BMT-08: een vergelijkende effectiviteitsstudie van transdermale granisetron naar ondansetron
BMT-08: een vergelijkende effectiviteitsstudie van de werkzaamheid en veiligheid van transdermale granisetron en ondansetron bij de preventie van misselijkheid en braken bij patiënten die preparatieve chemotherapie en hematopoëtische stamceltransplantatie ondergaan
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Fase 4
Contacten en locaties
Studiecontact
- Naam: Karen Sweiss, PharmD
- Telefoonnummer: 312-996-0875
- E-mail: ksweis2@uic.edu
Studie Locaties
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Illinois
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Chicago, Illinois, Verenigde Staten, 60612
- Werving
- University of Illinois Cancer Center
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Contact:
- Karen Sweiss, PharmD
- Telefoonnummer: 312-996-0875
- E-mail: ksweis2@uic.edu
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion 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
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Arm 1
ARM 1 -transdermal granisetron plus intravenous dexamethasone |
Antiemetic Antiemetic |
|
Actieve vergelijker: ARM 2
ARM 2 -intravenous ondansetron plus intravenous dexamethasone |
Antiemetic ondansetron |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
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.
Tijdsspanne: 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. |
0 hours to 24 hours post-chemotherapy
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
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.
Tijdsspanne: 24 hours to 120 hours post-chemotherapy
|
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. |
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.
Tijdsspanne: 24 hours to 120 hours post-chemotherapy
|
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.
Tijdsspanne: Up to 7 days after the preparative regimen
|
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.
Tijdsspanne: Up to 21 - 37 days post-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.
Tijdsspanne: Up to 21 - 37 days post-HSCT
|
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.
Tijdsspanne: Up to 21-37 days post-HSC
|
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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Karen Sweiss, PharmD, University of Illinois Chicago
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2019-0886
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