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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Novartis |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00038610 |
The goal of this clinical research study is to learn if intensive chemotherapy, combined with imatinib mesylate (Gleevec, STI571) given for 8 courses over 6 months, followed by maintenance imatinib mesylate plus chemotherapy for 2 years, followed by imatinib mesylate indefinitely can improve Philadelphia-positive acute lymphoblastic leukemia. The safety of this treatment will also be studied.
Condition | Intervention | Phase |
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Leukemia, Lymphocytic, Acute, L2 |
Drug: Imatinib Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Dexamethasone Drug: Methotrexate Drug: Cytarabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Hyper-CVAD Plus Imatinib Mesylate (Gleevec, STI571) for Philadelphia-Positive Acute Lymphocytic Leukemia |
Enrollment: | 54 |
Study Start Date: | March 2001 |
Estimated Study Completion Date: | July 2015 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Hyper-CVAD + Imatinib
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Drug: Imatinib
Imatinib 600mg PO
Drug: Cyclophosphamide
Cyclophosphamide 300mg/m2
Drug: Doxorubicin
Doxorubicin 50mg/m2
Drug: Vincristine
Vincristine 2mg
Drug: Dexamethasone
Dexamethasone 40mg
Drug: Methotrexate
Methotrexate 200mg/m2
Drug: Cytarabine
Cytarabine 3gm/m2
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Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Susan O'Brien, M.D. | M.D. Anderson Cancer Center |
Responsible Party: | University of Texas - MD Anderson Cancer Center ( Susan O'Brien, MD, BA, Professor ) |
Study ID Numbers: | ID01-006 |
Study First Received: | June 3, 2002 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00038610 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Leukemia, Lymphoblastic, Acute, Philadelphia-Positive |
Anti-Inflammatory Agents Dexamethasone Antimetabolites Leukemia, Lymphoid Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Cyclophosphamide Protein Kinase Inhibitors Hormones Anti-Bacterial Agents Leukemia Hyperkinesis Methotrexate |
Lymphoma Alkylating Agents Dexamethasone acetate Cytarabine Acute Lymphoblastic Leukemia Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Antineoplastic Agents, Hormonal Vincristine Antimitotic Agents Folic Acid Antagonists Glucocorticoids Immunosuppressive Agents Antiviral Agents Doxorubicin |
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 Protein Kinase Inhibitors Hormones Therapeutic Uses Abortifacient Agents Methotrexate Dermatologic Agents Nucleic Acid Synthesis Inhibitors |
Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents, Hormonal Vincristine Abortifacient Agents, Nonsteroidal Glucocorticoids Doxorubicin Imatinib Neoplasms Antineoplastic Agents, Phytogenic Antimetabolites Leukemia, Lymphoid Immunologic Factors Antineoplastic Agents |