Comparing transdermal granisetron to ondansetron for nausea in stem cell transplant patients
Official title: BMT-08: A Comparative Effectiveness Study of the Efficacy and Safety of Transdermal Granisetron to Ondansetron in the Prevention of Nausea and Vomiting in Patients Undergoing Preparative Chemotherapy and Hematopoietic Stem Cell Transplantation
Run by University of Illinois Chicago · NCT04150614 · Data updated 2026-11-12
This study is testing whether a skin patch with granisetron can help reduce nausea from chemotherapy better than the standard intravenous ondansetron in patients getting stem cell transplants.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | University of Illinois Chicago Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | May 14, 2020 |
| Main results expected | March 2027 |
| Study ends | March 2028 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT04150614 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-75 receiving preparative chemotherapy for autologous or allogeneic stem cell transplants.
✕Probably not a fit
Patients with known hypersensitivity to granisetron or ondansetron, or those with a history of long QT syndrome, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of transdermal granisetron compared to intravenous ondansetron in reducing chemotherapy-induced nausea and vomiting (CINV) in patients undergoing hematopoietic stem cell transplants. It is an open-label, prospective trial that randomizes participants to receive either treatment alongside standard anti-emetic medications. Patients will self-administer the granisetron patch prior to chemotherapy, while those in the ondansetron group will receive the standard intravenous dosing. The study aims to assess the efficacy and safety of these interventions in managing CINV.
Why it matters
Potential benefit: If successful, this study could provide a more effective and convenient option for managing nausea and vomiting in patients undergoing stem cell transplants.
How similar studies have gone: Other studies have shown varying success with similar anti-emetic approaches, but this specific comparison of transdermal granisetron and ondansetron is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-75 years at time of enrollment receiving either a preparative regimen and either an autologous or allogeneic stem cell transplant. * No vomiting ≤ 24 hours prior to registration * No treatment with an antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for ≤ 30 days' prior registration or planned during protocol therapy. No patients will be removed from these treatments for study enrollment purposes. * No chronic phenothiazine administration as an antipsychotic agent (patients may receive prochlorperazine and other phenothiazines as rescue antiemetic therapy). No patients will be removed from these treatments for study enrollment purposes. * No known hypersensitivity to granisetron Exclusion Criteria: * Concurrent use of amifostine * Known hypersensitivity to granisetron patch or ondansetron * Patients with a history of long QT syndrome or Torsade de Pointes
Where it's running
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University of Illinois Cancer Center
Chicago, Illinois, United States Recruiting
Study contacts
- Principal investigator: Karen Sweiss, PharmD — University of Illinois Chicago
- Study coordinator: Karen Sweiss, PharmD
- Email: ksweis2@uic.edu
- Phone: 312-996-0875
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.