A Phase III Multi-center, Open-label, Randomized Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
| City: |
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Columbia |
| State: |
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Missouri |
| Zip Code: |
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65201 |
| Conditions: |
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Myelogenous Leukemia, Chronic |
| Purpose: |
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In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg
twice daily, will be compared with imatinib 400 mg once daily in newly diagnosed patients
with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic
phase (CML-CP).
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| Study Summary: |
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| Criteria: |
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Inclusion criteria:
- Chronic myelogenous leukemia in chronic phase patients within the first 6 months of
diagnosis.
- Diagnosis of chronic myelogenous leukemia in chronic phase with confirmation of
Philadelphia chromosome
Exclusion criteria:
- Treatment with a tyrosine kinase inhibitor prior to study entry is not allowed except
for no more than 2 weeks in duration of imatinib
- Any medical treatment for CML prior to study entry for longer than 2 weeks with the
exception of hydroxyurea and/or anagrelide
- Uncontrolled or significant cardiovascular disease.
- Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or
uncontrolled infection).
- Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol,
phenprocoumon)
- Currently taking certain medications that could affect the rhythm of your heart.
Other protocol-defined inclusion/exclusion criteria may apply
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| NCT ID: |
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NCT00471497 |
| Primary Contact: |
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Study Director
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Phone: +1(800)340-6843
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| Backup Contact: |
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N/A |
| Location Contact: |
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Columbia, Missouri 65201
United States
There is no listed contact information for this specific location.
Site Status: Completed |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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