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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00075725 |
RATIONALE: Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
PURPOSE: This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia.
Condition | Intervention | Phase |
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Leukemia |
Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: pegaspargase Drug: prednisone Drug: thioguanine Drug: vincristine sulfate Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | High Risk B-Precursor Acute Lymphoblastic Leukemia |
Estimated Enrollment: | 2964 |
Study Start Date: | December 2003 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients in arm I receive intrathecal cytarabine in week 1; infusions of vincristine and daunorubicin once a week in weeks 1-4; dexamethasone by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate in weeks 2 and 5 or 2-5; and an injection of pegaspargase in week 1.
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Drug: cyclophosphamide
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: cytarabine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: daunorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: dexamethasone
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: doxorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: leucovorin calcium
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: mercaptopurine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: methotrexate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: pegaspargase
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: thioguanine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: vincristine sulfate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Radiation: radiation therapy
Patients undergo radiation therapy periodically during study treatment
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Arm II: Active Comparator
Patients in arm II will receive intrathecal cytarabine in week 1; infusions of vincristine and daunorubicin once a week in weeks 1-4; dexamethasone by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate in weeks 2 and 5 or 2-5; and an injection of pegaspargase in week 1.
|
Drug: cyclophosphamide
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: cytarabine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: daunorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: dexamethasone
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: doxorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: leucovorin calcium
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: mercaptopurine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: methotrexate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: pegaspargase
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: thioguanine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: vincristine sulfate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Radiation: radiation therapy
Patients undergo radiation therapy periodically during study treatment
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Arm III: Experimental
Patients in arm III will receive cytarabine, vincristine, daunorubicin, and pegaspargase as in groups one and two. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy by infusion, injection, intrathecally, and by mouth for up to 8 weeks. |
Drug: cyclophosphamide
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: cytarabine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: daunorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: dexamethasone
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: doxorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: leucovorin calcium
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: mercaptopurine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: methotrexate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: pegaspargase
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: prednisone
Given IV or orally
Drug: thioguanine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: vincristine sulfate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Radiation: radiation therapy
Patients undergo radiation therapy periodically during study treatment
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Arm IV: Experimental
Patients in arm IV will receive cytarabine, vincristine, daunorubicin, and pegaspargase as in groups one and two. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy by infusion, injection, intrathecally, and by mouth for up to 8 weeks. |
Drug: cyclophosphamide
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: cytarabine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: daunorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: dexamethasone
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: doxorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: leucovorin calcium
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: mercaptopurine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: methotrexate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: pegaspargase
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: prednisone
Given IV or orally
Drug: thioguanine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Drug: vincristine sulfate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Radiation: radiation therapy
Patients undergo radiation therapy periodically during study treatment
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Ages Eligible for Study: | 1 Year to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Newly diagnosed B-precursor acute lymphoblastic leukemia
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Study Chair: | Eric C. Larsen, MD | Maine Children's Cancer Program at Barbara Bush Children's Hospital |
Responsible Party: | Children's Oncology Group - Group Chair Office ( Gregory H. Reaman ) |
Study ID Numbers: | CDR0000349182, COG-AALL0232 |
Study First Received: | January 9, 2004 |
Last Updated: | May 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00075725 History of Changes |
Health Authority: | Unspecified |
untreated childhood acute lymphoblastic leukemia B-cell childhood acute lymphoblastic leukemia untreated adult acute lymphoblastic leukemia B-cell adult acute lymphoblastic leukemia |
Anti-Inflammatory Agents Acute Lymphoblastic Leukemia, Childhood Dexamethasone Antimetabolites Daunorubicin Prednisone Leukemia, Lymphoid Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Leucovorin Cyclophosphamide 6-Mercaptopurine Hormones |
Anti-Bacterial Agents Leukemia Pegaspargase Vitamins Methotrexate Micronutrients Alkylating Agents Lymphoma Dexamethasone acetate Cytarabine Acute Lymphoblastic Leukemia Vitamin B Complex Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Antineoplastic Agents, Hormonal |
Anti-Inflammatory Agents Dexamethasone Prednisone Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics 6-Mercaptopurine Hormones Pegaspargase Therapeutic Uses Abortifacient Agents Methotrexate |
Dermatologic Agents Nucleic Acid Synthesis Inhibitors Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents, Hormonal Thioguanine Vincristine Abortifacient Agents, Nonsteroidal Glucocorticoids Doxorubicin Neoplasms Antineoplastic Agents, Phytogenic Antimetabolites Daunorubicin |