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

Last updated: September 5, 2024
Sponsor: University of Illinois at Chicago
Overall Status: Active - Recruiting

Phase

4

Condition

Vomiting

Lactose Intolerance

Colic

Treatment

Granisetron Transdermal Patch

Ondansetron

Intravenous Dexamethasone

Clinical Study ID

NCT04150614
2019-0886
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18-75 years at time of enrollment receiving either a preparative regimen andeither 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 duringprotocol therapy. No patients will be removed from these treatments for studyenrollment purposes.

  • No chronic phenothiazine administration as an antipsychotic agent (patients mayreceive prochlorperazine and other phenothiazines as rescue antiemetic therapy). Nopatients will be removed from these treatments for study enrollment purposes.

  • No known hypersensitivity to granisetron

Exclusion

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 Design

Total Participants: 90
Treatment Group(s): 3
Primary Treatment: Granisetron Transdermal Patch
Phase: 4
Study Start date:
May 14, 2020
Estimated Completion Date:
July 31, 2026

Study 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.

Connect with a study center

  • University of Illinois Cancer Center

    Chicago, Illinois 60612
    United States

    Active - Recruiting

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