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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Dasatinib; Imatinib Mesylate

Criteria

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)