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- Ensaio Clínico NCT02142049
Ibrutinib and Lenalidomide With Dose Adjusted EPOCH-R in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma
A Multicenter Study of Ibrutinib and Lenalidomide in Combination With DA-EPOCH-R in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
This is a Phase 1b, open-label, non-randomized multicenter study conducted in 2 parts. Part 1, will determine the MTD of the combination of ibrutinib, lenalidomide and DA-EPOCH-R in subjects with DLBCL.
Ibrutinib will be administered at a fixed dose of 560 mg and lenalidomide will be dose-escalated. DA-EPOCH-R will be given at standard doses.
For Part 2, the MTD determined in Part 1 will be the dose used for all subjects. If no MTD is identified, then subjects in Part 2 will be treated with the maximum administered doses (MAD, treatment doses from dose Level 4).
The primary objective for Part 2 is to determine the ORR of ibrutinib and lenalidomide in combination with DA-EPOCH-R in subjects with ABC DLBCL as analyzed by gene expression profiling when treated at recommended phase 2 dose (RP2D).
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Locais de estudo
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California
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Duarte, California, Estados Unidos, 91010
- SITE-1
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Los Angeles, California, Estados Unidos, 90095
- SITE-2
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Orange, California, Estados Unidos, 92868
- SITE-10
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- SITE-3
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- SITE-5
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Bethesda, Maryland, Estados Unidos, 20892
- SITE-6
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- SITE-4
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87106
- SITE-8
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New York
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Stony Brook, New York, Estados Unidos, 11794
- SITE-9
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425
- SITE-7
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Major inclusion criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
- Pathologically confirmed relapsed/refractory DLBCL
- Subjects must have ≥1 measurable disease site on CT scan (≥ 1.5 cm in longest dimension).
Adequate hepatic and renal function:
- AST or ALT ≤2.5 x ULN
- Serum Creatinine ≤ 2.0 mg/dL and creatinine clearance ≥60 mL/min/1.73
- Bilirubin ≤1.5 x ULN
Adequate hematologic function:
- ANC >1,000 cells/mm3
- Platelets ≥75,000 cells/mm3
- Hemoglobin ≥8.0 g/dL
- Prothrombin time (PT) and activated partial thromboplastin time (aPTT) must be ≤1.5 x the upper limit of the normal range (ULN)
- Must be registered into the Revlimid REMS™program and be willing to comply with the requirements of Revlimid REMS™.
Major Exclusion Criteria:
- Known central nervous system lymphoma
- Any chemotherapy, external beam radiation therapy, or anti-cancer antibodies within 2 weeks
- Radio- or toxin-immunoconjugates within 10 weeks
- Prior allogenetic stem cell (or other organ) transplant within 6 months or any evidence of active graft-versus-host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug
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 |
---|---|
Experimental: Part 1: Dose Level 1
Ibrutinib 560 mg PO + DA-EPOCH-R
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Ibrutinibe
Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
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Experimental: Part 1: Dose Level 2
Ibrutinib 560 mg (PO) +lenalidomide 15 mg (PO) + DA-EPOCH-R
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Ibrutinibe
Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
Lenalidomida
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Experimental: Part 1: Dose Level 3
Ibrutinib 560 mg (PO) +lenalidomide 20 mg (PO) + DA-EPOCH-R
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Ibrutinibe
Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
Lenalidomida
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Experimental: Part 1: Dose Level 4
Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R
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Ibrutinibe
Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
Lenalidomida
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Experimental: Part 2: RP2D
Recommended Phase 2 Dose(RP2D): Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R
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Ibrutinibe
Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
Lenalidomida
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Number of Participants With Dose-Limiting Toxicities as a Measure of Safety and Tolerability
Prazo: 1 year after last subjects received the first dose
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Part-1: To determine the maximum tolerated dose (MTD) of the combination of ibrutinib and lenalidomide with dose adjusted EPOCH-R
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1 year after last subjects received the first dose
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Number of Participants With Complete Responses (CR) and Partial Responses (PR) as a Measure of Efficacy-ORR
Prazo: 1 year after last subjects received the first dose
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Part 2 - Overall Response rate will be defined as the proportion of subjects who achieve either a Complete Response or a Partial Response according to the international Working Group Response Criteria for NHL as assessed by investigator.
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1 year after last subjects received the first dose
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Number of Participants With Complete Responses (CR) and Partial Responses (PR) as a Measure of Efficacy
Prazo: 1 year after last subjects received the first dose
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Part-1: Overall Response rate (ORR) will defined as the proportion of subjects who achieve either a CR or a PR according to the international Working Group Response Criteria for NHL as assessed by investigator.
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1 year after last subjects received the first dose
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Number of Subjects With Adverse Events as a Measure of Safety and Tolerability
Prazo: 1 year after last subjects received the first dose
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Part 2: The frequency (number and percentage) of treatment-emergent adverse events will be reported.
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1 year after last subjects received the first dose
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Progression Free Survival (PFS) and Overall Survival (OS) as a Measure of Efficacy
Prazo: From initial dose date until the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 1 year after the last subject received the first dose, up to 36 months at the most.
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Part 2: PFS will be measured as time from first study drug administration to disease progression or death from any cause.
OS will be measured from the time of first study drug administration until the date of death using Kaplan-Meier methodology.
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From initial dose date until the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 1 year after the last subject received the first dose, up to 36 months at the most.
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Duration of Response (DOR)
Prazo: From initial response date until the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 1 year after the last subject received the first dose.
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Part 2: DOR will be measured from the time by which the measurement criteria are met for CR or PR until the first date by which recurrent or progressive disease is objectively documented.
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From initial response date until the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 1 year after the last subject received the first dose.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Jutta Neuenburg, MD, Pharmacyclics LLC (An AbbVie Company)
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (Estimativa)
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
- Doenças do sistema imunológico
- Neoplasias por Tipo Histológico
- Neoplasias
- Distúrbios Linfoproliferativos
- Doenças Linfáticas
- Distúrbios imunoproliferativos
- Linfoma Não-Hodgkin
- Linfoma
- Linfoma de Células B
- Linfoma de Células B Grandes Difuso
- Efeitos Fisiológicos das Drogas
- Agentes Antineoplásicos
- Fatores imunológicos
- Inibidores de angiogênese
- Agentes Moduladores da Angiogênese
- Substâncias de crescimento
- Inibidores de crescimento
- Lenalidomida
Outros números de identificação do estudo
- PCYC-1124-CA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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