Study on Imatinib Mesylate or Dasatinib for Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT00070499
This clinical trial is comparing two medications, Imatinib Mesylate and Dasatinib, to see how well they work in treating patients with newly diagnosed chronic phase chronic myelogenous leukemia (CML). These drugs may help stop cancer cell growth by blocking certain enzymes needed for cell growth.
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Program Overview
The purpose of this study is to compare the effectiveness of two drugs, Imatinib Mesylate and Dasatinib, in treating patients with chronic phase chronic myelogenous leukemia (CML) who have not received any prior treatment. The study will look at how well these drugs reduce cancer markers in the blood after 12 months of treatment. It will also explore if a higher dose of Imatinib Mesylate is more effective and assess the safety and side effects of these treatments.
Description
This study involves three groups of patients, each receiving a different treatment:
- Group 1: Patients take Imatinib Mesylate once a day for up to 5 years, as long as the disease does not worsen or side effects are manageable.
- Group 2: Patients take a higher dose of Imatinib Mesylate twice a day for up to 12 months, as long as the disease does not worsen or side effects are manageable.
- Group 3: Patients take Dasatinib twice a day for up to 5 years, as long as the disease does not worsen or side effects are manageable.
The study will measure how well these treatments reduce cancer markers in the blood, their impact on survival, and any side effects. Patients will be followed for 15 years after completing the treatment to monitor long-term outcomes.
Eligibility Criteria
Inclusion Criteria
- Must have chronic phase chronic myelogenous leukemia (CML) confirmed by specific tests.
- Must join the study within 180 days of being diagnosed with CML.
- Must have a performance status score of 0-2, indicating good overall health.
- Must not have received any prior treatment for CML, except for certain medications like hydroxyurea.
- Must have normal liver function and blood test results within specified limits.
- Must not have had major surgery within 28 days before joining the study.
- Must not be pregnant or nursing and must agree to use effective birth control.
- Must not have any other active cancer, except for certain types that have been treated and are in remission.
- Must have a recent electrocardiogram (ECG) and no serious heart conditions.
- Must not have a history of significant bleeding disorders.
- Must agree to participate and sign an informed consent form.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Providence Saint Joseph Medical Center/Disney Family Cancer Center | 91505 | Burbank | California |
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| Kaiser Permanente-Fremont | 94538 | Fremont | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| Kaiser Permanente-Oakland | 94611 | Oakland | California |
| Kaiser Permanente-Redwood City | 94063 | Redwood City | California |
| Kaiser Permanente-Richmond | 94801 | Richmond | California |
| Kaiser Permanente-Roseville | 95661 | Roseville | California |
| Kaiser Permanente-South Sacramento | 95823 | Sacramento | California |
| Kaiser Permanente Sacramento Medical Center | 95825 | Sacramento | California |
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