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Combination Chemotherapy Plus Steroid Therapy in Treating Children With Acute Lymphoblastic Leukemia or Lymphoblastic Non-Hodgkin's Lymphoma
This study is currently recruiting patients.
Sponsored by: | European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy plus steroid therapy is more effective for acute lymphoblastic leukemia or lymphoblastic non-Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy plus steroid therapy in treating children who have acute lymphoblastic leukemia or lymphoblastic non-Hodgkin's lymphoma.
Condition | Treatment or Intervention | Phase |
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acute undifferentiated leukemia childhood acute lymphoblastic leukemia childhood lymphoblastic lymphoma |
Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin Drug: dexamethasone Drug: doxorubicin Drug: etoposide Drug: hydrocortisone Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: methylprednisolone Drug: mitoxantrone Drug: prednisolone Drug: thioguanine Drug: vincristine Drug: vindesine Procedure: allogeneic bone marrow transplantation Procedure: biological response modifier therapy Procedure: bone marrow ablation with stem cell support Procedure: bone marrow transplantation Procedure: chemotherapy Procedure: peripheral blood stem cell transplantation |
Phase III |
MedlinePlus related topics: Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood; Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Dexamethasone Versus Prednisolone During Induction Therapy and Prolonged Versus Conventional Duration Asparaginase During Consolidation and Late Intensification Therapy in Children With Acute Lymphoblastic Leukemia or Lymphoblastic Non-Hodgkin's Lymphoma
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified for prephase therapy according to center, disease (acute lymphoblastic leukemia [ALL] vs non-Hodgkin's lymphoma [NHL]), WBC for ALL patients (less than 10,000/mm^3 vs 10,000/mm^3 to less than 100,000/mm^3 vs greater than 100,000/mm^3), stage for NHL patients (I or II vs III or IV), and whether prephase already started (yes vs no). Patients are stratified for protocol II therapy according to center, risk group (very low risk [VLR] vs average risk 1 [AR1] vs average risk 2 [AR2]), and treatment arm at first randomization.
PROJECTED ACCRUAL: A total of 1,400-1,500 patients will be accrued for this study within 5.5 years.
Eligibility
Ages Eligible for Study: up to 17 Years, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Location and Contact Information
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Publications
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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