Extending Molecular Responses With Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) Patients in Chronic Phase
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Chronic Myeloid Leukemia
Both
Chronic Myeloid Leukemia
Trial Information
Extending Molecular Responses With Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) Patients in Chronic Phase
Inclusion Criteria:
-Patients with chronic myeloid leukemia in the chronic phase diagnosed within 6 months of
study entry
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Major Molecular Response
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CAMN107E2401
NCT ID:
NCT01254188
Start Date:
April 2011
Completion Date:
September 2014
Related Keywords:
- Chronic Myeloid Leukemia
- Chronic myeloid leukemia,
- CML,
- nilotinib,
- myelogenous,
- Philadelphia chromosome
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
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