A Study of MabThera/Rituxan (Rituximab) in Patients With Relapsed Centroblastic Centrocytic Non-Hodgkin's Lymphoma
17 de novembro de 2014 atualizado por: Hoffmann-La Roche
Clinical Response in Patients With Relapsed Centroblastic Centrocytic Non-Hodgkin's Lymphoma After Treatment With Anti-CD20 Antibody IDEC C2B8 (MabThera)
This study will evaluate the efficacy and safety of MabThera/Rituxan in patients with relapsed low-grade centroblastic centrocytic non-Hodgkin's lymphoma.
Patients will receive once-weekly intravenous MabThera/Rituxan for 4 weeks; responding patients will be treated a second time in case of relapse (defined as progression after complete or partial response).
The anticipated time on study treatment is <3 months.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
38
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Erlangen, Alemanha, 91054
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Grenzach-wyhlen, Alemanha, 79639
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Göttingen, Alemanha, 37075
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Hannover, Alemanha, 30625
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Homburg/saar, Alemanha, 66424
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Köln, Alemanha, 50924
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Muenchen, Alemanha, 80336
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Muenchen, Alemanha, 81377
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Muenster, Alemanha, 48129
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Stuttgart, Alemanha, 70376
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Tübingen, Alemanha, 72076
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- adult patients >= 18 years of age;
- centrocytic centroblastic non-Hodgkin's lymphoma stage III-IV;
- relapse after chemotherapy (with or without interferon maintenance therapy).
Exclusion Criteria:
- primary refractory lymphomas;
- more than 3 relapses of centroblastic centrocytic non-Hodgkin's lymphoma;
- clinically significant cardiac disease.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: MabThera/Rituxan
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375 mg/m2 iv weekly for 4 weeks; for responders to first course of therapy a second course is possible after relapse
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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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Percentage of Participants With a Complete Remission (CR) or Partial Remission (PR)
Prazo: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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Percentage of participants with a CR, PR at the end of the first cycle of treatment (Week 4).
CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1.500/ microliter (µL), hemoglobin (Hb) >12 grams per deciliter (g/dL), and platelets >100,000/µL.
PR was defined as a less than (<) 50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts.
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Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Participants With a Clinical Response
Prazo: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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Clinical response was defined as the best response after the first 4 weeks of treatment cycle by the following categories: CR, PR, minor response (MR), stable disease (SD), and progressive disease (PD).
CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1,500/μL, Hb >12 g/dL, and platelets >100,000/μL.
PR was defined as <50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts.
MR was defined as tumor regression ≥25% and <50%.
SD was defined as tumor regression <25%, no new manifestations, and progression ≤25%.
PD was defined as no new lymphoma associated symptoms or an increase in the size of manifestations by more than 25%.
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Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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Time to Best Response
Prazo: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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The median time, in months, from start of the treatment (first application) until best response (PR or CR).
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Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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Duration of Remission
Prazo: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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Median time, in months, between the documentation of CR or PR and PD in clinical responders.
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Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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Time to Progression
Prazo: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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The median time, in months, from the start of treatment (first application) until detection of PD.
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Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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Overall Survival (OS)
Prazo: Enrollment into study until end of follow-up or death. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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OS was defined as the time, in months, between enrollment into the study and death, due to any cause.
Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.
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Enrollment into study until end of follow-up or death. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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Number of Participants With a Clinical Response to Re-Treatment
Prazo: First application in the second treatment cycle until progression of disease. The median length of follow-up was 4.6 months (range: 0.5-20.6 months).
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Clinical response was defined as the best response after the second 4 weeks of treatment cycle by the following categories: CR, PR, MR, SD, and PD.
CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1,500/μL, Hb >12 g/dL, and platelets >100,000/μL.
PR was defined as <50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts.
MR was defined as tumor regression ≥25% and <50%.
SD was defined as tumor regression <25%, no new manifestations, and progression ≤25%.
PD was defined as no new lymphoma associated symptoms or an increase in the size of manifestations by more than 25%.
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First application in the second treatment cycle until progression of disease. The median length of follow-up was 4.6 months (range: 0.5-20.6 months).
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de janeiro de 1997
Conclusão Primária (Real)
1 de fevereiro de 2008
Conclusão do estudo (Real)
1 de fevereiro de 2008
Datas de inscrição no estudo
Enviado pela primeira vez
25 de novembro de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
25 de novembro de 2013
Primeira postagem (Estimativa)
2 de dezembro de 2013
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
3 de dezembro de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de novembro de 2014
Última verificação
1 de outubro de 2014
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças do sistema imunológico
- Neoplasias por Tipo Histológico
- Neoplasias
- Distúrbios Linfoproliferativos
- Doenças Linfáticas
- Distúrbios imunoproliferativos
- Linfoma
- Linfoma Não-Hodgkin
- Efeitos Fisiológicos das Drogas
- Agentes Antirreumáticos
- Agentes Antineoplásicos
- Fatores imunológicos
- Agentes Antineoplásicos Imunológicos
- Rituximabe
Outros números de identificação do estudo
- M39004
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