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

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

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)

Resource links provided by NLM:

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

Drug Information available for: Imatinib

U.S. FDA Resources

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

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Locations

United States, California
Vallejo Medical Center
Vallejo, California, United States, 94589
Hayward Medical Center
Hayward, California, United States, 94545
Dept. of Santa Clara Medical Office
Santa Clara, California, United States, 95051
Two North
San Jose, California, United States, 95119
Geary Campus
San Francisco, California, United States, 94115
South San Francisco Medical Center
San Francisco, California, United States, 94115
Oakland Medical Center
Oakland, California, United States, 94611
Southern California Permanente Medical Group
Riverside, California, United States, 92505
Walnut Creek Medical Center
Walnut Creek, California, United States, 94596
Southern California Permanente Medical Group
San Diego, California, United States, 90706
Southern California Permanente Medical Group
Baldwin Park, California, United States, 91706
Southern Permanente Medical Group
Fontana, California, United States, 92335
Southern Permanente Medical Group
Anaheim, California, United States, 92807
Southern California Permanente Medical Group
Panorama City, California, United States, 91402
Sacramento Medical Center
Sacramento, California, United States, 95825
Southern California Permanente Medical Group
Los Angeles, California, United States, 90027
Southern California Permanente Medical Group
Los Angeles, California, United States, 90027
Southern California Permanente Medical Group
Woodland Hills, California, United States, 91367
United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80909
United States, Florida
Florida Cancer Specialists
Ft. Myers, Florida, United States, 33901
Florida Cancer Institute
New Port Richey, Florida, United States, 34655
United States, Georgia
Northwest Georgia Oncology Centers
Marietta, Georgia, United States, 30060
United States, Illinois
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637-1470
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
John H. Stroger Hospital of Cook County
Chicago, Illinois, United States, 60612
United States, Indiana
Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46227
Indiana Blood and Marrow Transplantation
Beech Grove, Indiana, United States, 46107
United States, Kansas
Kansas Cancer Centers, LLC
Overland Park, Kansas, United States, 66210
United States, Michigan
Breslin Cancer Center
Lansing, Michigan, United States, 48910
Newland Medical Associates
Southfield, Michigan, United States, 48075
United States, Minnesota
Minnesota Oncology Hematology, PA
Minneapolis, Minnesota, United States, 55404
United States, Missouri
St. Joseph Oncology, Inc.
St. Joseph, Missouri, United States, 64507
Missouri Cancer Associates
Columbia, Missouri, United States, 65201
Hematology Oncology Consultants, Inc.
St. Louis, Missouri, United States, 63136
United States, New Jersey
The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10017
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Duke University Hospital
Durham, North Carolina, United States, 27707
University of North Carolina at Chapel Hill/UNC Lineberger Cancer Center
Chapel Hill, North Carolina, United States, 27599
Raleigh Hematology Oncology Associates
Raleigh, North Carolina, United States, 27607
United States, Ohio
University Hospital of Cleveland/Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Oncology Hematology Care
Cincinnati, Ohio, United States
United States, South Carolina
Hematology and Oncology Associates of S.C.
Greenville, South Carolina, United States, 29615
United States, Tennessee
Jones Cancer Center
Germantown, Tennessee, United States, 38138
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States, 37404
United States, Texas
University of Texas/MD Anderson Cancer Center
Houston, Texas, United States, 77030
Cancer Center Network of South Texas
San Antonio, Texas, United States, 78229
Texas Oncology, PA
Odessa, Texas, United States, 79761
Texas Oncology, PA
Tyler, Texas, United States, 75702
Sammons Cancer Center
Dallas, Texas, United States, 75246
United States, Utah
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84103
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
United States, Washington
Cancer Care Northwest, PS
Spokane, Washington, United States, 99202
Northwest Cancer Specialists, PC
Vancouver, Washington, United States, 98684
United Kingdom
Novartis Investigative Site
London, United Kingdom
Novartis Investigative Site
Liverpool, United Kingdom
Novartis Investigative Site
Glasgow, United Kingdom
Novartis Investigative Site
Nottingham, United Kingdom
Novartis Investigative Site
Leeds, United Kingdom

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 September 11, 2009