CompletedPhase 2

Ondansetron Versus Aprepitant Plus Ondansetron for Emesis

United States100 participantsStarted 2009-11

Plain-language 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 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Participant Responses

Timeframe: First 6 treatment days

Treatment Success Rate

Timeframe: First 6 treatment days

Trial details

NCT IDNCT00954941

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-04

Results submitted2013-11-26

View on ClinicalTrials.gov More Hematologic Diseases trials