NCT02981745Unknown1 期
Study of Safety, Efficacy and Pharmacokinetics of CT-1530 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia
Centaurus Biopharma Co., Ltd.1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年4月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I)
研究概览
简要总结
This is a phase I study of BTK inhibitor CT-1530 in patients with relapsed or refractory B cell non-Hodgkin lymphoma (B-NHL), chronic lymphocytic leukemia (CLL) or Waldenstrom's macroglobulinemia (WM).
The purpose of the study is to determine the MTD/RP2D of CT-1530, and evaluate its safety and tolerability as monotherapy in subjects with relapsed or refractory B cell non-Hodgkin lymphoma (B-NHL), chronic lymphocytic leukemia (CLL) or Waldenstrom's macroglobulinemia (WM).
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of B cell Non-Hodgkin Lymphoma(according to World Health Organization [WHO] classification)including Chronic Lymphocytic Leukemia/Small cell Lymphocytic Leukemia (International Workshop),or Waldenstrom's Macroglobulinemia(Second International Workshop).
- •Have failed ≥1 previous treatment for B-NHL/CLL/WM, and have relapsed or refractory disease following last prior treatment.
- •Eastern Cooperative Oncology Group performance status of ≤ 1 and a life expectancy of at least 3 months.
- •Measurable disease as per RECIST v1.1
- •Availability of tumor sample
- •Adequate hematologic function, as defined by neutrophils ≥ 1.0 x 10^9/L and platelets ≥ 50 x 10^9/L; patients with neutrophils < 1.0 x 10^9/L due to marrow infiltration are allowed to receive growth factors to bring pre-treatment neutrophils to ≥ 1.0 x 10^9/L.
- •Adequate renal function, as defined by creatinine clearance of ≥ 50 ml/min (as estimated by the Cockcroft-Gault equation or as measured by nuclear medicine scan or 24 hour urine collection).
- •Adequate liver function, as defined by AST and ALT ≤ 3 x ULN, and bilirubin ≤ 1.5 x ULN (unless documented Gilbert's syndrome).
排除标准
- •Prior allogeneic bone marrow transplant
- •Autologous stem cell transplant within 3 months of screening
- •Active central nervous system involvement
- •Subjects with autoimmune hemolytic anemia or immune thrombocytopenia
- •Prior treatment with a Btk inhibitor
- •Active uncontrolled infection
- •History of malabsorption
- •Uncontrolled illness, i.e cardiac, endocrine, respiratory, etc.
- •History of myocardial infarction, acute coronary syndromes, coronary angioplasty and/or stenting with in the previous 6 months
- •History of another currently active cancer
- •History of major surgery within 4 weeks or minor surgery within 1 week
- •Other medical or psychiatric illness or organ dysfunction
- •HIV positive
- •Positive for Hepatitis B surface antigen or Hepatitis C-virus
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
CT-1530
Experimental
干预措施: CT-1530 (Drug)
结局指标
主要结局
Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I)
时间窗: 28 days
Maximum Tolerated Dose(s) (MTD(s)) and/or recommended phase 2 dose (RP2D(s)) of CT-1530 in Subjects With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Mental-cell lymphoma, Diffuse large B-cell lymphoma, FL and Waldenstrom's Macroglobulinemia
次要结局
- Overall Response Rate (ORR) - Phase I(Up to 24 month)
- Progression free survival (PFS) per RECIST v1.1 - Phase I(Up to 24 months)
- Duration of response (DOR)(Up to 24 months)
研究者
研究点 (1)
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