Clinical trial · Interventional
Palonosetron Versus Ondansetron for the Prevention of Nausea and Vomiting
Phase II, Open, Randomized Comparative Trial of Two Different Schedules of Palonosetron Versus Ondansetron for the Prevention of Nausea and Vomiting in Patients With Hematologic Malignancies Receiving Regimens Containing High-dose Cytarabine
NCT01031498CI-TRIAL-00007769completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Chemotherapy-induced Nausea and Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ondansetron | Drug | — | UNRESOLVED |
| Palonosetron | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Ondansetron: Standard of Care
- description
- Standard of care, Ondansetron 8 mg IV as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
- interventionNames
- Drug: Ondansetron
- type
- EXPERIMENTAL
- label
- Palonosetron Group 1 (5 Days)
- description
- Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy treatment.
- interventionNames
- Drug: Palonosetron
- type
- EXPERIMENTAL
- label
- Palonosetron Group 2 (3 Days)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. 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: 1. 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. 2. Patients with ongoing emesis due to any organic etiology. 3. Patients with known hypersensitivity to the study drug or to other selective 5-HT3 receptor antagonists.
References
Publications (0)
Data not yet available
No reference posted for this study.