Phase 2
N=98
Ondansetron Versus Aprepitant Plus Ondansetron for Emesis
Hematologic Diseases · Acute Myelogenous Leukemia · Myelodysplastic Syndrome · Chronic Myelogenous Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00954941 ↗Enrolled (actual)
98
Serious AEs
6.7%
Results posted
Jan 2014
Primary outcome: Primary: Participant Responses — 20; 21; 9; 12 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ondansetron (Drug); Aprepitant (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant Responses |
20; 21; 9; 12; 13; 8 | — |
| PRIMARY Treatment Success Rate |
48; 51 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00954941). 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.