2024-515283-31-00招募中4 期
An open label, multi-center, Phase IV rollover protocol for patients who have completed a prior global Novartis or Incyte sponsored ruxolitinib (INC424) study or a study of ruxolitinib in combination with either panobinostat (LBH589) or siremadlin (HDM201) or rineterkib (LTT462), and are judged by the investigator to benefit from continued treatment
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 33
- 试验地点
- 15
- 主要终点
- Frequency and severity of SAEs/AEs
研究概览
简要总结
To evaluate long term safety data, i.e. SAEs and AEs
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Patient is currently enrolled in a Novartis-sponsored GDD or GMA study or Incyte-sponsored study (where Incyte can delegate the sponsorship to a preferred CRO, if applicable) and are receiving either ruxolitinib or combination of ruxolitinib and panobinostat, or combinations of ruxolitinib and siremadlin, or ruxolitinib and rineterkib and fulfilled all the requirements of the parent protocol. Please refer to the list of parent studies in Appendix
- •Patient is currently benefitting from the treatment with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat, or combinations of ruxolitinib and siremadlin or ruxolitinib and rineterkib as determined by the investigator.
排除标准
- •Patient has been permanently discontinued from study treatment in parent study due to any reason.
- •Patient’s indication is currently approved and reimbursed in the corresponding country for ruxolitinib monotherapy or combination of ruxolitinib with panobinostat, or ruxolitinib and siremadlin or ruxolitinib and rineterkib (if the patient is receiving combination treatment in the parent study).
结局指标
主要结局
Frequency and severity of SAEs/AEs
Frequency and severity of SAEs/AEs
次要结局
- Proportion of patients with clinical benefit as assessed by the investigator at scheduled visits
- Frequency and severity of AEs / SAEs
- Proportion of patients with clinical benefit and assessed by the investigators at scheduled visits
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (15)
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