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

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.

Conditions

Chemotherapy-induced Nausea and Vomiting

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Chemotherapy-induced Nausea and Vomiting
Intervention / Treatment

-

Contacts and Locations

Chicago

University of Illinois Cancer Center, Chicago, Illinois, United States, 60612

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Illinois at Chicago,

Karen Sweiss, PharmD, PRINCIPAL_INVESTIGATOR, University of Illinois at Chicago

Study Record Dates

2026-07