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)
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5801 South Ellis Avenue
Chicago, Illinois 60637
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291 Campus Dr
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12902 USF Magnolia Dr
Tampa, Florida 33612
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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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Houston, Texas 77030
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Indianapolis, Indiana 46227
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4800 Friendship Ave
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