A Multicenter, Open-label Phase II Study of SyB L-0501 in Patients With Chronic Lymphocytic Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Response Rate [Complete Remission (CR) +Complete Remission / Incomplete (CRi) + Nodular Partial Remission (nPR) + Partial Remission (PR)] Based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Guideline
研究概览
简要总结
The purpose of this study is to investigate safety and efficacy of SyB L-0501 after 2-day intravenous infusion at a dose of 100 mg/m2/day to patients with chronic lymphocytic leukemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients who fall under any one of the following criteria are to be excluded
- •Patients who have been without treatment for less than 4 weeks after prior treatment. For patients treated with antibody therapy or underwent hematopoietic stem cell transplantation, for 3 months after prior treatment
- •Patients who enrolled other clinical studies within 4 weeks before registration for this study
- •Patients who received allogeneic stem cell transplantation in the past
- •Patients with defective p53 (17p-) confirmed by chromosome analysis (Fluorescence in situ hybridization (Fish) method)
- •Patients who are clinically diagnosed with Richter's syndrome
- •Patients with infiltration to the central nervous system (CNS) or patients with clinical symptoms of suspected infiltration to the CNS
- •Patients with multiple primary cancers or patients with a history of other malignant tumors within past 5 years, except for basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix or gastrointestinal tract
- •Patients with serious bleeding tendencies (e.g., disseminated intravascular coagulation (DIC))
- •Patients with, or confirmed in the past to have had, interstitial lung disease or pulmonary fibrosis
- •Patients with, or confirmed in the past to have had, autoimmune hemolytic anemia responds to corticosteroid therapy
- •Patients with any of the following complications
- •serious cardiac disease (e.g., myocardial infarction, ischemic heart disease, or arrhythmia requiring treatment)
- •serious, active infections (requiring intravenous administration of antibiotics, antifungal drugs, or antiviral drugs)
- •hepatic or renal dysfunction
- •accumulation of pleural effusion, pericardial effusion, or peritoneal effusion
- •uncontrollable serious gastrointestinal disease, endocrine disorder, or mental illness
- •Patients who received SyB L-0501 in the past
- •Patients with allergies to mannitol
- •Patients who need cytokine preparations such as erythropoietin or granulocyte colony stimulating factor (G-CSF) or blood transfusions at registration for this study
- •Patients positive for HIV antibody or Hepatitis C virus (HCV) antibody
- •Patients positive for Hepatitis B surface (HBs) antigen. Patients with negative results will also be checked for Hepatitis B core (HBc) antibody and HBs antibody. If either of the test results is positive, measure Hepatitis B virus (HBV)-DNA and exclude the patients with results above sensitivity
- •Patients with clinical symptom of cytomegalovirus (CMV) infection, except asymptomatic patients with CMV positive
- •Patients who are pregnant, who may possibly be pregnant, or lactating
- •Patients who do not agree to practice contraception. Male: During investigational product administration and until 6 months after final administration Female: During investigational product administration and until 4 months after final administration
- •Patients with drug addiction, narcotics addiction, and/or alcohol dependency
- •Patients otherwise judged by the investigator or sub-investigator to be unsuitable for inclusion in this study
研究组 & 干预措施
SyB L-0501
干预措施: SyB L-0501 (Drug)
结局指标
主要结局
Response Rate [Complete Remission (CR) +Complete Remission / Incomplete (CRi) + Nodular Partial Remission (nPR) + Partial Remission (PR)] Based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Guideline
时间窗: Up to 30 months
The criteria for CR, CRi, nPR and PR based on IWCLL guideline are shown below. For the criteria for nPR and PR, please refer to the description of NCI-WG response rate (CR+nPR+PR). CR: Assessment should be made at least 8 weeks after completion of administration. 1. Absence of significant lymphadenopathy (lymph nodes greater than 1.5 cm in diameter) 2. No hepatomegaly or splenomegaly 3. Absence of B symptoms 4. Meet the following laboratory test values; * lymphocyte count in peripheral blood: \<4.0×10\^9/L * neutrophil count: \>1.5×10\^9/L * platelet count: 100×10\^9/L * hemoglobin: 11.0 g/dL without transfusions 5. less than 30% of nucleated cells are lymphocytes (confirmed by bone marrow aspiration and no lymphoid nodules). 6. No new lesion emergence CRi: Fulfills all of the following criteria * Delayed anemia, thrombocytopenia, or neutropenia is observed. * Fulfills all CR criteria other than 4). * Delayed symptoms are all judged to be caused by drug.
次要结局
- Duration of Remission(Up to 30 months)
- Overall Survival (OS)(Up to 30 months)
- Adverse Events(Up to 30 months)
- Number of Subjects With Clinically Significant Laboratory Test Values of Grade 3 or More(Up to 30 months)
- Number of Subjects With Clinically Significant Physical Examination Values(Up to 30 months)
- Complete Remission Rate (CR+CRi) Based on IWCLL Guideline(Up to 30 months)
- National Cancer Institute-sponsored Working Group (NCI-WG) Response Rate (CR+nPR+PR) Based on IWCLL Guideline(Up to 30 months)
- Progression-free Survival (PFS)(Up to 30 months)