NCT05688475进行中（未招募）1 期
Continuing Treatment for Participants Who Have Participated in a Prior Protocol Investigating CC-122
Bristol-Myers Squibb14 个研究点 分布在 4 个国家目标入组 12 人开始时间: 2023年4月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
- 试验地点
- 14
- 主要终点
- Number of participants with serious adverse events (SAEs) for participants who received at least 1 dose of CC-122
研究概览
简要总结
The purpose of the study is to provide CC-122 treatment to participants who have been receiving treatment in other CC-122 clinical trials investigating CC-122 for more than 5 years (CC-122-ST-001 [NCT01421524], CC-122-ST-002 [NCT02509039], CC-122-DBCL-001 [NCT02031419], and CC-122-NHL-001 [NCT02417285]), receiving clinical benefit from the treatment and to monitor the safety and tolerability of CC-122.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Participant who is currently receiving CC-122 on another CC-122 clinical trial that has met its primary and secondary endpoints.
- •Participant who has participated in previous CC-122 protocol (including CC-122-ST-001 [NCT01421524], CC-122-ST-002 [NCT02509039], CC-122-DBCL-001 [NCT02031419], and CC-122-NHL-001 [NCT02417285]), and is deemed by the investigator to be deriving benefit from CC-122 as defined by the previous protocol.
- •Participant who is able to tolerate study therapy and has not yet experienced progressive disease or any treatment discontinuation criteria of the Parent Study.
排除标准
- •Participant is not eligible for CC-122 treatment as per the Parent Study.
- •Participants not receiving clinical benefit as assessed by the investigator. Any clinical AE, laboratory abnormality, or intercurrent illness which, in the opinion of the investigator, indicates that participation in the study is not in the best interest of the participant.
- •Women who are breastfeeding.
- •Note: Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
CC-122 and Dexamethasone
Experimental
干预措施: Dexamethasone (Drug)
CC-122 and Dexamethasone
Experimental
干预措施: CC-122 (Drug)
结局指标
主要结局
Number of participants with serious adverse events (SAEs) for participants who received at least 1 dose of CC-122
时间窗: Up to approximately 3 years
Number of deaths for participants who received at least 1 dose of CC-122
时间窗: Up to approximately 3 years
次要结局
未报告次要终点
研究者
研究点 (14)
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