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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Granisetron Transdermal Patch
DrugAntiemetic
Intravenous Dexamethasone
DrugAntiemetic
Ondansetron
Drugondansetron
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Arm 1Active comparator 2 interventions
Group B: ARM 2Active comparator 2 interventions
Trial outcomes
Primary outcomes
1
To compare between the two study arms the number of patients achieving complete response (no vomiting and no use of rescue medications) during the acute period (0-24 hours post-chemotherapy) for patients receiving preparative chemotherapy and HSCT.
Efficacy of Ondansetron and Dexamethasone versus Transdermal Granisetron and Dexamethasone in preventing chemotherapy induced nausea and vomiting during the acute period (0 - 24 hours post-chemotherapy) for patients receiving preparative chemotherapy and HSCT.
Time frame
0 hours to 24 hours post-chemotherapySecondary outcomes
1
To compare between the two study arms the number of patients achieving complete response (no vomiting and no use of rescue medications) during the delayed period (24-120 hours post-chemotherapy) for patients receiving preparative chemotherapy and HSCT.
Efficacy of Ondansetron and Dexamethasone versus Transdermal Granisetron and Dexamethasone in preventing chemotherapy induced nausea and vomiting during the delayed period (24-120 hours post-chemotherapy) for patients receiving preparative chemotherapy and HSCT.
Time frame
24 hours to 120 hours post-chemotherapy2
To compare between the two study arms the number of patients achieving complete response (no vomiting and no use of rescue medications) during the overall period (24-120 hours post-chemotherapy) for patients receiving preparative chemotherapy and HSCT.
Efficacy of Ondansetron and Dexamethasone versus Transdermal Granisetron and Dexamethasone in preventing chemotherapy induced nausea and vomiting during the overall period (24-120 hours post-chemotherapy) for patients receiving preparative chemotherapy and HSCT.
Time frame
24 hours to 120 hours post-chemotherapy3
To compare between the two study arms, the use of rescue anti-emetic medications (during and for 7 days after the preparative regimen) for patients receiving preparative chemotherapy and HSCT.
Comparing the use of rescue anti-emetic medications between the two arms during and up to 7 days after the preparative regimen
Time frame
Up to 7 days after the preparative regimen4
To compare between the two study arms the occurrence of CINV complete protection for patients receiving preparative chemotherapy and HSCT.
Complete protection is defined as no emetic episode, no use of rescue medications and no nausea, during the acute, delayed, and overall phases
Time frame
Up to 21 - 37 days post-HSCTSponsors and contacts
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Source ClinicalTrials.gov