Status:
COMPLETED
Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will further investigate the safety and efficacy of nilotinib in newly diagnosed chronic myeloid leukemia patients in the chronic phase
Eligibility Criteria
Inclusion
- Patients with chronic myeloid leukemia in the chronic phase diagnosed within 6 months of study entry
Exclusion
- Treatment with tyrosine kinase inhibitor or other antileukemic agents or treatments (including HSCT) for longer than 2 weeks, with exception of hydroxyurea and/or anagrelide
- Uncontrolled congestive heart failure or hypertension
- Myocardial infarction or unstable angina pectoris within past 12 months
- Known T315I mutations
- QTcF \>450 msec
- Significant arrhythmias
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
421 Patients enrolled
Trial Details
Trial ID
NCT01254188
Start Date
April 1 2011
End Date
November 1 2014
Last Update
March 3 2016
Active Locations (100)
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1
Novartis Investigative Site
Algiers, Bouzareah, Algeria, 16000
2
Novartis Investigative Site
Oran, Algeria, 31000
3
Novartis Investigative Site
Buenos Aires, Buenos Aires, Argentina, C1114AAN
4
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1221ADC