BMT-08: Transdermaalisen granisetronin ja ondansetronin vertaileva tehokkuustutkimus
BMT-08: Vertaileva tehokkuustutkimus transdermaalisen granisetronin tehosta ja turvallisuudesta ondansetroniin pahoinvoinnin ja oksentelun ehkäisyssä potilailla, jotka saavat valmistavaa kemoterapiaa ja hematopoieettisten kantasolujen siirtoa
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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Vaihe 4
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Karen Sweiss, PharmD
- Puhelinnumero: 312-996-0875
- Sähköposti: ksweis2@uic.edu
Opiskelupaikat
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Illinois
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Chicago, Illinois, Yhdysvallat, 60612
- Rekrytointi
- University of Illinois Cancer Center
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Ottaa yhteyttä:
- Karen Sweiss, PharmD
- Puhelinnumero: 312-996-0875
- Sähköposti: ksweis2@uic.edu
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-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Active Comparator: Arm 1
ARM 1 -transdermal granisetron plus intravenous dexamethasone |
Antiemetic Antiemetic |
|
Active Comparator: ARM 2
ARM 2 -intravenous ondansetron plus intravenous dexamethasone |
Antiemetic ondansetron |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
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.
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
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.
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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
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To compare the occurrence of treatment-related adverse events (AE) between patients receiving transdermal Granisetron versus intravenous Ondansetron.
Aikaikkuna: Up to 21 - 37 days post-HSCT
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Treatment-related adverse events (AE) will be evaluated using NCI CTCAE version 5. |
Up to 21 - 37 days post-HSCT
|
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To compare quality of life throughout the course of HSCT between patients receiving transdermal Granisetron versus intravenous Ondansetron.
Aikaikkuna: Up to 21-37 days post-HSC
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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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Karen Sweiss, PharmD, University of Illinois Chicago
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 2019-0886
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