A Study of Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)
30 de março de 2016 atualizado por: Hoffmann-La Roche
A Multicenter, Single-Arm, Phase II Study to Evaluate the Efficacy and Safety of Rituximab Plus Fludarabine and Cyclophosphamide (FCR) as First-Line Treatment in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)
This study will evaluate the efficacy and safety of rituximab in combination with chemotherapy (fludarabine and cyclophosphamide) in participants with B-cell CLL.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
34
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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Buenos Aires, Argentina, C1280AEB
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Buenos Aires, Argentina, 1406
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Buenos Aires, Argentina, C1114AAN
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Buenos Aires, Argentina, C1431FWO
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Córdoba, Argentina, 5016
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La Plata, Argentina, B1897GOL
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Pilar, Argentina, B1629ODT
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Rosario, Argentina, S2000DSV
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Caracas, Venezuela, 2122
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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 participants greater than or equal to (≥) 18 years of age
- B-cell CLL
- No previous treatment for leukemia
Exclusion Criteria:
- History of other malignancies within 2 years before study entry, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, prostate cancer, or breast cancer
- Comorbid condition requiring long-term (greater than [>] 1 month) systemic corticosteroids during study treatment
- Known infection with hepatitis B or C virus or with human immunodeficiency virus (HIV)
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: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Rituximab + Fludarabine + Cyclophosphamide
Participants will receive rituximab (375 milligrams per meter-squared [mg/m^2] intravenously [IV]) on Cycle 1 Day 1, followed by fludarabine (25 mg/m^2 once daily IV) and cyclophosphamide (250 mg/m^2 once daily IV) for Days 2 to 4 of Cycle 1. Then rituximab (500 mg/m^2 IV) will be administered on Day 1 of Cycles 2 to 6, followed by IV fludarabine (25 mg/m^2 once daily IV) and cyclophosphamide (250 mg/m^2 once daily IV) on Days 1 to 3 of Cycles 2 to 6.
Each cycle will be 28 days or 4 weeks in length, and the overall duration of treatment will be approximately 6 months.
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Cyclophosphamide will be administered IV at 250 mg/m^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6.
Each cycle will be 28 days or 4 weeks in length.
Fludarabine will be administered IV at 25 mg/m^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6.
Each cycle will be 28 days or 4 weeks in length.
Rituximab will be administered IV at 375 mg/m^2 on Day 1 of Cycle 1 and then at 500 mg/m^2 on Day 1 of Cycles 2 to 6.
Each cycle will be 28 days or 4 weeks in length.
Outros nomes:
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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 Death or Disease Progression
Prazo: Up to 5 years (from Baseline until disease progression or death, whichever occurred first)
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Treatment response was monitored throughout the study and assessed using standardized criteria.
Disease progression was defined as the occurrence of at least one of the following: greater than or equal to (≥) 50 percent (%) increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 centimeters (cm) from Baseline as determined by measurement below the costal margin, or ≥50% increase in the number of circulating lymphocytes.
The percentage of participants with death or documented disease progression at any time during the study was calculated.
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Up to 5 years (from Baseline until disease progression or death, whichever occurred first)
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Progression-Free Survival (PFS)
Prazo: Up to 5 years (from Baseline until disease progression or death, whichever occurred first)
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Treatment response was monitored throughout the study and assessed using standardized criteria.
Disease progression was defined as the occurrence of at least one of the following: ≥50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or ≥50% increase in the number of circulating lymphocytes.
PFS was defined as the time from study inclusion until first event of disease progression or death and was estimated using Kaplan-Meier analysis.
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Up to 5 years (from Baseline until disease progression or death, whichever occurred first)
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Percentage of Participants Who Died
Prazo: Up to 5 years (from Baseline until death)
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Participants were followed for survival throughout the study.
The percentage of participants who died of any cause during the study was calculated.
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Up to 5 years (from Baseline until death)
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Overall Survival (OS)
Prazo: Up to 5 years (from Baseline until death)
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Participants were followed for survival throughout the study.
OS was defined as the time from study inclusion until death from any cause and was estimated using Kaplan-Meier analysis
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Up to 5 years (from Baseline until death)
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Percentage of Participants With Complete Response (CR), Nodular Partial Response (nPR), or Partial Response (PR)
Prazo: Up to 4 years (assessed every 3 months during 6-month treatment period, every 2 months during 6-month safety follow-up, then every 3 months during 3-year safety follow-up)
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Treatment response was monitored throughout the study and assessed using standardized criteria.
CR was defined as hemoglobin ≥11 grams per deciliter (g/dL), lymphocytes less than (<) 4000 cells per cubic millimeter (cells/mm^3), neutrophils greater than (>) 1500 cells/mm^3, platelets >100,000 cells/mm^3, bone marrow (BM) biopsy with <30% lymphocytes with no lymphocytic infiltrates, no evidence of lymphoid nodules on physical exam, and performance status of 0. PR was defined as >50% decrease in size of enlarged lymph nodes, hepatomegaly, and splenomegaly, with peripheral counts meeting the same criteria as CR or ≥50% improvement from pre-treatment values.
Participants with lymphoid nodules on BM biopsy who otherwise met CR criteria were considered nPR.
The percentage of participants with each level of best overall response was calculated.
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Up to 4 years (assessed every 3 months during 6-month treatment period, every 2 months during 6-month safety follow-up, then every 3 months during 3-year safety follow-up)
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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 fevereiro de 2006
Conclusão Primária (Real)
1 de dezembro de 2014
Conclusão do estudo (Real)
1 de dezembro de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
24 de agosto de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
24 de agosto de 2015
Primeira postagem (Estimativa)
26 de agosto de 2015
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
2 de maio de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
30 de março de 2016
Última verificação
1 de março de 2016
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
- Leucemia de Células B
- Leucemia
- Leucemia Linfocítica Crônica de Células B
- Leucemia Linfóide
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Antirreumáticos
- Agentes Antineoplásicos
- Agentes imunossupressores
- Fatores imunológicos
- Agentes Antineoplásicos Alquilantes
- Agentes Alquilantes
- Agonistas Mieloablativos
- Agentes Antineoplásicos Imunológicos
- Ciclofosfamida
- Rituximabe
- Fludarabina
Outros números de identificação do estudo
- ML18429
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