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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00081926 |
This study will evaluate the molecular response to high dose Gleevec in newly diagnosed patients with Chronic Myelogenous Leukemia (CML) in Chronic Phase. This study will evaluate the ability of Gleevec to reduce the amount of abnormal protein that occurs in patients with CML.
Patients who are eligible to participate will be treated for 18 months. This trial will include male or female patients 18 years or older who are newly diagnosed (within 6 months) with CML.
Condition | Intervention | Phase |
---|---|---|
Chronic Myelogenous Leukemia |
Drug: Gleevec |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Participants must meet all of the following criteria:
Exclusion Criteria:
Study ID Numbers: | CSTI571AUS177, US177, RIGHT Trial |
Study First Received: | April 26, 2004 |
Last Updated: | June 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00081926 |
Health Authority: | United States: Food and Drug Administration |
CML Chronic Myelogenous Leukemia RIGHT Trial US177 CSTI571 |
Imatinib 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 |