Long-term Safety of Dasatinib in Patients With Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia



Status:Completed
Conditions:Other Indications, Blood Cancer, Blood Cancer, Hematology, Leukemia
Therapuetic Areas:Hematology, Oncology, Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2007
End Date:December 2014

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Dasatinib in Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects Who Are Experiencing Clinical Benefit on Current START or CA180-039 Protocols: Long Term Safety and Efficacy Analysis

This study assesses the long-term safety and tolerability of dasatinib administered to
patients with chronic myelogenous leukemia or Philadelphia chromosome positive acute
lymphoblastic leukemia and experienced clinical benefit from treatment with dasatinib or
imatinib in previous protocols.


Key Inclusion Criteria

- Signed written informed consent

- Received treatment in protocols CA180-005, CA180-006, CA180-013, CA180-015 or
CA180-017, or CA180-039

- Received clinical benefit with dasatinib or imatinib (study CA180017) in the opinion
of the Investigator

- Men and women, ages 18 and older

Key Exclusion Criteria

- A serious uncontrolled medical disorder or active infection that would impair the
ability of the patient to receive protocol therapy

- Dementia or altered mental status that would prohibit the understanding or rendering
of informed consent

- Patients currently taking drugs, including but not limited to quinidine,
procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide,
erythromycins, clarithromycin, chlorpromazine, haloperidol, mesoridazine,
thioridazine, pimozide, ziprasidone, cisapride, bepridil, droperidol, methadone,
arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine,
sparfloxacin, and lidoflazine, which are generally accepted to have a risk of causing
Torsades de Pointes

- Patients taking medications known to be potent CYP3A4 inhibitors (ketoconazole,
ritonavir) or inducers (rifampin, efavirenz)
We found this trial at
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Boston, Massachusetts 02115
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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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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291 Campus Dr
Stanford, California 94305
(650) 725-3900
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Vallejo, California 94589
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Anaheim, California 92801
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Ann Arbor, Michigan 48109
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Capital Federal, Buenos Aires
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Hackensack, New Jersey 07601
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Indianapolis, Indiana 46227
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Loma Linda, California 92354
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Los Angeles, California 90095
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4800 Friendship Ave
Pittsburgh, Pennsylvania 15224
(412) 578-5000
Western Pennsylvania Hospital Featuring 308 private patient beds, West Penn Hospital has served Bloomfield and...
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Westwood, Kansas 66205
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