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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00061945 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as alemtuzumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of alemtuzumab and to see how well it works when given together with combination chemotherapy in patients with previously untreated acute lymphoblastic leukemia.
Condition | Intervention | Phase |
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Leukemia |
Biological: alemtuzumab Biological: filgrastim Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: imatinib mesylate Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: vincristine sulfate |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Dose Escalation Study of Subcutaneous Campath-1H (NSC #715969, IND #10864) During Intensification Therapy in Adults With Untreated Acute Lymphoblastic Leukemia (ALL) |
Estimated Enrollment: | 282 |
Study Start Date: | June 2003 |
Estimated Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No prior treatment for leukemia except for any of the following:
Must have a pretreatment bone marrow or peripheral blood sample submitted for central immunophenotyping
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
No concurrent palliative radiotherapy
Surgery
Other
Study Chair: | Wendy Stock, MD | University of Chicago |
Study ID Numbers: | CDR0000302482, CALGB-10102 |
Study First Received: | June 5, 2003 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00061945 History of Changes |
Health Authority: | United States: Food and Drug Administration |
B-cell adult acute lymphoblastic leukemia L1 adult acute lymphoblastic leukemia L2 adult acute lymphoblastic leukemia |
T-cell adult acute lymphoblastic leukemia untreated adult acute lymphoblastic leukemia acute undifferentiated leukemia |
Anti-Inflammatory Agents Dexamethasone Antimetabolites Daunorubicin Leukemia, Lymphoid Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Leucovorin 6-Mercaptopurine Cyclophosphamide Protein Kinase Inhibitors Hormones Anti-Bacterial Agents |
Leukemia Vitamins Alemtuzumab Methotrexate Micronutrients Alkylating Agents Lymphoma Dexamethasone acetate Cytarabine Acute Lymphoblastic Leukemia Asparaginase Vitamin B Complex Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Antineoplastic Agents, Hormonal |
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 Protein Kinase Inhibitors Hormones Alemtuzumab Therapeutic Uses Abortifacient Agents Methotrexate |
Dermatologic Agents Nucleic Acid Synthesis Inhibitors Asparaginase Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents, Hormonal Vincristine Abortifacient Agents, Nonsteroidal Glucocorticoids Imatinib Neoplasms Antineoplastic Agents, Phytogenic Antimetabolites Daunorubicin |