Nausea With Vomiting Chemotherapy-InducedPhase 4NCT04150614
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
A Phase 4 study testing Granisetron Transdermal Patch, Intravenous Dexamethasone and Ondansetron in people with Nausea With Vomiting Chemotherapy-Induced, run by University of Illinois Chicago at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nausea With Vomiting Chemotherapy-Induced
- What is being tested?
- Granisetron Transdermal Patch, Intravenous Dexamethasone and Ondansetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2020to Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Concurrent use of amifostine
- Known hypersensitivity to granisetron patch or ondansetron
- Patients with a history of long QT syndrome or Torsade de Pointes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois Cancer Center
Chicago, Illinois, 60612
Karen Sweiss, PharmD, 312-996-0875, ksweis2@uic.edu
About this study
Official title: 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
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.
Read the detailed 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.
- Being tested
- Granisetron Transdermal Patch, Intravenous Dexamethasone, Ondansetron
- Keywords
- Hematopoietic Stem Cell Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granisetron Transdermal PatchDrug
Antiemetic
Intravenous DexamethasoneDrug
Antiemetic
OndansetronDrug
ondansetron
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | ARM 1 -transdermal granisetron plus intravenous dexamethasone Receives: Drug: Granisetron Transdermal Patch; Drug: Intravenous Dexamethasone |
| ARM 2 | Active comparator | ARM 2 -intravenous ondansetron plus intravenous dexamethasone Receives: Drug: Intravenous Dexamethasone; Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: Up to 21-37 days post-HSC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start14 May 2020
- Primary completionMar 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea With Vomiting Chemotherapy-InducedStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized 1:1 to either Arm 1 transdermal granisetron OR Arm 2 intravenous ondansetron
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Sweiss, University of Illinois Chicago
- Investigators
- Karen Sweiss, PharmD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150614
- Sponsor's protocol ID
- 2019-0886
- Status last verified
- Nov 2026
- First submitted
- 31 Oct 2019
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04150614
- Acronym / sponsor ID
- 2019-0886
- Keywords
- Hematopoietic Stem Cell Transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 14 May 2020 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized 1:1 to either Arm 1 transdermal granisetron OR Arm 2 intravenous ondansetron
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: Granisetron Transdermal Patch, Drug: Intravenous DexamethasoneARM 1 -transdermal granisetron plus intravenous dexamethasone |
| ARM 2 | Active comparator | Drug: Intravenous Dexamethasone, Drug: OndansetronARM 2 -intravenous ondansetron plus intravenous dexamethasone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Concurrent use of amifostine
- Known hypersensitivity to granisetron patch or ondansetron
- Patients with a history of long QT syndrome or Torsade de Pointes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Granisetron Transdermal PatchAntiemetic | Drug | Arm 1 |
| Intravenous DexamethasoneAntiemetic | Drug | ARM 2, Arm 1 |
| Ondansetronondansetron | Drug | ARM 2 |
Primary outcome
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.
Time frame: 0 hours to 24 hours post-chemotherapy
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.
6 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 21-37 days post-HSC
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karen Sweiss, PharmD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Granisetron Transdermal Patch, Intravenous Dexamethasone and Ondansetron in people with Nausea With Vomiting Chemotherapy-Induced, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen Sweiss, PharmD (312-996-0875, ksweis2@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 0 hours to 24 hours post-chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.