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Nilotinib Versus 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 (ENESTcmr)
This study is not yet open for participant recruitment.
Verified by Novartis, October 2008
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00760877
  Purpose

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
Chronic Myelogenous Leukemia
Drug: Nilotinib
Drug: Imatinib
Phase III

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Imatinib Imatinib mesylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • To determine 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:
  • To characterize kinetics of CMR achieved in both treatment arms [ Time Frame: 1 - 4 Years ] [ Designated as safety issue: No ]
  • To compare PFS, EFS and OS between the two arms [ Time Frame: 1 - 4 years ] [ Designated as safety issue: No ]
  • To characterize kinetics of CMR achieved after cross-over [ Time Frame: 1 - 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 192
Study Start Date: November 2008
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Nilotinib
400 mg BID
2: Active Comparator Drug: Imatinib
400 mg QD or 600 mg QD

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients ≥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:

    • LVEF < 45% or below the institutional lower limit of the normal range (whichever is higher) as determined by echocardiogram in the presence of symptoms of heart failure
    • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00760877

Contacts
Contact: Novartis 862-778-8300
Contact: Novartis +41 61 324 1111

Locations
Australia
Novartis Investigative Site
Westmead, Australia
Novartis Investigative site
Herston, Australia
Novartis Investigative Site
South Brisbane, Australia
Novartis Investigative Site
Nedlands, Australia
Novartis Investigative Site
Parkville, Australia
Novartis Investigative Site
Melbourne, Australia
Novartis Investigative Site
Adelaide, Australia
Brazil
Novartis Investigative Site
Sao Paulo, Brazil
Novartis Investigative Site
Rio de Janeiro, Brazil
Novartis Investigative Site
Curitiba, Brazil
Canada
Novartis Investigative Site
Ottawa, Canada
Novartis Investigative Site
Hamilton, Canada
Novartis Investigative Site
Halifax, Canada
Novartis Investigative Site
Sherbrooke, Canada
Novartis Investigative Site
Montreal, Canada
Sponsors and Collaborators
Novartis
  More Information

Responsible Party: Novartis ( External Affairs )
Study ID Numbers: CAMN107A2405
Study First Received: September 25, 2008
Last Updated: October 23, 2008
ClinicalTrials.gov Identifier: NCT00760877  
Health Authority: United States: Food and Drug Administration;   Australia: Department of Health and Ageing Therapeutic Goods Administration;   Brazil: Ministry of Health;   Canada: Health Canada

Keywords provided by Novartis:
CHRONIC
MYELOGENOUS
LEUKEMIA
Chronic Phase
CML

Study placed in the following topic categories:
Imatinib
Leukemia
Chronic myelogenous leukemia
Hematologic Diseases
Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009