Phase II Trial of Ibrutinib and PD-1 Blockade in High Risk Chronic Lymphocytic Leukemia to Improve Immune Dysfunction
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR) to the Therapeutic Intervention
研究概览
简要总结
The purpose of this study is to evaluate the impact of sequential overlapping treatment with PD-1 monoclonal antibody (mAb), pembrolizumab/MK-1375, followed by ibrutinib on endogenous immune function in previously untreated, high-risk CLL patients. Immune function will be evaluated through various laboratory correlative tests.
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
- •Have high risk CLL
- •Have documented previously untreated CLL according to IWCLL criteria
- •Willing and able to provide written informed consent
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Demonstrate adequate organ function
- •Able to take oral medication and willing to adhere to the medication regimen
排除标准
- •Currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment
- •Meets IWCLL criteria to start therapy
- •Has had any treatment for CLL including any investigational agent, chemotherapy, mAb, anti-PD-1, anti-PDL-1, or anti-CTLA-4
- •Transformation of CLL to aggressive NHL (Richter's transformation or pro-lymphocytic leukemia)
- •Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- •Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 90 days after the last dose of trial treatment
- •Major surgery or a wound that has not fully healed within 4 weeks of first dose
- •Additional criteria may apply
研究组 & 干预措施
Pembrolizumab and Ibrutinib
Treatment with pembrolizumab and ibrutinib and follow-up period of up to 24 months.
Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
Ibrutinib is an inhibitor of Bruton's tyrosine kinase (BTK). Ibrutinib is a small-molecule inhibitor of BTK.
干预措施: Pembrolizumab (Drug)
Pembrolizumab and Ibrutinib
Treatment with pembrolizumab and ibrutinib and follow-up period of up to 24 months.
Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
Ibrutinib is an inhibitor of Bruton's tyrosine kinase (BTK). Ibrutinib is a small-molecule inhibitor of BTK.
干预措施: Ibrutinib (Drug)
结局指标
主要结局
Overall Response Rate (ORR) to the Therapeutic Intervention
时间窗: Up to 2 years
Response categories according to The International Workshop on Chronic Lymphocytic Leukemia (IWCLL): Complete remission (CR); Complete remission with incomplete marrow recovery (CRi); Partial remission (PR); Progressive disease (PD); Stable disease (SD), defined as not meeting criteria for CR, CRi, PR or PD.
Time to Best Response
时间窗: Up to 2 years
Time to best response to chronic lymphocytic leukemia (CLL) to the therapeutic intervention.
次要结局
- Progression-free Survival (PFS)(Up to 2 years)