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Phase 3 N=207 Randomized Treatment

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

Enrolled (actual)
207
Serious AEs
18.0%
Results posted
Aug 2016
Primary outcome: Primary: Rate of Confirmed Best Cumulative Complete Molecular Response (CMR) — 13; 6; 91; 97 Participants — p=0.1083

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

OutcomeResultp-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

The primary goal of this study was to determine the rate of confirmed best cumulative complete molecular response (CMR) within the first year of study therapy with imatinib or nilotinib. The study also explored the impact and significance of the achieved CMR on patient outcomes (progression free survival (PFS), event free survival (EFS) and overall survival (OS), characterized the kinetics of CMR achieved in both treatment arms and after the cross-over.

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

View full record on ClinicalTrials.gov →

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.

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