BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron

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

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.

Study Overview

• Status: Recruiting
• Conditions: Nausea With Vomiting Chemotherapy-Induced
• Intervention / Treatment: Drug: Granisetron Transdermal Patch; Drug: Intravenous Dexamethasone; Drug: Ondansetron

Detailed Description

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. This study will be an open-label, prospective trial randomizing patients at a 1:1 ratio, to either one of two 5-hydroxytrytamine 3 (5-HT3) antagonists, transdermal granisetron or intravenous (i.v.) ondansetron, in combination with other standard, routinely administered anti-emetic drugs (dexamethasone). Rescue antiemetics will be administered at any time during the study period for vomiting or severe nausea at the request of the patients or as recommended by the attending physicians. For the granisetron treatment arm, patients will be educated and instructed to self-administer a single transdermal granisetron patch one-two days (approximately 24-48 hours) prior to start of the preparative regimen. An additional dose of transdermal granisetron will be administered 7 days after the initial granisetron dose. For the ondansetron treatment arm, patients will receive the standard dose and schedule of intravenous ondansetron that is routinely administered for each respective preparative regimen. Use of rescue medications will be assessed daily during chemotherapy, and for 7 days after the last chemotherapy drug administration (delayed phase). Nausea, vomiting, and treatment-related side effects will be documented and followed during this same time period. A quality of life questionnaire (MDASI-BMT) will be administered at Day + 7 (7 days after day of infusion). All other aspects of patient care (i.e., chemotherapy administration, supportive care, etc.) and laboratory monitoring will adhere to the routine standard of care operating procedures for stem cell transplant patients.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Karen Sweiss, PharmD; Phone Number: 312-996-0875; Email: ksweis2@uic.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois Cancer Center
      • Contact: Karen Sweiss, PharmD; Phone Number: 312-996-0875; Email: ksweis2@uic.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1; ARM 1 -transdermal granisetron plus intravenous dexamethasone	Drug: Granisetron Transdermal Patch; Antiemetic; Drug: Intravenous Dexamethasone; Antiemetic
Active Comparator: ARM 2; ARM 2 -intravenous ondansetron plus intravenous dexamethasone	Drug: Intravenous Dexamethasone; Antiemetic; Drug: Ondansetron; ondansetron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0 hours to 24 hours post-chemotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours to 120 hours post-chemotherapy
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.	24 hours to 120 hours post-chemotherapy
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	Up to 7 days after the preparative regimen
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	Up to 21 - 37 days post-HSCT
To compare the occurrence of treatment-related adverse events (AE) between patients receiving transdermal Granisetron versus intravenous Ondansetron.	Treatment-related adverse events (AE) will be evaluated using NCI CTCAE version 5.	Up to 21 - 37 days post-HSCT
To compare quality of life throughout the course of HSCT between patients receiving transdermal Granisetron versus intravenous Ondansetron.	The M.D. Anderson Symptom Inventory (MDASI) Core Items-Bone Marrow Transplant (BMT) scale will be utilized to measure quality of life at baseline, on the day of stem cell infusion, 7 days after stem cell infusion, and 21-37 days post-stem cell infusion	Up to 21-37 days post-HSC

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Investigators: Principal Investigator: Karen Sweiss, PharmD, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2020
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): November 12, 2025
• Last Update Submitted That Met QC Criteria: November 7, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Hematopoietic Stem Cell Transplantation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Imidazoles; Indoles; Heterocyclic Compounds, 3-Ring; Carbazoles; Ondansetron
• Other Study ID Numbers: 2019-0886

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes