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Nilotinib Versus Standard Imatinib (400/600 mg QD) Comparing the Kinetics of Complete Molecular Response for CML-CP Pts With Evidence of Persistent Leukemia by RQ-PCR
Link to the ClinicalTrials.gov recordInformation obtained from ClinicalTrials.gov on February 23, 2012
Title of trial/grant titleNilotinib Versus Standard Imatinib (400/600 mg QD) Comparing the Kinetics of Complete Molecular Response for CML-CP Pts With Evidence of Persistent Leukemia by RQ-PCR
Current status of trialActive, not recruiting
Sponsors and collaboratorsNovartis Pharmaceuticals
Information provided byNovartis
ClinicalTrials.gov identifierNCT00760877
PurposeThe primary goal of this study is to determine the rate of confirmed best cumulative
complete molecular response within the first year of study therapy with imatinib or
nilotinib. The study will also explore the impact and significance of the achieved CMR on
patient outcomes (PFS, EFS and OS), characterize the kinetics of CMR achieved in both
treatment arms and after the cross-over.
Condition(s)CHRONIC MYELOGENOUS LEUKEMIA
Intervention(s)Drug: Nilotinib
Drug: Imatinib
PhasePhase III
Study type and designAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Official titleAn Open Label, Randomized Study of Nilotinib vs. Standard Imatinib (400/600 mg QD) Comparing the Kinetics of Complete Molecular Response for CML-CP Patients With Evidence of Persistent Leukemia by RQ-PCR
Primary outcomeTo determine rate of confirmed best cumulative CMR within the first year of study therapy with imatinib or nilotinib 12 months of treatment No
Secondary outcomeTo characterize kinetics of CMR achieved in both treatment arms 1 - 4 Years No
To compare PFS, EFS and OS between the two arms 1 - 4 years No
To characterize kinetics of CMR achieved after cross-over 1 - 4 years No
Study startJune 2009
Minimum age18 Years
Maximum ageN/A
GenderBoth
Eligibility criteriaInclusion Criteria:

- Patients â¿¥18 years old

- Diagnosis of chronic myeloid leukemia associated with BCR-ABL quantifiable by
RQ-PCR

- Documented CCyR by bone marrow or BCR-ABL<1% IS in the past 12 months

- Persistent disease demonstrated by two PCR positive tests 3 months apart both during
the past 6 months.

- Treatment with imatinib for at least 2 years with 400 mg or 600 mg and a stable dose

- No other current or planned anti-leukemia therapies

Exclusion Criteria:

- Patient has evidence of rising PCR (a confirmed >1 log increase in previous 6 months)

- Patient has received another investigational agent within last 6 months or 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 ECG

- Long QT syndrome or a known family history of long QT syndrome.

- Clinically significant resting brachycardia (<50 beats per minute)

- QTc > 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
Study chairs or principal investigatorsNovartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals
LocationsArgentina

Novartis Investigative site
Buenos Aires

Australia

Novartis Investigative Site
Adelaide

Australia

Novartis Investigative site
Herston

Australia

Novartis Investigative Site
Melbourne

Australia

Novartis Investigative Site
Nedlands

Australia

Novartis Investigative Site
Parkville

Australia

Novartis Investigative Site
South Brisbane

Australia

Novartis Investigative Site
St. Leonards

Australia

Novartis Investigative Site
Westmead

Australia

Novartis Investigative Site
Woolloongabba

Brazil

Novartis Investigative Site
Belo Horizonte

Brazil

Novartis Investigative Site
Campinas

Brazil

Novartis Investigative Site
Curitiba

Brazil

Novartis Investigative Site
Rio de Janeiro

Brazil

Novartis Investigative Site
Sao Paulo

British Columbia, Canada

Novartis Investigative Site
Vancouver
British Columbia
V5Z 1M9

Ontario, Canada

Novartis Investigative Site
Hamilton
Ontario
L8N 3Z5

Ontario, Canada

Novartis Investigative Site
Toronto
Ontario
M5G 2M9

Quebec, Canada

Novartis Investigative Site
Montreal
Quebec
H1T 2M4

Quebec, Canada

Novartis Investigative Site
Quebec City
Quebec
G1J 1Z4

France

Novartis Investigative Site
Bordeaux

France

Novartis Investigative Site
Creteil

France

Novartis Investigative Site
Lyon

France

Novartis Investigative Site
Paris

France

Novartis Investigative Site
Vandoeuvre-Les-Nancy

Spain

Novartis Investigative Site
Barcelona

Spain

Novartis Investigative Site
Madrid

Spain

Novartis Investigative Site
Malaga

Spain

Novartis Investigative Site
Pamplona
31008
Study ID numbersCAMN107A2405; EudraCT 2009-012616-40
Last updatedFebruary 7, 2011
Record first receivedSeptember 25, 2008
ClinicalTrials.gov identifierNCT00760877
Download dateInformation obtained from ClinicalTrials.gov on February 23, 2012
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