Brometo de Sepantrônio para o Tratamento de Linfoma de Células B de Alto Grau
Um estudo de fase 2, multicêntrico, aberto de variação de dose de brometo de sepantrônio em pacientes com linfoma de células B de alto grau rearranjado c-Myc recidivante/refratário (HGBCL)
This is a multi-center Phase 2 study to determine the safety and efficacy of sepantronium bromide (SepB) in adult patients with relapsed or refractory high-grade B-cell lymphoma
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This is a multi-center, open label, dose-ranging Phase 2 study evaluating the safety and efficacy of SepB in patients with relapsed/refractory c-Myc rearranged HGBCL.
Cohorts of three patients will be enrolled at each dose level for SepB with expansion to six patients, if necessary, to assess toxicity.
Following the completion of 2 cycles of treatment of each cohort, an independent Data Monitoring Committee (DMC) will review the safety data to assess study drug related toxicities from the current cohort. Following this review, a decision will be made to continue dose escalation to the next dose level, to declare that a given dose level is the level of dose-limiting toxicity (DLT) or to further explore toxicity at the dose level in question by enrolling additional subjects to a maximum of six subjects at that level.
An additional 6 patients will be enrolled at the recommended Phase 2 dose (RP2D). The RP2D will be established on the basis of the maximally tolerated dose between the two specified dose levels as well as other relevant data, including clinical signals of activity, pharmacokinetic (PK) and pharmacodynamic (PD) data.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Beijing, China
- Beijing Cancer Hospital
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Guangzhou, China
- Sun Yat-sen University Cancer Center
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Henan, China
- Henan Cancer Hospital
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Pudong, China
- Shanghai East Hospital
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Tianjin, China
- Tianjin Cancer Hospital
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Wuhan, China
- Tongji Hospital
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Busan, Coréia do Sul
- Dong-A University Hospital
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Busan, Coréia do Sul
- Inje University Haeundae Paik hospital
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Seoul, Coréia do Sul
- Samsung Medical Center
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Seoul, Coréia do Sul
- Seoul National University Hospital
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Seoul, Coréia do Sul
- Seoul St.Mary's Hospital
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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:
- Confirmed histologic diagnosis of c-Myc rearranged high-grade B-cell lymphoma
- Relapse or refractory disease after at least one previous line of therapy
- Measurable disease as defined by 2014 Lugano classification
- ECOG performance status of 0-2
- Acceptable coagulation parameters
Exclusion Criteria:
- Allogeneic transplant within 3 months
- Autologous transplant without resolution of post-transplant cytopenias
- Known CNS involvement
- Average QT/QTc interval duration > 450 msec
- Inadequate marrow, hepatic or renal function
- Unresolved Grade 2 or greater toxicities from prior anticancer therapy
- Radiotherapy within prior 4 weeks
- Requires systemic immunosuppressive therapy
- Positive for Hepatis B or Hepatis C
- Seropositive for HIV
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Cohort 1
Cohort 1 will receive a dose of 3.6 mg/m2/day of sepantronium bromide |
continuous intravenous infusion
Outros nomes:
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Experimental: Cohort 2
Cohort 1 will receive a dose of 4.8 mg/m2/day of sepantronium bromide |
continuous intravenous infusion
Outros nomes:
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Experimental: Recommended Phase 2 Dose - Cohort 3
The recommended Phase 2 dose will be established based on the safety, pharmacokinetic and pharmacodynamic data from Cohort 1 and Cohort 2 |
continuous intravenous infusion
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Safety and tolerability and recommended Phase 2 dose of sepantronium bromide
Prazo: From time of signing informed consent through 30 days after the last dose of study drug, an average of 6 months
|
Frequency, severity and relatedness of adverse events and the frequency of adverse events requiring discontinuation of study drug or dose reductions |
From time of signing informed consent through 30 days after the last dose of study drug, an average of 6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Overall response rate
Prazo: From first dose through the last dose of study drug, an average of 6 months
|
The ORR is defined as the percentage of participants who achieve either a Partial Response or Complete Response at any time during the treatment phase |
From first dose through the last dose of study drug, an average of 6 months
|
|
Complete response rate
Prazo: From first dose of study drug through the last dose of study drug, an average of 6 months
|
Percentage of patients who experience a confirmed Complete Response at any time during the treatment phase |
From first dose of study drug through the last dose of study drug, an average of 6 months
|
|
Duration of response
Prazo: From first dose of study drug through to time of progression, an average of 6 months
|
Time from the first documentation of a Complete Response or a Partial Response until the time to objective tumor progression |
From first dose of study drug through to time of progression, an average of 6 months
|
|
Clinical benefit rate
Prazo: From first dose of study drug through the last dose of study drug, an average of 6 months
|
Proportion of patients who achieve a Complete Response, Partial Response or Stable Disease during the treatment phase |
From first dose of study drug through the last dose of study drug, an average of 6 months
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Overall survival
Prazo: From first dose of study drug through date of death, irrespective of cause, an average of 6 months
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The time from the first dose of study drug until death from any cause or date of last follow-up for living and lost to follow-up patients |
From first dose of study drug through date of death, irrespective of cause, an average of 6 months
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Progression Free Survival
Prazo: From first dose of study drug through relapse, disease progression or death due to any cause, an average of 12 months
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The time from first dose until relapse, disease progression or death due to any cause |
From first dose of study drug through relapse, disease progression or death due to any cause, an average of 12 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Vernon Jiang, PhD, Cothera Bioscience
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
- Processos Patológicos
- Neoplasias
- Atributos da doença
- Doenças do sistema imunológico
- Infecções
- Doenças Virais
- Neoplasias por Tipo Histológico
- Infecções por vírus de DNA
- Distúrbios Linfoproliferativos
- Distúrbios imunoproliferativos
- Linfoma
- Infecções pelo vírus Epstein-Barr
- Infecções Herpesviridae
- Infecções por Vírus Tumorais
- Condições Patológicas, Sinais e Sintomas
- Doenças hemic e linfáticas
- Recorrência
- Linfoma de Células B
- Linfoma de Células B Grandes Difuso
- Linfoma de Burkitt
- Linfoma Não-Hodgkin
- Doenças Linfáticas
- sepantronium
Outros números de identificação do estudo
- PC002-01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Prazo de Compartilhamento de IPD
Beginning 9 months and ending 36 months following article publication.
Critérios de acesso de compartilhamento IPD
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
Informações sobre medicamentos e dispositivos, documentos de estudo
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