An International, Phase 2, Open-Label, Efficacy and Safety Study of MDV9300 in Patients With an Incomplete Response Following Salvage Therapy or Autologous Stem Cell Transplantation for Relapsed or Refractory CD20+ Diffuse Large B-Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Best overall response rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of MDV9300 in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that have achieved either stable disease or a partial remission following definitive salvage therapy.
Two cohorts of patients will be enrolled: a cohort treated with salvage chemotherapy but considered ineligible for autologous stem cell transplant (ASCT), and a cohort of patients who have received ASCT following salvage chemotherapy.
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
- •Age 18 years or older and willing and able to provide informed consent;
- •Histologically confirmed relapsed or refractory CD20+ DLBCL, transformed indolent lymphoma (follicular or other), or primary mediastinal large B-cell lymphoma;
- •Received prior treatment with a standard anthracycline and therapeutic anti-CD20 monoclonal antibody-based regimen;
- •For transplant-ineligible patients, salvage therapy just prior to MDV9300 treatment must have resulted in a PR or stable disease;
- •For post autologous stem cell transplant (ASCT) patients, salvage therapy plus ASCT just prior to MDV9300 treatment must have resulted in a PR or stable disease;
- •Adequate bone marrow reserve as defined per protocol;
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Patients with stable ECOG scores of 2 may be allowed with medical monitor approval.
排除标准
- •Burkitt, mantle cell, follicular, or mucosa-associated lymphoid tissue lymphoma
- •History of serious autoimmune disease;
- •History of central nervous system involvement of lymphoma;
- •Prior therapy with agents targeting immune coinhibitory receptors.
结局指标
主要结局
Best overall response rate
时间窗: no later than 6 months after the last patient is enrolled in a cohort
Defined as the proportion of patients in the intent-to-treat population with a complete response (CR) or partial response (PR) attributable to study treatment, as assessed by the independent review committee (IRC).
次要结局
- Duration of response (for responders)(no later than 6 months after the last patient is enrolled in a cohort)
- Progression-free survival(no later than 6 months after the last patient is enrolled in a cohort)
- Time to response (for responders)(no later than 6 months after the last patient is enrolled in a cohort)
- Overall survival(no later than 6 months after the last patient is enrolled in a cohort)
- Composite of safety(no later than 6 months after the last patient is enrolled in a cohort)