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Sponsors and Collaborators: |
European Organization for Research and Treatment of Cancer Leucemies Aigues et Lymphomes de l'Adulte |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002700 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. Bone marrow transplantation can replace immune cells that were destroyed by chemotherapy.
PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy compared with or without bone marrow transplantation in treating patients with acute lymphoblastic leukemia.
Condition | Intervention | Phase |
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Leukemia Lymphoma |
Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: mitoxantrone hydrochloride Drug: prednisolone Drug: prednisone Drug: therapeutic hydrocortisone Drug: vincristine sulfate Procedure: allogeneic bone marrow transplantation Procedure: autologous bone marrow transplantation Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A RANDOMIZED PHASE III TRIAL COMPARING DEXAMETHASONE WITH PREDNISONE IN INDUCTION TREATMENT AND BONE MARROW TRANSPLANTATION WITH INTENSIVE MAINTENANCE TREATMENT IN ADOLESCENT AND ADULT ACUTE LYMPHOBLASTIC LEUKEMIA (ALL-4) |
Ages Eligible for Study: | 15 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Roel Willemze, MD, PhD | Leiden University Medical Center |
Study Chair: | Denis Fiere, MD | Leucemies Aigues et Lymphomes de l'Adulte |
Study ID Numbers: | CDR0000064498, EORTC-06951, FRE-LALA-94 |
Study First Received: | November 1, 1999 |
Last Updated: | August 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002700 |
Health Authority: | United States: Federal Government |
untreated adult acute lymphoblastic leukemia stage I adult lymphoblastic lymphoma stage III adult lymphoblastic lymphoma |
stage IV adult lymphoblastic lymphoma contiguous stage II adult lymphoblastic lymphoma noncontiguous stage II adult lymphoblastic lymphoma |
Dexamethasone Daunorubicin Prednisone Leukemia, Lymphoid Hydrocortisone Methylprednisolone Leucovorin Prednisolone acetate Cyclophosphamide 6-Mercaptopurine Acute lymphoblastic leukemia, adult Leukemia Methotrexate Lymphoma Dexamethasone acetate |
Cytarabine Methylprednisolone Hemisuccinate Asparaginase Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Cortisol succinate Methylprednisolone acetate Vincristine Lymphoblastic lymphoma Doxorubicin Folic Acid Calcium, Dietary Lymphatic Diseases Prednisolone Mitoxantrone |
Anti-Inflammatory Agents Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Reproductive Control Agents Antibiotics, Antineoplastic Hormones Sensory System Agents Vitamins |
Therapeutic Uses Abortifacient Agents Analgesics Micronutrients Dermatologic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors Vitamin B Complex Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Growth Substances Mitosis Modulators Gastrointestinal Agents Enzyme Inhibitors |