- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01118845
Study of SyB L-0501 in Combination With Rituximab to Treat Relapsed/Refractory Diffuse Large B-Cell Lymphoma
A Multinational, Multicenter, Open-Label Phase II Study of SyB L-0501 in Combination With Rituximab in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Akita, Japão
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Fukuoka, Japão
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Kagoshima, Japão
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Kyoto, Japão
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Aichi
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Nagoya, Aichi, Japão
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Ehime
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Matsuyama, Ehime, Japão
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Fukuoka
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Kurume, Fukuoka, Japão
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Gunma
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Maebashi, Gunma, Japão
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Hokkaido
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Sapporo, Hokkaido, Japão
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Ishikawa
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Kanazawa, Ishikawa, Japão
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Kanagawa
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Isehara, Kanagawa, Japão
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Kumamoto
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Ninomaru, Kumamoto, Japão
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Miyagi
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Sendai, Miyagi, Japão
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Okayama
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Kita-ku, Okayama, Japão
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Kurashiki, Okayama, Japão
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Saitama
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Hidaka, Saitama, Japão
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Shimane
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Izumo, Shimane, Japão
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Tokyo
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Chuo-ku, Tokyo, Japão
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Busan
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Seo-gu, Busan, Republica da Coréia
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Daegu
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Jung-gu, Daegu, Republica da Coréia
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, Republica da Coréia
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Jeonnam
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Hwasun-gun, Jeonnam, Republica da Coréia
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Seoul
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Gangnam-gu, Seoul, Republica da Coréia
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Seodaemun-gu, Seoul, Republica da Coréia
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Songpa-gu, Seoul, Republica da Coréia
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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:
- Patients with documented Cluster of differentiation 20 (CD20)-positive for lymphoma cells
- Patients with measurable lesions
- Patients with measurable lesions >1.5 cm in major axes
- Relapsed or refractory after 1 to 3 prior therapeutic treatments for diffuse large B-cell lymphoma.
- Patients who are expected to survive for at least 3 months
- Patients aged from 20 to 75 years at the time informed consent is obtained
- Performance Status (P.S.) of 0 to 1 at initial administration of the study drug
- Patients with adequately maintained organ functions
- Patients capable of personally giving voluntary informed consent in writing to participate in the study
Exclusion Criteria:
- Patients who have been without treatment for less than 3 weeks after prior treatment
- Patients who can be candidates for autologous peripheral blood stem cell transplantation at the discretion of the investigator.
- Patients who received adequate prior treatments and did not respond to any of them.
- Patients with central nervous system (CNS) involvement or patients with clinical symptoms suggestive of CNS involvement.
- Patients with serious, active infections
- Patients with serious complications
- Patients with complications or medical history of serious cardiac disease
- Patients with serious gastrointestinal symptoms
- Patients with malignant pleural effusion, cardiac effusion, or ascites retention
- Patients positive for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody, or HIV antibody
- Patients with serious bleeding tendencies
- Patients with a fever of 38.0°C or higher
- Patients with, or confirmed in the past to have had, interstitial pneumonia, pulmonary fibrosis, or pulmonary emphysema
- Patients with active multiple primary cancer or patients with a history of other malignant cancer within the past 5 years, except for basal cell cancer of the skin, squamous cell cancer, or cervical cancer in situ
- Patients with, or confirmed in the past to have had, autoimmune hemolytic anemia
- Patients who received SyB L-0501 in the past
- Patients who received cytokine preparation such as erythropoietin or granulocyte colony-stimulating factor (G-CSF) or blood transfusions within 2 weeks before the examination at registration for this study
- Patients who received other investigational products or unapproved medication within 3 months before registration in this study
Plano de estudo
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: SyB L-0501
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The administration of SyB L-0501 at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. SyB L-0501 60 mg/m^2, 90 mg/m^2 or 120 mg/m^2/day on Day 2 and Day 3 will be followed by 18 days of observation.
Outros nomes:
The administration of rituximab at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles.
Dose modifications are not permitted.
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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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The Overall Response Rate [Complete Response (CR) + Partial Response (PR)] Determined on the Basis of Revised Response Criteria for Malignant Lymphoma
Prazo: up to 30 weeks
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CR: Disappearance of all evidence of disease. PR: Regression of measurable disease and no new sites. For the criteria for CR, See Outcome measure 2 description. The criteria for PR is as below. Nodal Masses: more than 50% decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes
Spleen, Liver: more than 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified |
up to 30 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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The Complete Response (CR) Rate Determined on the Basis of Revised Response Criteria for Malignant Lymphoma
Prazo: up to 30 weeks
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The criteria for CR is as below Nodal Masses:
Spleen, Liver: Not palpable, nodules disappeared Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative |
up to 30 weeks
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Progression Free Survival (PFS)
Prazo: up to 30 weeks
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PFS = day of the first PFS event - day of start of study treatment + 1 The definitions of PFS event are as below.
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up to 30 weeks
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Number of Subjects With Adverse Event
Prazo: up to 30 weeks
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up to 30 weeks
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Number of Adverse Events
Prazo: up to 30 weeks
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up to 30 weeks
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Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values
Prazo: up to 30 weeks
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Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE). grade 1 : mild grade 2 : moderate grade 3 : severe grade 4 : life threatening or disabling grade 5 : death related to adverse event |
up to 30 weeks
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Number of Subjects With Grade ≥3 Physical Examination Finding
Prazo: up to 30 weeks
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up to 30 weeks
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Concomitant Medication Usage
Prazo: up to 30 weeks
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up to 30 weeks
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The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Japan
Prazo: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Japan
Prazo: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Japan
Prazo: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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The Half-life Period (t1/2) of Unchanged SyB L-0501 in Japan
Prazo: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Korea
Prazo: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Korea
Prazo: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Korea
Prazo: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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The Half-life Period (t1/2) of Unchanged SyB L-0501 in Korea
Prazo: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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Colaboradores e Investigadores
Patrocinador
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
- Doenças do sistema imunológico
- Neoplasias por Tipo Histológico
- Neoplasias
- Distúrbios Linfoproliferativos
- Doenças Linfáticas
- Distúrbios imunoproliferativos
- Linfoma de Células B
- Linfoma
- Linfoma de Células B Grandes Difuso
- Linfoma Não-Hodgkin
- Linfoma de Células do Manto
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Antirreumáticos
- Agentes Antineoplásicos
- Fatores imunológicos
- Agentes Antineoplásicos Alquilantes
- Agentes Alquilantes
- Agentes Antineoplásicos Imunológicos
- Cloridrato de Bendamustina
- Rituximabe
Outros números de identificação do estudo
- 2010001
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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SymBio PharmaceuticalsConcluído
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SymBio PharmaceuticalsConcluídoTumor Sólido AvançadoJapão
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Emory UniversityBristol-Myers Squibb; National Cancer Institute (NCI); National Institutes of...Ativo, não recrutandoLinfoma de Hodgkin | Linfoma de Hodgkin Recorrente | Linfoma de Hodgkin refratário | Linfoma de Hodgkin ClássicoEstados Unidos