A Randomized Phase 2 Study of SCH 727965 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL) or B-Cell Chronic Lymphocytic Leukemia (B-CLL)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 主要终点
- Response rate of initial treatment with SCH 727965 in subjects with MCL or B-CLL.
研究概览
简要总结
Participants will be randomized to SCH 727965 or a comparator drug (bortezomib for mantle cell lymphoma [MCL] or alemtuzumab for B cell chronic lymphocytic leukemia [B CLL]). Part 1 of the study will determine the activity of SCH 727965 treatment in participants with MCL and participants with B-CLL. Part 2 of the study will determine the activity of SCH 727965 treatment in participants who experienced disease progression after standard treatment with the comparator drug during Part 1.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >=18 years, either sex, any race.
- •Eastern Cooperative Oncology group performance status of 0 or
- •Adequate hematologic, renal, and hepatic organ function and laboratory parameters.
- •For subjects with MCL:
- •Diagnosis of MCL according to the World Health Organization (WHO) criteria.
- •Received at least one prior chemotherapeutic regimen, but no more than two regimens including stem cell transplantation..
- •Measurable or assessable disease by the Revised Response Criteria for Malignant Lymphoma.
- •For subjects with B-CLL
- •Documented B-CLL according to the National Cancer Institute Working Group (NCI-WG) criteria.
- •Received at least one prior alkylating agent-based regimen and one fludarabine- or pentostatin-containing regimen, but must not have received more than two prior regimens.
- •Measurable or assessable disease by NCI-WG criteria.
排除标准
- •Known central nervous system involvement of MCL or B-CLL.
- •Previous treatment with SCH 727965 or other cyclin-dependent kinase inhibitors.
- •For MCL, previous treatment with bortezomib.
- •For B-CLL, previous treatment with alemtuzumab.
- •Known HIV infection.
- •Known active hepatitis B or C.
研究组 & 干预措施
Participants with MCL randomized to SCH 727965
干预措施: SCH 727965 (Drug)
Participants with MCL randomized to bortezomib
干预措施: Bortezomib (Drug)
MCL treated w/SCH 727965 after progression on bortezomib
干预措施: SCH 727965 (Drug)
Participants with B-CLL randomized to SCH 727965
干预措施: SCH 727965 (Drug)
Participants with B-CLL randomized to alemtuzumab
干预措施: Alemtuzumab (Biological)
B-CLL treated w/ SCH 727965 after progression on alemtuzumab
干预措施: SCH 727965 (Drug)
结局指标
主要结局
Response rate of initial treatment with SCH 727965 in subjects with MCL or B-CLL.
时间窗: Time to identified disease progression on SCH 727965 in Part 1 (approx. 6 months)
Response rate in subjects treated with SCH 727965 after disease progression on comparator drug.
时间窗: Time to identified disease progression on SCH 727965 in Part 2 (approx. 6 months)
次要结局
- Time to disease progression and response rate for treatment with the comparator drug.(Time to identified disease progression on comparator drug (bortezomib for MCL or alemtuzumab for B-CLL).)
- Time to disease progression for initial treatment with SCH 727965.(Time to identified disease progression on SCH 727965 in Part 1 (approx. 6 months))
- Response rate for treatment with the comparator drug.(Time to identified disease progression on comparator drug (bortezomib for MCL or alemtuzumab for B-CLL).)
- Time to disease progression in participants treated with SCH 727965 after disease progression on comparator drug.(Time to identified disease progression on SCH 727965 in Part 2 (approx. 6 months))