Actively Recruiting
BMT-08: Comparing Transdermal Granisetron and Intravenous Ondansetron for Preventing Nausea and Vomiting in Patients Undergoing Preparative Chemotherapy and Stem Cell Transplantation
Led by University of Illinois at Chicago · Updated on 2025-11-12
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients undergoing autologous or allogeneic hematopoietic stem cell transplant (HSCT) often receive preparative chemotherapy that causes significant chemotherapy-induced nausea and vomiting (CINV). Current treatments to reduce CINV in these patients are not fully effective and may cause side effects or have drug interactions. This study compares two anti-nausea medications to find out which works better and is safer for these patients. The study randomly assigns patients to one of two groups: one group uses a transdermal granisetron patch applied one to two days before chemotherapy and again seven days later, combined with intravenous dexamethasone; the other group receives intravenous ondansetron with intravenous dexamethasone following standard dosing schedules. Rescue anti-nausea medications can be used as needed during chemotherapy and for seven days afterward. Patient care, chemotherapy, and lab monitoring follow usual procedures throughout the study. Participants will be monitored daily for nausea, vomiting, and side effects during chemotherapy and for a week after. A quality of life questionnaire (MDASI-BMT) is completed seven days after the transplant infusion. Researchers will compare how many patients avoid vomiting and rescue medication use during several timeframes, assess side effects, and evaluate quality of life up to about a month after transplant. The study runs until July 2026 and follows patients closely to understand the treatments' effects.
CONDITIONS
Brief Title
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years at time of enrollment
- Receiving preparative chemotherapy regimen and either autologous or allogeneic stem cell transplant
- No vomiting within 24 hours prior to registration
- Not treated with antipsychotic agents such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone within 30 days prior or planned during study
- No chronic phenothiazine use as antipsychotic (rescue antiemetic use allowed)
- No known allergy to granisetron
You will not qualify if you...
- Concurrent use of amifostine
- Known allergy to granisetron patch or ondansetron
- History of long QT syndrome or Torsade de Pointes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to approximately 2 weeks including chemotherapy and 7 days after last chemotherapy dose
Participants receive either a transdermal granisetron patch or intravenous ondansetron along with intravenous dexamethasone to prevent nausea and vomiting during preparative chemotherapy and stem cell transplantation. The transdermal granisetron patch is applied 1 to 2 days prior to chemotherapy and reapplied 7 days later, while intravenous ondansetron is administered according to the standard schedule for the chemotherapy regimen.
Daily visits during chemotherapy and for 7 days after chemotherapy
Duration - Up to 21 to 37 days post-transplant
Participants are monitored for nausea, vomiting, treatment-related side effects, and quality of life up to about 21 to 37 days after stem cell transplantation.
1 visit at Day +7 post-infusion and additional monitoring visits as needed
Trial Site Locations
Total: 1 location
1
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612
Actively Recruiting
Research Team
K
Karen Sweiss, PharmD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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