Nilotinib Versus Standard Imatinib (400/600 mg Every Day (QD)) Comparing the Kinetics of Complete Molecular Response for Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Pts With Evidence of Persistent Leukemia by Real-time Quantitative Polymerase Chain Reaction (RQ-PCR)
CHRONIC MYELOGENOUS LEUKEMIA
Bottom Line
View on ClinicalTrials.gov: NCT00760877 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nilotinib (Drug); Imatinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Confirmed Best Cumulative Complete Molecular Response (CMR) |
13; 6; 91; 97 | 0.1083 |
| SECONDARY Rate of Confirmed Best Cumulative CMR |
24; 11; 80; 92; 29; 21 | — |
| SECONDARY Number of Cross-over Participants With CMR |
3; 6; 9 | — |
| SECONDARY Progression Free Survival (PFS) |
NA; NA | — |
| SECONDARY Event-free Survival |
NA; NA | — |
| SECONDARY Overall Survival |
NA; NA | — |
Summary
Eligibility Criteria
Inclusion Criteria
Diagnosis of chronic myeloid leukemia associated with BCR-ABL quantifiable by RQ-PCR Documented CCyR by bone marrow or BCR-ABL 1 log increase in previous 6 months) Patient has received another investigational agent within last 6 months or tyrosine kinase inhibitors (TKIs) other than imatinib Prior allogeneic stem cell transplantation
Impaired cardiac function including any one of the following:
Inability to monitor the QT interval on electrocardiogram (ECG) Long QT syndrome or a known family history of long QT syndrome. Clinically significant resting brachycardia ( 450 msec on baseline ECG (using the QTcF formula). If QTcF >450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc Myocardial infarction within 12 months prior to starting study Other clinically significant uncontrolled heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension) History of or presence of clinically significant ventricular or atrial tachyarrhythmias Administration of cytokine therapy (e.g. G-CSF, GM-CSF or SCF) within 4 weeks prior to study entry
Data sourced from ClinicalTrials.gov (NCT00760877). 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.