NCT02091752终止2 期
The ReTreatment Trial: A Phase II, Open-label, Single-arm Study of Re-treating Myelofibrosis Patients With Ruxolitinib/Jakavi After Treatment Interruption Due to Loss of Response and/or Adverse Event.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Proportion of Patients Achieving ≥20% Reduction From Baseline in Spleen Volume
研究概览
简要总结
The aim of the study is to assess the efficacy and safety of restarting ruxolitinib after treatment interruption due to loss of response and/or adverse events.
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
- •Confirmed diagnosis of PMF, PPV MF or PET-MF, irrespective of JAK2 mutational status according to the 2008 revised International Standard Criteria
- •Peripheral blast count < 10%
- •Requires therapy for MF in the opinion of the investigator
- •Received prior monotherapy treatment with ruxolitinib for at least 12 consecutive weeks and experienced treatment interruption because of lossof response or adverse event
- •Patients adhering to the Screening phase assessments and undergoing a a ruxolitinib-free washout period of a minimum of 1 week and a maximum of 8 weeks
- •ECOG performance status 0, 1, 2, or 3
- •Adequate bone marrow function
- •Written informed consent
排除标准
- •Patients not initially responding (primary resistance) to ruxolitinib therapy
- •Patients who underwent a splenectomy or spleen radiation
- •Patients currently scheduled for bone marrow transplant
- •Patients who have discontinued ruxolitinib < 14 days prior to screening
- •Patients who are not able to receive a starting dose of ruxolitinib of at least 15 mg total daily dose
- •Leukemic transformation
- •Inadequate renal function
- •Presence of clinically meaningful active bacterial, fungal, parasitic or viral infection which requires therapy
- •Previous history of Progressive Multifocal Leuko-encephalopathy (PML)
- •Clinically significant cardiac disease or significant concurrent medical condition
研究组 & 干预措施
Ruxolitinib
Experimental
All participants received ruxolitinib.
干预措施: Ruxolitinib (Drug)
结局指标
主要结局
Proportion of Patients Achieving ≥20% Reduction From Baseline in Spleen Volume
时间窗: Week 24
次要结局
- Proportion of Patients Achieving ≥25% and ≥50% Reduction, Respectively From Baseline, in Spleen Length(Week 24)
- Patient Global Impression of Change (PGIC) Score(Week 1, Week 24)
- Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and EuroQol (EQ)-5D-5L Scores(Baseline, Day 1, Week 8, Week 12, Week 16, Week 24)
- Change From Baseline in MPN-SAF TSS Score(Baseline, Week 24)
- Proportion of Patients Achieving ≥35% Reduction From Baseline in Spleen Volume(Week 24)
- Change From Baseline in Spleen Length and Spleen Volume(Baseline, Week 24)
- Proportion of Patients Achieving ≥25% and ≥50% Reduction, Respectively, From Baseline in Total Symptom Score (MPN-SAF TSS)(Week 24)
研究者
研究点 (1)
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