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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00324636 |
RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for their growth. It is not yet known which dose of imatinib mesylate is more effective in treating chronic myelogenous leukemia.
PURPOSE: This randomized phase III trial is studying two different doses of imatinib mesylate to compare how well they work in treating patients with newly diagnosed chronic phase chronic myelogenous leukemia.
Condition | Intervention | Phase |
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Leukemia |
Drug: imatinib mesylate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | A Randomized Open-Label Study of 400 mg Versus 800 mg of Gleevec/Glivec (Imatinib Mesylate) in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Using Molecular Endpoints |
Estimated Enrollment: | 420 |
Study Start Date: | January 2006 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive oral imatinib mesylate twice daily.
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Drug: imatinib mesylate
Given orally
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Arm II: Active Comparator
Patients receive oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity. Patients with unresponsive disease after 3-12 months of treatment may receive imatinib mesylate twice daily.
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Drug: imatinib mesylate
Given orally
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to the Sokal relative risk score (< 0.8 [low-risk] vs 0.8-1.2 [intermediate risk] vs > 1.2 [high-risk]). Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline, every 3 months during study treatment, and at 6 and 12 months after completion of study treatment.
After completion of study treatment, patients are followed every 3 months for up to 5 years.
PROJECTED ACCRUAL: A total of 420 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Cytogenetically confirmed chronic myelogenous leukemia in chronic phase (CML-CP)
Chronic phase is defined by all of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No other concurrent anticancer agents, including chemotherapy or biologic agents
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | |
Los Angeles, California, United States, 90095-1781 |
Study Chair: | Ronald Paquette, MD | Jonsson Comprehensive Cancer Center |
Responsible Party: | Novartis Pharmaceuticals Corporation ( Alan K. Hatfield ) |
Study ID Numbers: | CDR0000480338, UCLA-0511009-01, NOVARTIS-CSTI571K2301, EUDRACT-2005-00657-29, FWA00004642 |
Study First Received: | May 10, 2006 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00324636 |
Health Authority: | United States: Federal Government |
Philadelphia chromosome positive chronic myelogenous leukemia chronic phase chronic myelogenous leukemia |
Imatinib Philadelphia Chromosome Leukemia Chronic myelogenous leukemia Hematologic Diseases |
Myeloproliferative Disorders Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase Leukemia, Myeloid Bone Marrow Diseases |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |