TITLE:Less Intensive Therapy for Children With Non-Hodgkin's Lymphoma
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ClinicalTrials.gov Identifier: NCT00002757 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : July 24, 2014
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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 |
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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 (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 |
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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.
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Biological: filgrastim
Other Names:
Drug: cyclophosphamide Other Name: NSC-26271 Drug: doxorubicin hydrochloride Other Name: NSC-123127 Drug: prednisone Other Name: NSC-10023 Drug: vincristine sulfate Other Names:
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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.
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Biological: filgrastim
Other Names:
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:
Drug: vincristine sulfate Other Names:
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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
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Biological: filgrastim
Other Names:
Drug: cyclophosphamide Other Name: NSC-26271 Drug: cytarabine Other Name: NSC-63878 Drug: doxorubicin hydrochloride Other Name: NSC-123127 Drug: etoposide Other Names:
Drug: methotrexate Other Name: NSC-740 Drug: prednisolone Other Name: NSC-10023 Drug: therapeutic hydrocortisone Other Names:
Drug: vincristine sulfate Other Names:
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- Event Free SurvivalMinimum 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.
- Conditional SurvivalTime to death from any cause, measured from the time of randomization in Groups B and C.
- Failure Free SurvivalMinimum 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 |
DISEASE CHARACTERISTICS:
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One of the following diagnoses:
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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
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- No anaplastic large cell Ki1-positive lymphomas
- Immunophenotype and Murphy stage required prior to randomization
PATIENT CHARACTERISTICS:
Age:
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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:
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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

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