BMT-08: Um Estudo Comparativo de Eficácia de Granisetrona Transdérmica a Ondansetrona
BMT-08: Um Estudo Comparativo de Eficácia da Eficácia e Segurança de Granisetrona Transdérmica a Ondansetrona na Prevenção de Náuseas e Vômitos em Pacientes Submetidos a Quimioterapia Preparativa e Transplante de Células Tronco Hematopoiéticas
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 4
Contactos e Locais
Contato de estudo
- Nome: Karen Sweiss, PharmD
- Número de telefone: 312-996-0875
- E-mail: ksweis2@uic.edu
Locais de estudo
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Recrutamento
- University of Illinois Cancer Center
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Contato:
- Karen Sweiss, PharmD
- Número de telefone: 312-996-0875
- E-mail: ksweis2@uic.edu
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Arm 1
ARM 1 -transdermal granisetron plus intravenous dexamethasone |
Antiemetic Antiemetic |
|
Comparador Ativo: ARM 2
ARM 2 -intravenous ondansetron plus intravenous dexamethasone |
Antiemetic ondansetron |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
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.
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Karen Sweiss, PharmD, University of Illinois Chicago
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2019-0886
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