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
- 68
- 试验地点
- 4
- 主要终点
- To determine the progression-free survival of the patients, defined as the proportion of patients who have not relapsed or died.
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. Enrolment in India started on 18, Feb 2009 with a total of 15 patients that are expected to be enrolled.
研究设计
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
入选标准
- •1.Patient's age is 18 years or older, both genders.
- •2.Confirmed Diffuse Large B-cell Lymphoma, transformed follicular lymphoma, diffuse mixed cell lymphoma or primary mediastinal large cell lymphoma with B-cell lineage.
- •3.The lymphoma is chemosensitive.
- •4.The lymphoma did not progress since pre-transplant chemotherapy.
- •5.ECOG performance status 0-1.
排除标准
- •1.Serious other illness.
- •2.Active autoimmune disease.
- •3.Type 1 diabetes.
- •4.Known immune deficiency.
- •5.Clinical evidence of primary or secondary brain or spinal cord involvement by lymphoma.
- •6.Active bacterial, fungal, or viral infection.
- •7.Positive HIV, Hepatitis B surface antigen plus viremia, or Hepatitis C antibody plus viremia.
- •8.Pregnant or nursing (positive pregnancy test).
- •9.Other concurrent clinical study or investigational therapy.
结局指标
主要结局
To determine the progression-free survival of the patients, defined as the proportion of patients who have not relapsed or died.
时间窗: Within 16 months following the first CT-011 treatment (18 months following autologous PBSCT). ] [Designated as safety issue: No]
次要结局
- 1.Evaluate the toxicity and safety of CT-011 in patients with DLBCL.2.Evaluate the event free survival (events are defined as relapse, second malignancy or death) in patients treated with CT-011.3.Evaluate the overall survival in patients treated with CT-011.(Within 18 months following autologous PBSCT.] [Designated as safety issue: Yes])