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

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.

• 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: Up to 21-37 days post-HSC]