Two-arm Phase II Trial Exploring the Use of the Targeted Agents Ibrutinib and Obinutuzumab for the Treatment of Patients With a Diagnosis of Richter's Transformation (RT) or Richter's Syndrome (RS)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This research study studies the combination of ibrutinib and obinutuzumab with or without the standard chemotherapy regimen of CHOP to see how well these drugs work in treating patients with a diagnosis of Richter's Transformation or Richter's Syndrome. The Bruton's Tyrosine Kinase (BTK) inhibitor, ibrutinib, may stop growth of cancer cells by blocking the signal needed for cell growth. The monoclonal antibody obinutuzumab may block cancer growth by targeting cells present in Richter's Transformation. Giving ibrutinib with obinutuzumab may be a better treatment for patients with Richter's Transformation. Depending on fitness, the patients may receive ibrutinib and obinutuzumab in combination with a regimen known as CHOP (C= cyclophosphamide, H= hydroxydaunorubicin (also called doxorubicin), O= oncovin (also called vincristine, and P= prednisolone or prednisone (corticosteroids).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed Richter's transformation in treatment naïve and previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma patients
- •may have had prior exposure to ibrutinib and other B-cell signaling receptor agents
- •Adequate hematologic function
- •Adequate liver and kidney function
- •Willing and able to participate in all required evaluations and procedures in this study protocol
- •Female subjects of childbearing potential must not be pregnant upon study entry
- •Male and female subjects who agree to use highly effective methods of birth control
排除标准
- •known allergy to any of medications
- •chemotherapy taken within 21 days of study treatment
- •targeted therapy within 10 days of study treatment
- •BCR inhibitors within 24 hours of study treatment
- •major surgery within 4 weeks of first dose of study treatment
- •women who are pregnant
- •known infection with HIV or Hepatitis C
- •Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug
研究组 & 干预措施
Fit arm
ibrutinib and obinutuzumab in combination with the CHOP regimen
干预措施: Obinutuzumab (Drug)
Fit arm
ibrutinib and obinutuzumab in combination with the CHOP regimen
干预措施: Ibrutinib (Drug)
Fit arm
ibrutinib and obinutuzumab in combination with the CHOP regimen
干预措施: CHOP (Other)
Frail arm
ibrutinib and obinutuzumab
干预措施: Obinutuzumab (Drug)
Frail arm
ibrutinib and obinutuzumab
干预措施: Ibrutinib (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 6 months
ORR in subjects treated with combination of ibrutinib and obinutuzumab (with or without CHOP)
次要结局
- Progression Free Survival (PFS)(6 months)
- To Evaluate Patient-reported Outcome (PRO) of Health-related Quality of Life by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACiT-Fatigue)(1 year)
- Number of Participants With Improved Hemoglobin and Platelet Counts.(6 months)