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A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Link to the ClinicalTrials.gov recordInformation obtained from ClinicalTrials.gov on February 23, 2012
Title of trial/grant titleA Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Current status of trialActive, not recruiting
Sponsors and collaboratorsNovartis Pharmaceuticals
Information provided byNovartis
ClinicalTrials.gov identifierNCT00471497
PurposeIn 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(s)Myelogenous Leukemia, Chronic
Intervention(s)Drug: nilotinib
Drug: imatinib
PhasePhase III
Study type and designAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Official titleA 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)
Primary outcomeTo compare the rate of major molecular response (MMR)as measured by real-time quantitative polymerase chain reaction (RQ-PCR) at 12 months. 12 months No
Secondary outcomeTo compare the rate of durable MMR at 24 months. 24 months No
To compare the rate reduction in BCR-ABL transcript levels in nilotinib treatment arms with imatinib at 12 months. 12 months No
To compare the rate of complete cytogenetic response (CCyR) in nilotinib treatment arms with imatinib at 12 months. 12 months No
Study startJuly 2007
Minimum age18 Years
Maximum ageN/A
GenderBoth
Eligibility criteriaInclusion 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
Study chairs or principal investigatorsNovartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals
LocationsCalifornia, United States

Southern Permanente Medical Group
Anaheim
California
92807

California, United States

Southern California Permanente Medical Group
Baldwin Park
California
91706

California, United States

Southern Permanente Medical Group
Fontana
California
92335

California, United States

Hayward Medical Center
Hayward
California
94545

California, United States

Southern California Permanente Medical Group
Los Angeles
California
90027

California, United States

University of California Los Angeles
Los Angeles
California
90095

California, United States

Oakland Medical Center
Oakland
California
94611

California, United States

Southern California Permanente Medical Group
Panorama City
California
91402

California, United States

Southern California Permanente Medical Group
Riverside
California
92505

California, United States

Sacramento Medical Center
Sacramento
California
95825

California, United States

Southern California Permanente Medical Group
San Diego
California
90706

California, United States

Geary Campus
San Francisco
California
94115

California, United States

South San Francisco Medical Center
San Francisco
California
94115

California, United States

Two North
San Jose
California
95119

California, United States

Dept. of Santa Clara Medical Office
Santa Clara
California
95051

California, United States

Vallejo Medical Center
Vallejo
California
94589

California, United States

Walnut Creek Medical Center
Walnut Creek
California
94596

California, United States

Southern California Permanente Medical Group
Woodland Hills
California
91367

Colorado, United States

Rocky Mountain Cancer Center
Denver
Colorado
80909

Florida, United States

Florida Cancer Specialists
Ft. Myers
Florida
33901

Florida, United States

Florida Cancer Institute
New Port Richey
Florida
34655

Georgia, United States

Northwest Georgia Oncology Centers
Marietta
Georgia
30060

Illinois, United States

The University of Chicago Medical Center
Chicago
Illinois
60637-1470

Illinois, United States

Northwestern Memorial Hospital
Chicago
Illinois
60611

Illinois, United States

John H. Stroger Hospital of Cook County
Chicago
Illinois
60612

Indiana, United States

Indiana Blood and Marrow Transplantation
Beech Grove
Indiana
46107

Indiana, United States

Central Indiana Cancer Centers
Indianapolis
Indiana
46227

Iowa, United States

University of Iowa
Iowa City
Iowa
52242

Kansas, United States

Kansas Cancer Centers, LLC
Overland Park
Kansas
66210

Michigan, United States

Breslin Cancer Center
Lansing
Michigan
48910

Michigan, United States

Newland Medical Associates
Southfield
Michigan
48075

Minnesota, United States

Minnesota Oncology Hematology, PA
Minneapolis
Minnesota
55404

Missouri, United States

Missouri Cancer Associates
Columbia
Missouri
65201

Missouri, United States

St. Joseph Oncology, Inc.
St. Joseph
Missouri
64507

Missouri, United States

Hematology Oncology Consultants, Inc.
St. Louis
Missouri
63136

New Jersey, United States

The Cancer Center at Hackensack University Medical Center
Hackensack
New Jersey
07601

New York, United States

Roswell Park Cancer Institute
Buffalo
New York
14263

New York, United States

Memorial Sloan-Kettering Cancer Center
New York
New York
10017

North Carolina, United States

University of North Carolina at Chapel Hill/UNC Lineberger Cancer Center
Chapel Hill
North Carolina
27599

North Carolina, United States

Duke University Hospital
Durham
North Carolina
27707

North Carolina, United States

Raleigh Hematology Oncology Associates
Raleigh
North Carolina
27607

North Carolina, United States

Wake Forest University Health Sciences
Winston-Salem
North Carolina
27157

Ohio, United States

Oncology Hematology Care
Cincinnati
Ohio
45238-4279

Ohio, United States

University Hospital of Cleveland/Case Comprehensive Cancer Center
Cleveland
Ohio
44106

Ohio, United States

Cleveland Clinic Foundation Taussig Cancer Center
Cleveland
Ohio
44195

South Carolina, United States

Hematology and Oncology Associates of S.C.
Greenville
South Carolina
29615

Tennessee, United States

Chattanooga Oncology Hematology Associates
Chattanooga
Tennessee
37404

Tennessee, United States

Jones Cancer Center
Germantown
Tennessee
38138

Tennessee, United States

Tennessee Oncology
Nashville
Tennessee
37203

Texas, United States

Sammons Cancer Center
Dallas
Texas
75246

Texas, United States

University of Texas/MD Anderson Cancer Center
Houston
Texas
77030

Texas, United States

Texas Oncology, PA
Odessa
Texas
79761

Texas, United States

Cancer Center Network of South Texas
San Antonio
Texas
78229

Texas, United States

Texas Oncology, PA
Tyler
Texas
75702

Utah, United States

Utah Cancer Specialists
Salt Lake City
Utah
84103

Virginia, United States

University of Virginia Cancer Center
Charlottesville
Virginia
22908

Washington, United States

Cancer Care Northwest, PS
Spokane
Washington
99202

Washington, United States

Northwest Cancer Specialists, PC
Vancouver
Washington
98684

United Kingdom

Novartis Investigative Site
Glasgow

United Kingdom

Novartis Investigative Site
Leeds

United Kingdom

Novartis Investigative Site
Liverpool

United Kingdom

Novartis Investigative Site
London

United Kingdom

Novartis Investigative Site
Nottingham
LinksVisit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.
Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.
Study ID numbersCAMN107A2303; EUDRACT 2007-000208-34
Last updatedMay 27, 2010
Record first receivedMay 7, 2007
ClinicalTrials.gov identifierNCT00471497
Download dateInformation obtained from ClinicalTrials.gov on February 23, 2012
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