Open Label, Multi-center, Phase IV Study of Ruxolitinib or Ruxolitinib and Panobinostat Combination, for Patients Who Have Completed Prior Global Novartis or Incyte Sponsored Studies
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 279
- 试验地点
- 100
- 主要终点
- Incidence and severity of AEs and SAEs
研究概览
简要总结
This is a long term safety study for patients that have been treated with either ruxolitinib or a combination of ruxolitinib with panobinostat, on a Novartis or Incyte sponsored study, who have been judged by the study Investigator to benefit from ongoing treatment.
详细描述
This roll-over protocol allows patients from multiple protocols, who are still receiving clinical benefit, to continue their treatment in one study that covers multiple indications. The population for the roll-over study should be consistent with the population defined in the parent studies. The primary eligibility criteria for a patient to enter the roll-over protocol is the participation and completion of a Novartis or Incyte study with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat. Efficacy parameters will not be measured; however safety data and an evaluation of clinical benefit will be collected.
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
- 1 Month 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is currently enrolled in a Novartis GDD or GMA-sponsored or Incyte-sponsored clinical study, are receiving either ruxolitinib or combination of ruxolitinib and panobinostat, and fulfilled all of the requirements of the parent protocol.
- •Patient is currently benefiting from the treatment with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat, as determined by the investigator
- •Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements
- •Patient currently has no evidence of progressive disease, as determined by the investigator, following previous treatment with ruxolitinib or combination of ruxolitinib and panobinostat
排除标准
- •Patient has been permanently discontinued from study treatment in the 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 and panobinostat.
- •Pregnant or nursing (lactating) women.
- •Female patients of childbearing potential (e.g. are menstruating) who do not agree to abstinence or, if sexually active, do not agree to the use of highly effective contraception, throughout the study and for up to 30 days after stopping study treatment.
- •Other protocol-defined Inclusion / Exclusion criteria may apply.
研究组 & 干预措施
Ruxolitinib monotherapy or ruxolitinib plus panobinostat in combination
All participants will receive either ruxolitinib monotherapy or ruxolitinib in combination with panobinostat, at the same dose/schedule that they were taking in the parent study.
干预措施: ruxolitinib (Drug)
Ruxolitinib monotherapy or ruxolitinib plus panobinostat in combination
All participants will receive either ruxolitinib monotherapy or ruxolitinib in combination with panobinostat, at the same dose/schedule that they were taking in the parent study.
干预措施: panobinostat (Drug)
结局指标
主要结局
Incidence and severity of AEs and SAEs
时间窗: 12 years
The incidence of treatment-emergent AEs and SAEs (new or worsening from baseline) will be summarized by system organ class and/or preferred term, severity (based on CTCAE grades).
次要结局
- Proportion of participants with clinical benefit as assessed by the investigator at scheduled visits.(12 years)
- Incidence and severity of AEs and SAEs by treatment group(12 years)
- Percentage of participants with clinical benefit as assessed by the investigator at scheduled visits.(12 years)