NL-OMON49694已完成不适用
A Phase 1b Open Label Study Investigating the Safety and Efficacy of Blinatumomab in combination with Pembrolizumab in Adult Subjects with Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL) - 20150290
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •This study seeks to enroll adult subjects with histologically confirmed Diffuse
- •Large B Cell Lymphoma that is either:
- •-refractory after at least one regimen of systemic chemotherapy and/or targeted
- •therapy, and refractory is defined as progressive or stable disease as the best
- •response to the most recent systemic chemotherapy regimen or disease
- •progression or relapse within 12 months after autologous stem cell
- •transplantation; when using PET for assessment, for subjects with refractory
- •disease and who have received radiotherapy, PET positivity should be
- •demonstrated no less than 6 weeks after the last dose of radiotherapy (Crump et
- •al, 2017; Neelapu et al, 2017; Cheson et al, 2007), or
- •-in first or later relapse if have received at least 2 systemic regimens since
- •time of diagnosis, or
- •-relapsed post autologous or allogeneic HSCT with adequate organ function after
- •proximity to transplantation time exclusions as specified in Exclusion Criteria
- •208 and 209.
- •For a full list of eligibility criteria, please refer to Section 4.1 and
- •Section 4.2
排除标准
- •Subjects will be excluded if they have Richter's transformation (DLBCL arising
- •in the setting of
- •prior chronic lymphocytic leukemia) or Primary Mediastinal B cell Lymphoma
- •(PMBCL) or have
- •history or presence of clinically relevant central nervous system (CNS)
- •pathology such as
- •epilepsy, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson*s
- •disease, cerebellar disease, organic brain syndrome, or psychosis or has
- •evidence of active, non-infectious
- •pneumonitis, or has a history of interstitial lung disease.
- •For a full list of eligibility criteria, please refer to Section 4.1 and
- •Section 4.2
研究者
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