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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00760877
Other study ID # CAMN107A2405
Secondary ID 2009-012616-40
Status Completed
Phase Phase 3
First received September 25, 2008
Last updated March 10, 2016
Start date June 2009
Est. completion date July 2015

Study information

Verified date March 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods AdministrationBrazil: Ministry of HealthCanada: Health Canada
Study type Interventional

Clinical Trial Summary

The 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.


Recruitment information / eligibility

Status Completed
Enrollment 206
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Other protocol-defined inclusion/exclusion criteria may apply Other protocol related

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Nilotinib

Imatinib
400 mg QD or 600 mg QD

Locations

Country Name City State
Argentina Novartis Investigative Site Caba Buenos Aires
Australia Novartis Investigative Site Adelaide South Australia
Australia Novartis Investigative Site Herston Queensland
Australia Novartis Investigative Site Nedlands Western Australia
Australia Novartis Investigative Site Parkville Victoria
Australia Novartis Investigative Site Prahran Victoria
Australia Novartis Investigative Site South Brisbane Queensland
Australia Novartis Investigative Site St. Leonards New South Wales
Australia Novartis Investigative Site Westmead New South Wales
Australia Novartis Investigative Site Woolloongabba Queensland
Brazil Novartis Investigative Site Belo Horizonte MG
Brazil Novartis Investigative Site Campinas SP
Brazil Novartis Investigative Site Curitiba PR
Brazil Novartis Investigative Site Rio de Janeiro RJ
Brazil Novartis Investigative Site Sao Paulo SP
Canada Novartis Investigative Site Hamilton Ontario
Canada Novartis Investigative Site Montreal Quebec
Canada Novartis Investigative Site Québec Quebec
Canada Novartis Investigative Site Toronto Ontario
Canada Novartis Investigative Site Vancouver British Columbia
France Novartis Investigative Site Bordeaux
France Novartis Investigative Site Creteil
France Novartis Investigative Site Lyon cedex 04
France Novartis Investigative Site Paris
France Novartis Investigative Site Vandoeuvre les Nancy
Spain Novartis Investigative Site Barcelona Cataluña
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Malaga Andalucia
Spain Novartis Investigative Site Pamplona Navarra

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Argentina,  Australia,  Brazil,  Canada,  France,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of confirmed best cumulative CMR within the first year of study therapy with imatinib or nilotinib 12 months of treatment No
Secondary kinetics of CMR achieved in both treatment arms 1 - 4 years No
Secondary Progression free survival, EFS and OS between the two arms 1 4 years No
Secondary Kinetics of CMR achieved after cross-over 1 - 4 years No
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