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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) Eastern Cooperative Oncology Group Southwest Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00558519 |
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating young 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: mercaptopurine Drug: methotrexate Drug: pegaspargase Drug: thioguanine Drug: vincristine sulfate Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | An Intergroup Phase II Clinical Trial for Adolescents and Young Adults With Untreated Acute Lymphoblastic Leukemia (ALL) |
Estimated Enrollment: | 300 |
Study Start Date: | October 2007 |
Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 16 Years to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Newly diagnosed acute lymphoblastic leukemia (ALL)
Enrollment on CALGB-C10001 (or its successor trial) for CALGB patients with Philadelphia-positive ALL take priority over enrollment on this protocol
Patients enrolled on this study but are later found to meet the following criteria for Ph+ ALL eligibility criteria for protocol CALGB-C10001 (or its successor trial) are removed from this study and enrolled on CALGB-C10001 (or its successor study):
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study Chair: | Richard A. Larson, MD | University of Chicago |
Investigator: | John C. Grecula, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Study Chair: | Selina M. Luger, MD | University of Pennsylvania |
Study Chair: | Anjali Advani, MD | The Cleveland Clinic |
Study ID Numbers: | CDR0000574230, CALGB-10403, ECOG C10403, SWOG C10403 |
Study First Received: | November 14, 2007 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00558519 |
Health Authority: | Unspecified |
B-cell adult acute lymphoblastic leukemia T-cell adult acute lymphoblastic leukemia untreated adult acute lymphoblastic leukemia |
Dexamethasone Daunorubicin Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Thioguanine Vincristine Cyclophosphamide 6-Mercaptopurine Doxorubicin |
Acute lymphoblastic leukemia, adult Folic Acid Pegaspargase Leukemia Lymphatic Diseases Methotrexate Lymphoproliferative Disorders Lymphoma Cytarabine Dexamethasone acetate |
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 Therapeutic Uses Abortifacient Agents |
Dermatologic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Mitosis Modulators Gastrointestinal Agents Enzyme Inhibitors Antimitotic Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Glucocorticoids Immunosuppressive Agents Antiviral Agents |