A Phase 2 interventional study of ondansetron and survey administration in Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission and Adult Acute Myeloid Leukemia in Remission, sponsored by Fred Hutchinson Cancer Center. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2017-05-23.
Sponsored by Fred Hutchinson Cancer Center · Phase 2, Interventional, and Supportive care
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.
OBJECTIVES:
I. To determine whether the incidence of nausea and vomiting related to administration of autologous hematopoetic stem cells cryopreserved in DMSO can be reduced by the use of a single dose of intravenous ondansetron prior to the stem cell infusion.
II. To determine the number of patients who experience nausea and vomiting.
OUTLINE: Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.
392 studies on the registry are indexed under Burkitt Lymphoma; 114 are open to participants now.
This study's enrollment of 49 is above the median of 41 across 354 interventional studies indexed under Burkitt Lymphoma.
Browse Burkitt Lymphoma studies →Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion
Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.
Drug: ondansetron · Other: survey administration · Procedure: management of therapy complications
Given IV
Also known as: GR 38032F, GR-C507/75, Zofran
Correlative studies
Ondansetron IV
Also known as: complications of therapy, management of
Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates)
Nausea Multinational Association of Supportive Care in Cancer Antiemesis Tool™ (MAT). Increased MAT scores represent worse outcome (score 0-10). Vomiting represented as present or absent.
Time frame: Baseline up to 120 minutes
| Milestone | Ondansetron Therapy |
|---|---|
| Started | 49 |
| Completed | 49 |
| Not completed | 0 |
Nausea Multinational Association of Supportive Care in Cancer Antiemesis Tool™ (MAT). Increased MAT scores represent worse outcome (score 0-10). Vomiting represented as present or absent.
| Participants | Ondansetron Therapy |
|---|---|
| MAT score >2 on arrival and pre-ondansetron | 23 |
| Baseline MAT score >2 prior to first ASCT infusion | 9 |
| MAT score increases >2 by end of infusion | 12 |
| Number of patients that vomited | 9 |
Collected over 11 months between August 2008-June 2009. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ondansteron Therapy | 0/49 (0%) | 0/49 (0%) | 18/49 (36.7%) |
| Event | Ondansteron Therapy |
|---|---|
| nauseaGastrointestinal disorders | 9/49 |
| vomitingGastrointestinal disorders | 6/49 |
| nausea and vomitingGastrointestinal disorders | 3/49 |
| Age, Categorical(Participants) | Ondansteron Therapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 43 |
| >=65 years | 6 |
| Age, Continuous(years) | Ondansteron Therapy |
|---|---|
| Median | 52 (27 to 67) |
| Sex: Female, Male(Participants) | Ondansteron Therapy |
|---|---|
| Female | 20 |
| Male | 29 |
| Region of Enrollment(participants) | Ondansteron Therapy |
|---|---|
| United States | 49 |
Plan to share: No
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Fred Hutchinson Cancer Center