CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib



Status:Completed
Conditions:Other Indications, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology, Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2010
End Date:November 2014

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A Single-arm, Open-label, Multi-center Study of Complete Molecular Response (CMR) in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

"This is a single-arm, open-label, multi-center study of complete molecular response (CMR)
in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic
myelogenous leukemia in chronic phase (CML-CP). The study is designed to evaluate early and
deep molecular responses up to 4 years on nilotinib treatment. The primary end point is Rate
of confirmed CMR in newly diagnosed Philadelphia chromosome positive CML-CP patients."


Inclusion Criteria:

Patients with Ph+ CML-CP within 3 months of diagnosis. Male or female patients' ≥ 18 years
of age. Patients must have adequate end organ function.

Exclusion Criteria:

Previously documented T315I mutation. Other CML treatment is an exclusion criteria with
the following exception: While awaiting study start, patients may be treated with
anagrelide (no treatment duration limit), hydroxyurea (no treatment duration limit),
and/or up to a 14 day supply of a tyrosine kinase inhibitor (TKI) approved by the FDA for
frontline treatment. Patients taking a TKI prior to study entry must have at least a one
day washout from their last dose of medication and have recovered from any side effects of
such therapy.

Impaired cardiac function as defined by the protocol. Patients with contraindications to
receiving nilotinib, including concomitant medications.
We found this trial at
32
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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8940 N Kendall Dr # 300E
Miami, Florida 33176
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Anaheim, California 92801
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Augusta, GA
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Beach Grove, Indiana 46107
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Beach Grove, IN
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Burbank, CA
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Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Chattanooga, TN
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Chicago, Illinois 60640
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Concord, CA
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Durham, NC
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1717 13th St
Everett, Washington 98201
(425) 297-5500
Providence Regional Cancer Partnership Founded in 2007, the Providence Regional Cancer Partnership is the result...
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Everett, WA
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Germantown, Tennessee 38138
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Greenville, South Carolina 29605
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Houston, Texas 77090
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Jacksonville, Florida 32256
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New Port Richey, Florida 34652
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Witchita, Kansas 67214
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Yorba Linda, CA
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