Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
Prevention of DMSO-Related Nausea and Vomiting by Prophylactic Administration of Ondansetron for Patients Receiving Autologous Cryopreserved Peripheral Blood Stem Cells
| Verified date | August 2010 |
| Source | Fred Hutchinson Cancer Research Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Federal Government |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | |
| Est. primary completion date | September 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 21 Years and older |
| Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| United States | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Fred Hutchinson Cancer Research Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Reduction in rates of nausea or vomiting after ondansetron (compared to historical rates) | With stem cell infusion | No |
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