Ondansetron Versus Aprepitant Plus Ondansetron for Emesis
Completed · Phase 2
Conditions studied: Hematologic Diseases, Acute Myelogenous Leukemia, Myelodysplastic Syndrome, Chronic Myelogenous Leukemia
In brief
The goal of this clinical research study is to compare the effectiveness of receiving a combination of ondansetron and aprepitant to receiving ondansetron alone in helping to prevent nausea and/or vomiting in patients with Acute myeloid leukemia (AML) or high-risk (HR) Myelodysplastic syndromes (MDS) who are receiving cytarabine. The safety of this drug combination will also be studied.
Key facts
- Study ID
- NCT00954941
- Run by
- M.D. Anderson Cancer Center
- People needed
- 100
- Starts
- 2009-11-01
- Expected to finish
- 2015-05-01
- Last updated by the study team
- 2015-06-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients greater than or equal to 18 years of age.
- Patients with a diagnosis of acute myelogenous leukemia, high-risk myelodysplastic syndrome, chronic myelogenous leukemia in blast crisis or acute undifferentiated leukemia who will receive chemotherapy with regimens containing high-dose cytarabine (greater or equal 1g/m\^2/d for at least 3 days).
- Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
You may not qualify if…
- Patients with emesis or grade 2 or 3 nausea present less than or equal to 24 hours before chemotherapy.
- Patients with ongoing emesis due to any organic etiology
- Patients with known hypersensitivity to the study drug or to 5-HT3 receptor antagonists
- Patients receiving pimozide, terfenadine, astemizole, or cisapride
Where it is running
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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