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

NCT04150614 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2019-0886
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nausea With Vomiting Chemotherapy-Induced

Keywords

Hematopoietic Stem Cell Transplantation

Outcome Measures

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.

  0 hours to 24 hours post-chemotherapy

Secondary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  Up to 21 - 37 days post-HSCT

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

ARM 1 -transdermal granisetron plus intravenous dexamethasone

Drug: Granisetron Transdermal Patch; Drug: Intravenous Dexamethasone

ARM 2

ACTIVE COMPARATOR

ARM 2 -intravenous ondansetron plus intravenous dexamethasone

Drug: Intravenous Dexamethasone; Drug: Ondansetron

Interventions

Granisetron Transdermal Patch DRUG

Antiemetic

Arm 1

Intravenous Dexamethasone DRUG

Antiemetic

ARM 2; Arm 1

Ondansetron DRUG

ondansetron

ARM 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Concurrent use of amifostine
• Known hypersensitivity to granisetron patch or ondansetron
• Patients with a history of long QT syndrome or Torsade de Pointes

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois Cancer Center

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Interventions

Ondansetron

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Karen Sweiss, PharmD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Sweiss, PharmD

CONTACT

312-996-0875; ksweis2@uic.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Randomized 1:1 to either Arm 1 transdermal granisetron OR Arm 2 intravenous ondansetron

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 5, 2019
• Study Start: May 14, 2020
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 12, 2025

Record last verified: 2025-11

Locations

US (1)