A Long-term, Continued Treatment and Follow-up Study in Subjects With Hematologic Malignancies Treated With Duvelisib (IPI-145)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
This was a long-term, continued treatment study that evaluated the long-term safety, clinical activity, and overall survival (OS) of duvelisib in individuals with hematologic malignancies that were previously treated with duvelisib in a previous sponsor-approved study.
详细描述
Study IPI-145-23 was an international, multicenter, open-label, single-arm, Phase 2 study designed to evaluate the long-term safety, clinical activity, and overall survival data of duvelisib in individuals with hematologic malignancies. Only individuals who have participated in a previous duvelisib study that were approved by the sponsor were allowed to enroll in the study.
Participants in active treatment and participants in survival follow-up were allowed to rollover to this study. For participants on active treatment, participants continued the same dose from their previous duvelisib study administered twice daily for 28-day continuous cycles until disease progression or unacceptable toxicity and then followed in a survival follow-up period. For participants in survival follow-up, participants continued to be followed-up for survival in this study for the duration as outlined in their previous duvelisib study.
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 participated in a previous study of duvelisib, and:
- •Be actively receiving duvelisib monotherapy on the previous study (within 14 days of study entry) and demonstrating clinical benefit (complete response [CR]/ partial response [PR]/ stable disease [SD]) of continued use, or
- •Be in the survival follow-up phase of a previous duvelisib study
- •Have completed the required components of the previous study and be appropriate for enrollment into this long-term continued treatment and follow-up study, as determined by the Sponsor
排除标准
- •Had any ongoing ≥ Grade 3 adverse event (AE) considered related to duvelisib treatment at screening
- •Was pregnant or nursing
研究组 & 干预措施
Duvelisib
Participants received the same dose from their previous duvelisib study. All doses were taken twice daily. Two dose reductions were allowed per participant, but doses were not less than 10 milligrams (mg). Participants received duvelisib until disease progression or unacceptable toxicity.
干预措施: Duvelisib (Drug)
结局指标
主要结局
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to 45 months
A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
次要结局
- Overall Survival (OS)(Up to 45 months)
- Best Overall Response (BOR) to Duvelisib as Assessed by the Investigator(Up to 45 months)