临床试验/NCT01534715

NCT01534715已完成1 期

A Phase I, Multi-center, Open-label Study of IMGN529 Administered Intravenously in Adult Patients With Relapsed or Refractory Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

ImmunoGen, Inc.7 个研究点分布在 2 个国家目标入组 49 人开始时间: 2012年1月最近更新: 2017年12月29日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: ImmunoGen, Inc.
入组人数: 49
试验地点: 7
主要终点: Occurrence of dose limiting toxicities

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to test the safety and tolerability of IMGN529 in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL).

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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Relapsed or refractory NHL including tumor types: Follicular lymphoma (FL), marginal zone lymphoma (MZL)/mucosa-associated lymphoid tissue (MALT), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL).
•Adequate organ function
•Recovered or stabilized from prior treatments.

排除标准

•Allogeneic stem cell transplantation
•Pregnant or lactating females
•Known central nervous system, meningeal or epidural disease including brain metastases

研究组 & 干预措施

IMGN529

Experimental

Dose escalation study, dosing done every 3 weeks.

干预措施: IMGN529 (Drug)

结局指标

主要结局

Occurrence of dose limiting toxicities

时间窗: During study

次要结局

未报告次要终点

研究者

发起方

ImmunoGen, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (7)

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