Phase 2
Completed N=49
Ondansetron in Preventing Nausea and Vomiting in Patients Undergoing Stem Cell Transplant
leukemia · Chronic myelomonocytic leukemia · de Novo Myelodysplastic Syndromes · Disseminated Neuroblastoma
Source: ClinicalTrials.gov NCT00795769 ↗
Enrolled (actual)
49
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates) — 23; 9; 12; 9 Participants — p=0.03
Summary
RATIONALE: Ondansetron may help lessen or prevent nausea and vomiting in patients undergoing stem cell transplant.
PURPOSE: This phase II trial is studying how well ondansetron works in preventing nausea and vomiting in patients undergoing stem cell transplant.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates) |
23; 9; 12; 9 | 0.03 sig |
Eligibility Criteria
Inclusion
- Autologous PBSC transplant patient
- English-speaking
- Planned cryopreserved PBSC infusion at the SCCA outpatient clinic
Exclusion
- History of prior autologous transplant
- Non-English-speaking
- Planned cryopreserved PBSC infusion at the UWMC inpatient unit
- Infusion of cryopreserved PBSC that are thawed and washed to remove DMSO prior to infusion
- Allergy or adverse reaction to ondansetron
Data sourced from ClinicalTrials.gov (NCT00795769). 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. Informational only — not medical advice.