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Long-term Safety of Dasatinib in Patients With Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Not Recruiting
Trial ID: NCT00982488
Purpose
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.
Official Title
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
Eligibility
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)
Intervention(s):
drug: Dasatinib
drug: Imatinib
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Dana Supan
6507258538