- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02341781
Observational Study of Lenalidomide in Subjects With Mantle Cell Lymphoma Who Failed Ibrutinib Treatment (MCL-004)
A Multicenter, Observational Study to Evaluate the Effectiveness of Lenalidomide (Revlimid®) in Subjects With Mantle Cell Lymphoma Who Have Relapsed or Progressed After Treatment With Ibrutinib or Are Refractory or Intolerant to Ibrutinib.
The objective of this study is to determine the effectiveness of lenalidomide in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL) following ibrutinib treatment. MCL subjects who require treatment after receiving ibrutinib therapy are considered a population with high unmet medical need. It is therefore of benefit to have data on the outcomes of treatment options available in this patient population.
An observational study design was chosen to collect the clinical data already existing or being collected for MCL subjects being treated with lenalidomide.
MCL subjects who received lenalidomide either as monotherapy or as combination treatment after having relapsed or progressed on ibrutinib treatment or were refractory or intolerant to ibrutinib treatment are eligible for the study. Lenalidomide does not need to be the next subsequent treatment after ibrutinib.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Rhineland-Palatinate
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Mainz, Rhineland-Palatinate, Alemanha, 55131
- Universitatsmedizin der Johannes Gutenberg- Universitat
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Arizona
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Phoenix, Arizona, Estados Unidos, 85054
- Mayo Clinic Scottsdale
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California
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Whittier, California, Estados Unidos, 90603
- Innovative Clinical Research Institute
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Florida
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Miami, Florida, Estados Unidos, 33136
- University of Miami and Sylvester Comprehensive Cancer
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan Comprehensive Cancer Center Division of Hematology Oncology
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Missouri
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Jefferson City, Missouri, Estados Unidos, 65101
- Columbia Comprehensive Cancer Care Clinic
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
- Hackensack University Medical Center
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New York
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New York, New York, Estados Unidos, 10065
- Weill Cornell Medical College
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28204
- Levine Cancer Institute
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania
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Texas
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Houston, Texas, Estados Unidos, 77030
- University of Texas MD Anderson Cancer Center
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Froedtert and The Medical College of Wisconsin
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Emilia-Romagna
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Bologna, Emilia-Romagna, Itália, 40138
- Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi
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Devon
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Plymouth, Devon, Reino Unido, Pl68DH
- Derriford Hospital Plymouth Oncology Center Clinical
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Mantle Cell Lymphoma (MCL) subjects who received lenalidomide, either as monotherapy or as combination treatment, after having relapsed or progressed on ibrutinib treatment or were refractory or intolerant to ibrutinib treatment.
Lenalidomide does not need to be the next subsequent treatment after ibrutinib.
Descrição
Inclusion Criteria:
- Understand and voluntarily sign an informed consent document (ICD), if applicable, prior to any collection of study-related data.
- Males or females ≥ 18 years of age at the time of signing the ICD (if informed consent is applicable)
- Diagnosis of Mantle Cell Lymphoma (MCL) as assessed by the investigator. A copy of a pathology report establishing the diagnosis of MCL must be available
- Must have received at least one dose of ibrutinib and must have met at least one of the following criteria:
A. Relapse: Subjects with relapse following initial response of CR to ibrutinib (or an ibrutinib-containing regimen). Subjects may have discontinued or completed ibrutinib treatment at the time of relapse, and there is no upper limit on the time between the last dose of ibrutinib to time of relapse. B. Progressive disease (PD): Subjects with PD following initial response of PR to ibrutinib (or an ibrutinib-containing regimen). Subjects may have discontinued or completed ibrutinib at the time of progression, and there is no upper limit on the time between the last dose of ibrutinib to time of progression. C. Refractoriness: Subjects with i. Best response of stable disease (SD) during treatment with ibrutinib (or an ibrutinib-containing regimen), and then subsequently had PD, or ii. Best response of PD at anytime while on ibrutinib (or an ibrutinib-containing regimen) D. Intolerance: Subjects requiring premature discontinuation of ibrutinib for reasons other than PD prior to the planned end of treatment. Potential reasons for premature discontinuation may include Adverse Event (AE) attributed to ibrutinib or inability to continue ibrutinib for other reasons. Subjects responding to ibrutinib treatment must have documented PD/relapse following discontinuation of ibrutinib. The reason for the premature discontinuation of ibrutinib will be recorded.
Exclusion Criteria:
- no exclusion criteria.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Relapsed,Progressed,Refractory or Intolerant to ibrutinib
MCL subjects who received lenalidomide after having relapsed or progressed on ibrutinib treatment or were refractory or intolerant to ibrutinib treatment
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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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Overall Response Rate (ORR)
Prazo: Approximately 5.7 years
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Overall Response is defined as best response of Partial Remission (PR) or Complete Remission (CR) at any time during lenalidomide treatment.
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Approximately 5.7 years
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Duration of response (DoR)
Prazo: Approximately 5.7 years
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DoR is defined as the time from the date of the initial response of at least PR (PR or CR) to the date of progressive disease (PD) or relapse.
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Approximately 5.7 years
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Adverse Events
Prazo: Approximately 5.7 years
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Number of participants with adverse events.
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Approximately 5.7 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Oliver Manzke, MD, Celgene Corporation
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 (Estimativa)
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
- CC-5013-MCL-004
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