TITLE:Less Intensive Therapy for Children With Non-Hodgkin's Lymphoma
Leukemia, Lymphoma
About this trial
This is an interventional treatment trial for Leukemia focused on measuring 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
Eligibility 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
Sites / Locations
- Institut Gustave Roussy
- Children's Hospital - Sheffield
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Group A
Group B
Group C
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.
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.
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