Phase 2
N=150
Palonosetron Versus Ondansetron for the Prevention of Nausea and Vomiting
Acute Myelogenous Leukemia · Chemotherapy-induced Nausea and Vomiting
Bottom Line
View on ClinicalTrials.gov: NCT01031498 ↗Enrolled (actual)
150
Serious AEs
8.0%
Results posted
Feb 2011
Primary outcome: Primary: Number of Patients With Complete Response — 11; 15; 18 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ondansetron (Drug); Palonosetron (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Complete Response |
11; 15; 18 | — |
Summary
The goal of this clinical research study is to compare the effectiveness of 3 drug schedules in preventing chemotherapy-related nausea and/or vomiting in patients with acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (MDS).
Eligibility Criteria
Inclusion Criteria
- Patients > 18 years with acute myelogenous leukemia or high-risk myelodysplastic syndrome undergoing chemotherapy with high dose cytarabine (1.5 or 2gm/m^2) containing regimens.
- 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 nausea (oral intake is significantly decreased) or 3 nausea (no significant intake requiring intravenous fluids)</= 24 hours before chemotherapy.
- Patients with ongoing emesis due to any organic etiology.
- Patients with known hypersensitivity to the study drug or to other selective 5-HT3 receptor antagonists.
Data sourced from ClinicalTrials.gov (NCT01031498). 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.