A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) - Full Text View

A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) (ENEST)

This study is ongoing, but not recruiting participants.

First Received: May 7, 2007 Last Updated: March 27, 2009 History of Changes

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00471497

Purpose

In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, will be compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).

Condition	Intervention	Phase
Myelogenous Leukemia, Chronic	Drug: nilotinib	Phase III

MedlinePlus related topics: Bone Marrow Diseases Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Imatinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Phase III Multi-Center, Open-Label, Randomized Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Further study details as provided by Novartis:

Primary Outcome Measures:

Rate of major molecular response after 12 months of treatment assessed by the degree of elimination of the cells that carry the Bcr-Abl protein in the bone marrow.

Secondary Outcome Measures:

To compare the rate reduction in BCR-ABL transcript levels in nilotinib treatment arms with imatinib at 12 months.
To compare the rate of complete cytogenetic response (CCyR) in nilotinib treatment arms with imatinib at 12 months.

Estimated Enrollment:	771
Study Start Date:	July 2007
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion criteria

Chronic myelogenous leukemia in chronic phase patients within the first 6 months of diagnosis.
Diagnosis of chronic myelogenous leukemia in chronic phase with confirmation of Philadelphia chromosome

Exclusion criteria

Treatment with a tyrosine kinase inhibitor prior to study entry is not allowed except for no more than 2 weeks in duration of imatinib
Any medical treatment for CML prior to study entry for longer than 2 weeks with the exception of hydroxyurea and/or anagrelide
Uncontrolled or significant cardiovascular disease.
Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).
Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon)
Currently taking certain medications that could affect the rhythm of your heart.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471497

Show 62 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Chronic myeloid leukemia This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CAMN107A2303
Study First Received:	May 7, 2007
Last Updated:	March 27, 2009
ClinicalTrials.gov Identifier:	NCT00471497 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

leukemia
bone marrow
leukemia symptoms
lukemia
cml
complete blood count
lymphocyte
blood cancer
leukocytes
chronic leukemia
bone marrow biopsy
leukemia research
leukemia cells

bone marrow disease
chronic myeloid leukemia
blood cancer symptoms
white blood cell diseases
chronic myelogenous leukemia
leukemia treatment
leukemia facts
leucemia
facts about leukemia
myelogenous leukemia
bone marrow
newly diagnosed CML
newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP)

Study placed in the following topic categories:

Imatinib
Philadelphia Chromosome
Leukemia
Hematologic Neoplasms
Hematologic Diseases
Myeloproliferative Disorders

Chromosome Aberrations
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Chronic Myelogenous Leukemia
Leukemia, Myeloid
Bone Marrow Diseases

Additional relevant MeSH terms:

Philadelphia Chromosome
Leukemia
Neoplasms
Pathologic Processes
Neoplasms by Histologic Type
Hematologic Diseases

Myeloproliferative Disorders
Chromosome Aberrations
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases
Translocation, Genetic

ClinicalTrials.gov processed this record on May 07, 2009