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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | ARM 1 -transdermal granisetron plus intravenous dexamethasone |
|
| ARM 2 | Active Comparator | ARM 2 -intravenous ondansetron plus intravenous dexamethasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Granisetron Transdermal Patch | Drug | Antiemetic |
| |
| Intravenous Dexamethasone |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen Sweiss, PharmD | Contact | 312-996-0875 | ksweis2@uic.edu |
| Name | Affiliation | Role |
|---|---|---|
| Karen Sweiss, PharmD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois Cancer Center | Recruiting | Chicago | Illinois | 60612 | United States |
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Randomized 1:1 to either Arm 1 transdermal granisetron OR Arm 2 intravenous ondansetron
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| Drug |
Antiemetic |
|
| Ondansetron | Drug | ondansetron |
|
| 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 |
| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |