Status:
COMPLETED
A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Myelogenous Leukemia, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, were compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia ch...
Detailed Description
Primary objectives of this study: * Compared the efficacy (major molecular response (MMR) rate at 12 months) of nilotinib at 400 mg bid with that of imatinib 400 mg qd in newly diagnosed, previously ...
Eligibility Criteria
Inclusion
- Key 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 of (9:22) translocations
- Key Exclusion criteria:
- Previously documented T315I mutation
- 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
- Impaired cardiac function.
- Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).
- Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon)
- Currently receiving treatment with any medications that have the potential to prolong the QT interval.
Exclusion
Key Trial Info
Start Date :
July 31 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 21 2019
Estimated Enrollment :
846 Patients enrolled
Trial Details
Trial ID
NCT00471497
Start Date
July 31 2007
End Date
August 21 2019
Last Update
November 18 2020
Active Locations (213)
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1
University of California at Los Angeles Dept. of Hematology Clinic
Los Angeles, California, United States, 90095
2
Kaiser Permanente - California Southern Dept of Kaiser South 3
San Diego, California, United States, 92120
3
Kaiser Permanente - California Northern Vallejo Med Center/Med Offices
Vallejo, California, United States, 94589
4
Kaiser Permanente - California Northern Kaiser Med
Vallejo, California, United States, 94609