Phase 3
Completed N=421
Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients
Source: ClinicalTrials.gov NCT01254188 ↗Enrolled (actual)
421
Serious AEs
23.0%
Results posted
Mar 2016
Primary outcomePrimary: The Percentage of Patients Achieving MMR by 12 Months — 70.8 percentage of participants
Summary
This study will further investigate the safety and efficacy of nilotinib in newly diagnosed chronic myeloid leukemia patients in the chronic phase
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Patients Achieving MMR by 12 Months |
70.8 | — |
| SECONDARY Time to Molecular Response at 24 Months |
6.0 | — |
| SECONDARY Duration of Major Molecular Response |
100; 97.1; 92.8; 92.1; 91.7; 90.8 | — |
| SECONDARY Complete Cytogenetic Response |
58.7 | — |
| SECONDARY Percentage of Participants Estimated to Maintain Their First CCyR for 6, 12, 18, and 24 Months After the First CCyR Was Achieved as Determined by Kaplan Meier Estimatation. |
100; 99.6; 98.7; 98.7 | — |
| SECONDARY Overall Survival |
99.8; 99.5; 99.5; 99.0; 98.2; 97.6 | — |
| SECONDARY Kaplan-Meier Estimates of Progression-free Survival |
99.7; 99.5; 98.9; 98.6; 98.0; 97.6 | — |
| SECONDARY Kaplan-Meier Estimates of Failure-free Survival |
97.4; 95.9; 94.6; 93.6; 92.0; 91.0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01254188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.