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Nilotinib vs Imatinib in Adult Patients With Philadelphia (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 titleNilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Current status of trialTerminated
Sponsors and collaboratorsNovartis Pharmaceuticals
Information provided byNovartis
ClinicalTrials.gov identifierNCT00519090
PurposeIn this study, the efficacy and safety of nilotinib 400 mg twice daily, will be compared
with imatinib 400 mg twice daily in patients with a suboptimal response to imatinib for
their Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic
phase (CML-CP).
Condition(s)Myelogenous Leukemia
Intervention(s)Drug: Imatinib
Drug: Nilotinib (AMN107)
PhasePhase III
Study type and designAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Official titleA Phase III Randomized, Open- Label Multi-center Study of Nilotinib Versus Imatinib in Adult Patients With Ph+ Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have a Suboptimal Cytogenetic Response (CyR) on Imatinib
Further study detailsThis trial was to evaluate the CCyR rate at 12 months of nilotinib therapy when compared to
imatinib treatment in patients with suboptimal response to imatinib. The patients were
stratified by prior duration of initial imatinib treatment, and were randomized to receive
either 400 mg/twice daily of continuous nilotinib or imatinib treatment. The first stratum
patients were treated with imatinib = 6 to < 12 months and having at least a minimal
cytogenetic, but no partial cytogenetic response; and the second stratum patients were
treated with imatinib = 12 months to < 18 months and having partial cytogenetic response
(PCyR), but no CCyR.
Primary outcomeComplete Cytogenetic Response Rate(CCyR) in Patients Who Had a Suboptimal Cytogenetic Response on Imatinib 12 months No Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.
Secondary outcomeDurable Complete Cytogenetic Response Rate 24 months No Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.
Study startOctober 2007
Minimum age18 Years
Maximum ageN/A
GenderBoth
Eligibility criteriaInclusion criteria:

Diagnosis of Philadelphia chromosome positive chronic myelogenous leukemia in the chronic
phase.

Patients with suboptimal cytogenetic response to a dose of 400 mg imatinib (first line
therapy) defined as:

- 6 to < 12 months of treatment and -have 36 - 95% Ph+ metaphases, or

- 12 to <18 months of treatment and have 1 - 35% Ph+ metaphases (Standard cytogenetics,
no FISH [fluorescence in situ hybridization] analysis was allowed).

Exclusion criteria:

- Patient who have received more than 18 months of imatinib therapy

- Patients who have achieved partial or complete cytogenetic response and lost that
response prior to entering the study.

- Prior treatment with greater than 400 mg/day imatinib.

- 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
LocationsArizona, United States

Arizona Cancer Center
Tucson
Arizona
85701

California, United States

Southern California Permanente Medical Group
Anaheim
California
92801

California, United States

Southern California Permanente Medical Group
Baldwin Park
California
91706

California, United States

Southern California Permanente Medical Group
Fontana
California
92334

California, United States

Kaiser Permanente Medical Group/Hayward Medical Center
Hayward
California
94540

California, United States

Southern California Permanente Medical Group
Los Angeles
California
90001

California, United States

Kaiser Permanente Medical Group/Oakland Medical Center
Oakland
California
94601

California, United States

Southern California Permanente Medical Group
Panorama City
California
91402

California, United States

Southern California Permanente Medical Group
Riverside
California
92501

California, United States

Kaiser Permanente Medical Group/South San Francisco Medical Center
S. San Francisco
California
94101

California, United States

Kaiser Permanente Medical Group/Sacramento Medical Center
Sacramento
California
94203

California, United States

Southern California Permanente Medical Group
San Diego
California
92101

California, United States

Kaiser Permanente Medical Group
San Francisco
California
94101

California, United States

Kaiser Permanente Medical Group
San Jose
California
95101

California, United States

Kaiser Permanente Medical Group/Santa Clara Medical Office
Santa Clara
California
95050

California, United States

Kaiser Permanente Medical Group/Vallejo Medical Center
Vallejo
California
94589

California, United States

Kaiser Permanente Medical Group/Walnut Creek Medical Center
Walnut Creek
California
94595

California, United States

Southen California Permanente Medical Group
Woodland Hills
California
91364

Colorado, United States

Rocky Mountain Cancer Center
Denver
Colorado
80201

Illinois, United States

Northwestern Memorial Hospital
Chicago
Illinois
60601

Illinois, United States

The University of Chicago Medical Center
Chicago
Illinois
60601

Indiana, United States

Indiana Blood and Marrow Transplantation
Beech Grove
Indiana
46107

Iowa, United States

Holden Cancer Center
Iowa City
Iowa
52240

Maryland, United States

Johns Hopkins Hospital
Baltimore
Maryland
21201

Michigan, United States

University of Michigan
Ann Arbor
Michigan
48103

Michigan, United States

Hematology Centers of Western Michigan
Grand Rapids
Michigan
49501

Nebraska, United States

Methodist Cancer Center
Omaha
Nebraska
68101

New Jersey, United States

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

North Carolina, United States

Duke University Hospital
Durham
North Carolina
27701

North Carolina, United States

Wake Forest University Health Sciences
Winston-Salem
North Carolina
27101

Oregon, United States

Oregon Health Sciences University
Portland
Oregon
97201

Pennsylvania, United States

St. Luke's Hospital and Health Network
Bethlehem
Pennsylvania
18015

Tennessee, United States

Jones Cancer Center
Germantown
Tennessee
38138

Tennessee, United States

Vanderbilt University
Nashville
Tennessee
37201

Texas, United States

University of Texas/MD Anderson Cancer Center
Houston
Texas
77001

Washington, United States

Swedish Cancer Institute
Seattle
Washington
98101

Australia

Novartis Investigative Site
Darlinghurst

Australia

Novartis Investigative Site
Herston

Australia

Novartis Investigative Site
Liverpool

Australia

Novartis Investigative Site
Perth

Australia

Novartis Investigative Site
Prahran

Australia

Novartis Investigative Site
South Brisbane

Australia

Novartis Investigative Site
St. Leonards

Belgium

Novartis Investigative Site
Brugge

Belgium

Novartis Investigative Site
Gent

Belgium

Novartis Investigative Site
Leuven

Brazil

Novartis Investigative Site
Mannheim

Brazil

Novartis Investigative Site
Porto Alegre

Brazil

Novartis Investigative Site
Sao Paulo

Czech Republic

Novartis Investigative Site
Olomouc

Czech Republic

Novartis Investigative Site
Praha

Germany

Novartis Investigative Site
Berlin

Germany

Novartis Investigative Site
Duesseldorf

Germany

Novartis Investigative Site
Eisensach

Germany

Novartis Investigative Site
Firenze

Germany

Novartis Investigative Site
Griefswald

Germany

Novartis Investigative Site
Hamburg

Germany

Novartis Investigative Site
Jena

Germany

Novartis Investigative Site
Kiel

Germany

Novartis Investigative Site
Leipzeg

Germany

Novartis Investigative Site
Postsdam

Germany

Novartis Investigative Site
Rostock

Germany

Novartis Investigative Site
Stuttgart

Germany

Novartis Investigative Site
Weiden

Italy

Novartis Investigative Site
Bologna

Italy

Novartis Investigative Site
Milano

Italy

Novartis Investigative Site
Napoli

Italy

Novartis Investigative Site
Orbassano

Italy

Novartis Investigative Site
Reggio Calabra

Italy

Novartis Investigative Site
Roma

Japan

Novartis Investigative Site
Nagoya

Japan

Novartis Investigative Site
Oaska

Japan

Novartis Investigative Site
Tokyo

Korea, Republic of

Novartis Investigative Site
Hwasun-Gun

Korea, Republic of

Novartis Investigative Site
Seoul

Spain

Novartis Investigative Site
Barcelona

Spain

Novartis Investigative Site
Madrid

Spain

Novartis Investigative Site
Salamanca

Spain

Novartis Investigative Site
Santiago de Compostela

Spain

Novartis Investigative Site
Valencia
LinksChronic Myeloid Leukemia
Study ID numbersCAMN107A2302
Last updatedNovember 4, 2011
Record first receivedAugust 17, 2007
ClinicalTrials.gov identifierNCT00519090
Download dateInformation obtained from ClinicalTrials.gov on February 23, 2012
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