Phase 2 N=49 Supportive Care

Ondansetron in Preventing Nausea and Vomiting in Patients Undergoing Stem Cell Transplant

Accelerated Phase Chronic Myelogenous Leukemia · Adult Acute Lymphoblastic Leukemia in Remission · Adult Acute Myeloid Leukemia in Remission · Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities · Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)

Bottom Line

View on ClinicalTrials.gov: NCT00795769 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2017

Primary outcome: Primary: Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates) — 23; 9; 12; 9 Participants — p=0.03

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ondansetron (Drug); survey administration (Other); management of therapy complications (Procedure)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Fred Hutchinson Cancer Center
Primary completion: Jun 2009

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

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.

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

View full record on ClinicalTrials.gov →

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.