BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Illinois at Chicago
About this trial
Patients undergoing either an autologous or allogeneic hematopoietic stem cell transplant (HSCT) and receiving preparative chemotherapy experience a considerable amount of chemotherapy-induced nausea and vomiting (CINV). Current strategies at reducing CINV in this patient population are suboptimal due to lack of efficacy and supportive evidence, potential for increased adverse events, and drug-drug and drug-disease contraindications.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Concurrent use of amifostine
Known hypersensitivity to granisetron patch or ondansetron
Patients with a history of long QT syndrome or Torsade de Pointes
Trial design
Treatments tested in this trial
- Granisetron Transdermal Patch
- Intravenous Dexamethasone
- Ondansetron
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov