Status:
COMPLETED
Ondansetron Versus Aprepitant Plus Ondansetron for Emesis
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Hematologic Diseases
Acute Myelogenous Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 vom...
Detailed Description
Cytarabine is a drug that is used to treat AML and high-risk MDS. It is known to cause nausea and/or vomiting. All patients that receive cytarabine also receive drugs to help prevent these side effect...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00954941
Start Date
November 1 2009
End Date
May 1 2015
Last Update
June 25 2015
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030