Phase 2 N=237 Treatment

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

Leukemia

Bottom Line

View on ClinicalTrials.gov: NCT00982488 ↗

Enrolled (actual)

237

Serious AEs

32.5%

Results posted

Jan 2016

Primary outcome: Primary: Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest — 22; 0; 4; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Dasatinib (Drug); Imatinib (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: Dec 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest	22; 0; 4; 0; 0; 9	—

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.

Eligibility 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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00982488). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.