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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: | NCT00005596 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which regimen of chemotherapy is more effective for acute lymphoblastic leukemia.
PURPOSE: This randomized phase III trial is comparing four regimens of combination chemotherapy to see how well they work in treating children with newly diagnosed acute lymphoblastic leukemia.
Condition | Intervention | Phase |
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Leukemia |
Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: pegaspargase Drug: thioguanine Drug: vincristine sulfate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | ALinC 17: Protocol for Patients With Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia (ALL): A Phase III Study |
Study Start Date: | April 2000 |
Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study.
Consolidation (weeks 5-32): Patients are randomized to one of four treatment arms. Patients with t(1;19) are randomized to either arm III or arm IV.
Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then every 6-12 months for
1 year.
PROJECTED ACCRUAL: A total of 1,014 patients will be accrued for this study within 3.22 years.
Ages Eligible for Study: | 1 Year to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Study Chair: | Naomi J. Winick, MD | Simmons Cancer Center |
Study ID Numbers: | CDR0000067704, COG-P9905, POG-9905 |
Study First Received: | May 2, 2000 |
Last Updated: | August 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005596 History of Changes |
Health Authority: | United States: Federal Government |
untreated childhood acute lymphoblastic leukemia |
Anti-Inflammatory Agents Acute Lymphoblastic Leukemia, Childhood Dexamethasone Antimetabolites Daunorubicin 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 Thioguanine |
Dexamethasone Anti-Inflammatory Agents 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 Neoplasms Antineoplastic Agents, Phytogenic Antimetabolites Daunorubicin Leukemia, Lymphoid Immunologic Factors |