolone acetate
Methotrexate
Methylprednisolone
Prednisolone sodium phosphate
Hydrocortisone sodium succinate
Cytarabine
Prednisolone phosphate
Hydrocortisone cypionate
Leucovorin calcium
Prednisolone sodium succinate
Vincristine sulfate
Methylprednisolone sodium succinate
Hydrocortisone butyrate
Methotrexate sodium
Doxorubicin
Doxorubicin hydrochloride
Etoposide
Hydrocortisone valerate
Levoleucovorin
Hydrocortisone probutate
Etoposide phosphate
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
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 | Institut Gustave Roussy |
| 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 May 19, 2013