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 (ENESTcmr).

CHRONIC MYELOGENOUS LEUKEMIA Clinical Trial

Official title:

An 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.

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

• CHRONIC MYELOGENOUS LEUKEMIA
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

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