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).

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: September 25, 2008
Last updated: March 10, 2016
Last verified: March 2016
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.

Condition Intervention Phase
Drug: Nilotinib
Drug: Imatinib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Rate of confirmed best cumulative CMR within the first year of study therapy with imatinib or nilotinib [ Time Frame: 12 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • kinetics of CMR achieved in both treatment arms [ Time Frame: 1 - 4 years ] [ Designated as safety issue: No ]
  • Progression free survival, EFS and OS between the two arms [ Time Frame: 1 4 years ] [ Designated as safety issue: No ]
  • Kinetics of CMR achieved after cross-over [ Time Frame: 1 - 4 years ] [ Designated as safety issue: No ]

Enrollment: 206
Study Start Date: June 2009
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Nilotinib
Active Comparator: B Drug: Imatinib
400 mg QD or 600 mg QD
Other Name: Tasigna


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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Please refer to this study by its identifier: NCT00760877

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Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00760877     History of Changes
Other Study ID Numbers: CAMN107A2405  2009-012616-40 
Study First Received: September 25, 2008
Last Updated: March 10, 2016
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Brazil: Ministry of Health
Canada: Health Canada

Keywords provided by Novartis:
Chronic Phase

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on July 24, 2016