NCT01775631已完成1 期
A Phase 1b, Open-label, Multicenter Study of Urelumab (BMS-663513) in Combination With Rituximab in Subjects With Relapsed/Refractory B-cell Malignancies
Bristol-Myers Squibb29 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2013年3月最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 29
- 主要终点
- Safety and tolerability of Urelumab in combination with Rituximab as measured by incidence of adverse events (AEs), serious AEs, death, vital sign changes, electrocardiograms (ECGs), physical examination results, and laboratory test abnormalities
研究概览
简要总结
The purpose of the study is to determine the safety, tolerability and maximum tolerated dose of Urelumab in combination with Rituximab in patients with B-cell Non-Hodgkins Lymphoma
详细描述
Intervention model: Dose Escalation (part 1) of study= Sequential Design; Dose Expansion (part 2) of study= Parallel Design
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Clinical diagnosis of relapsed/refractory B-cell Malignancies (B-Non-Hodgkins Lymphoma (NHL)) per International Workshop Group (IWG)
- •Progressed or refractory to at least 1 prior line of standard therapy
- •Subjects in Expansion cohorts are restricted to relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or Follicular Lymphoma (FL) subjects who are either relapsed or refractory to prior rituximab or ritxumab-containing chemotherapy regimens
- •Follicular Lymphoma (FL) must have at least 1 lesion that can be biopsied at screening and on treatment
- •Eastern Cooperative Oncology Group (ECOG) of 0 to 1
排除标准
- •Active or progressing brain metastases
- •Other concomitant malignancies (with some exceptions per protocol)
- •Active or history of autoimmune disease
- •Positive test for human immunodeficiency virus (HIV) 1&2 or known Acquired immune deficiency syndrome (AIDS)
- •History of any hepatitis (A, B or C)
- •History of grade 3-4 drug-related hepatitis
- •Known current drug or alcohol abuse
- •Active tuberculosis (TB)
- •Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti-CD137, Anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA4) or Anti-Glucocorticoid-induced tumor necrosis factor receptor (anti-GITR). However, Anti-Programmed Death-1 (anti-PD-1), Anti-Programmed Death-Ligand1 (anti-PD-L1) are permissible as prior therapy
结局指标
主要结局
Safety and tolerability of Urelumab in combination with Rituximab as measured by incidence of adverse events (AEs), serious AEs, death, vital sign changes, electrocardiograms (ECGs), physical examination results, and laboratory test abnormalities
时间窗: Up to 110 days after last dose of Rituximab
次要结局
- Trough observed serum concentration (Cmin) of Urelumab and Rituximab(12 + 9 time points up to Day 60 of Follow-up)
- Area under the concentration-time curve (AUC) in one dosing interval (AUC(TAU)) of Urelumab(12 time points up to Day 60 of Follow-up)
- Maximum observed serum concentration (Cmax) of Urelumab and Rituximab(12 time points up to Day 60 of Follow-up)
- Efficacy-Antitumor Activity of Urelumab in combination with Rituximab as measured by best overall response, progression-free survival, time to response, and duration of response(Up to approximately 3 years)
- Time of maximum observed serum concentration (Tmax) of Urelumab(12 time points up to Day 60 of Follow-up)
- Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Urelumab(12 time points up to Day 60 of Follow-up)
- Immunogenicity of Urelumab in combination with Rituximab as determined by blood sample measurements of anti-drug antibodies (ADA)(Up to approximately 110 days post study drug)
研究者
研究点 (29)
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