NCT01118845已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 主要终点
- The Overall Response Rate [Complete Response (CR) + Partial Response (PR)] Determined on the Basis of Revised Response Criteria for Malignant Lymphoma
研究概览
简要总结
The purpose of this study is to determine the efficacy of SyB L-0501 in combination with rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma.
详细描述
Primary Objective is to determine the efficacy, as measured by overall response rate on the basis of Revised Response Criteria for Malignant Lymphoma, of SyB L-0501 at 120 mg/m^2/day on day2 and 3 in combination with rituximab at 375 mg/m^2 on day 1 of each 21-day cycle in patients with relapsed/refractory diffuse large B-cell lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
SyB L-0501
Experimental
干预措施: SyB L-0501 (Drug)
SyB L-0501
Experimental
干预措施: Rituximab (Drug)
结局指标
主要结局
The Overall Response Rate [Complete Response (CR) + Partial Response (PR)] Determined on the Basis of Revised Response Criteria for Malignant Lymphoma
时间窗: up to 30 weeks
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 1. FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site 2. Variably FDG-avid or PET negative; regression on CT 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
次要结局
- The Complete Response (CR) Rate Determined on the Basis of Revised Response Criteria for Malignant Lymphoma(up to 30 weeks)
- Progression Free Survival (PFS)(up to 30 weeks)
- Number of Subjects With Adverse Event(up to 30 weeks)
- Number of Adverse Events(up to 30 weeks)
- Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values(up to 30 weeks)
- Number of Subjects With Grade ≥3 Physical Examination Finding(up to 30 weeks)
- Concomitant Medication Usage(up to 30 weeks)
- The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Japan(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)
- The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Japan(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)
- The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Japan(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)
- The Half-life Period (t1/2) of Unchanged SyB L-0501 in Japan(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)
- The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Korea(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)
- The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Korea(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)
- The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Korea(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)
- The Half-life Period (t1/2) of Unchanged SyB L-0501 in Korea(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)
研究者
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