A Phase 2 Study of the Safety and Efficacy of Venetoclax in Combination With Obinutuzumab or Ibrutinib in Japanese Subjects With Previously Untreated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 20
- 主要终点
- Complete Remission (CR) with an Incomplete Marrow Recovery (CRi) Rate, as Assessed by an Independent Review Committee (IRC) per Modified 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) for Venetoclax + Obinutuzumab (V+G)
研究概览
简要总结
Chronic lymphocytic leukemia (CLL) is the most common leukemia in Western countries, representing approximately 30% of all adult leukemias. There is a large difference in proportion of malignant lymphoma between the United States (US) and Japan was seen in CLL/small lymphocytic lymphoma (SLL) (Japan, 3.2%; US, 24.1%). The purpose of this study is to assess how well venetoclax works in combination with obinutuzumab (V+G, Cohort 1) or with ibrutinib (V+I, Cohort 2) in Japanese participants with previously untreated CLL/Small Lymphocytic Lymphoma (SLL). Adverse events and change in disease activity will be assessed.
Venetoclax is an approved drug for the treatment of CLL and SLL. Study doctors put the participants in 1 of 2 groups, called treatment arms, based on variable alternating assignment. Approximately 20 adult participants with previously untreated CLL/SLL will be enrolled in the study in approximately 20 sites in Japan.
Participants in group 1 will receive oral venetoclax + intravenous (IV) obinutuzumab (V+G) in 28-day cycles for a total of 12 cycles, and participants in group 2 will receive oral venetoclax + oral ibrutinib (V+I) in 28-day cycles for a total of 15 cycles.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or female, at least ≥ 65 years old; or 20 to 64 years old and have at least 1 of the following:
- •Cumulative Illness Rating Scale (CIRS) score >
- •Creatinine clearance (CrCl) estimated < 70 mL/min using Cockcroft-Gault equation.
- •Must have measurable nodal disease (by computed tomography [CT]), defined as at least one lymph node > 1.5 cm in longest diameter.
- •Diagnosed Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) that requires treatment according to the Modified 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.
排除标准
- •Transformation of Chronic Lymphocytic Leukemia (CLL) to aggressive non-Hodgkin lymphoma (NHL; Richter's transformation or pro-lymphocytic leukemia).
- •Previous treatment history for CLL/SLL.
研究组 & 干预措施
Venetoclax + Obinutuzumab (V+G)
Participants will receive venetoclax + obinutuzumab for twelve 28-day cycles.
干预措施: Venetoclax (Drug)
Venetoclax + Obinutuzumab (V+G)
Participants will receive venetoclax + obinutuzumab for twelve 28-day cycles.
干预措施: Obinutuzumab (Drug)
Venetoclax + Ibrutinib (V+I)
Participants will receive venetoclax + ibrutinib for fifteen 28-day cycles.
干预措施: Venetoclax (Drug)
Venetoclax + Ibrutinib (V+I)
Participants will receive venetoclax + ibrutinib for fifteen 28-day cycles.
干预措施: Ibrutinib (Drug)
结局指标
主要结局
Complete Remission (CR) with an Incomplete Marrow Recovery (CRi) Rate, as Assessed by an Independent Review Committee (IRC) per Modified 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) for Venetoclax + Obinutuzumab (V+G)
时间窗: Up to Week 32
CR rate is defined as the percentage of participants achieving a best response of CR or CRi.
CR/CRi Rate, as Assessed by an IRC per iwCLL for Venetoclax + Ibrutinib (V+I)
时间窗: Up to Week 56
CR rate is defined as the percentage of participants achieving a best response of CR or CRi.
次要结局
- CR/CRi Rate, as Assessed by an Investigator per iwCLL for (V+G)(Up to Week 32)
- CR/CRi Rate, as Assessed by an Investigator per iwCLL for (V+I)(Up to Week 56)
- Overall response rate (ORR) as Assessed by IRC for (V+G)(Up to Week 32)
- ORR as Assessed by IRC (V+I)(Up to Week 56)
- Progression-Free Survival (PFS) as Assessed by IRC for (V+G)(Up to Week 32)
- DOR as Assessed by IRC for (V+I)(Up to Week 56)
- TTP as Assessed by Investigator for (V+I)(Up to Week 56)
- ORR as Assessed by Investigator for (V+G)(Up to Week 32)
- Duration of response (DOR) as Assessed by IRC for (V+G)(Up to Week 32)
- DOR as Assessed by Investigator for (V+G)(Up to Week 32)
- DOR as Assessed by Investigator for (V+I)(Up to Week 56)
- Overall Survival (OS) for (V+G)(Up to Week 32)
- OS for (V+I)(Up to Week 56)
- Time to progression (TTP) as Assessed by IRC for (V+G)(Up to Week 32)
- TTP as Assessed by IRC for (V+I)(Up to Week 56)
- ORR Assessed by Investigator + Ibrutinib (V+I)(Up to Week 56)
- TTP as Assessed by Investigator for (V+G)(Up to Week 32)
- PFS as Assessed by IRC for (V+I)(Up to Week 56)
- PFS as Assessed by Investigator for (V+G)(Up to Week 32)
- PFS as Assessed by Investigator for (V+I)(Up to Week 56)