Phase II Safety and Efficacy Study of the Monoclonal Antibody CT-011 in Patients With Diffuse Large B-Cell Lymphoma Following Autologous Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- CureTech Ltd
- 入组人数
- 72
- 试验地点
- 27
- 主要终点
- Progression-free Survival
研究概览
简要总结
Autologous peripheral blood stem cell transplantation combined with high dose chemotherapy is the treatment of choice given to patients with diffuse large-B cell lymphoma (DLBCL) following relapse of the disease. Although many people are cured of their lymphoma with this therapy, the disease comes back in a certain proportion of patients. The purpose of this study is to test the safety and effectiveness of the monoclonal antibody, CT-011, in patients with DLBCL who have received autologous peripheral blood stem cell transplantation. All final eligible patients will receive an IV infusion of CT-011 on Day 1 (30 to 90 days post autologous PBSCT). Treatment will be repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85. Follow-up for safety and clinical outcome will be conducted throughout the study till 18 months post autologous PBSCT. Approximately 70 patients will participate in this study.
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
- •Patient's age is 18 years or older, both genders.
- •Confirmed Diffuse Large B-cell Lymphoma, transformed follicular lymphoma, diffuse mixed cell lymphoma or primary mediastinal large cell lymphoma with B-cell lineage.
- •The lymphoma is chemosensitive.
- •The lymphoma did not progress since pre-transplant chemotherapy.
- •ECOG performance status 0-1.
排除标准
- •Serious other illness.
- •Active autoimmune disease.
- •Type 1 diabetes.
- •Known immune deficiency.
- •Clinical evidence of primary or secondary brain or spinal cord involvement by lymphoma.
- •Active bacterial, fungal, or viral infection.
- •Positive HIV, Hepatitis B surface antigen plus viremia, or Hepatitis C antibody plus viremia.
- •Pregnant or nursing (positive pregnancy test).
- •Other concurrent clinical study or investigational therapy.
研究组 & 干预措施
CT-011
The monoclonal antibody termed CT-011 (currently, pidilizumab).
干预措施: CT-011 (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: 16 months following the first CT-011 administration (approximately 18 months following autologous PBSCT).
PFS (progression-free survival ) will be determined at the eligible patient populations
次要结局
- Overall Survival(within 16 months following the first CT-011 treatment (18 months following autologous PBSCT).)