NCT04878003招募中2 期
An Open-Label, Multicenter, Phase 2 Study Assessing the Safety and Efficacy of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 28
- 主要终点
- Spleen Volume Reduction (SVR)
研究概览
简要总结
This study evaluates either KRT-232 or TL-895 in treatment naïve patients with myelofibrosis (MF)
The study will be conducted in 2 stages. Stage 1 will evaluate safety, tolerability, and efficacy of either KRT-232 (Arm 1) or TL-895 (Arm 2) in treatment naïve patients. Stage 2 will expand enrollment in Arm 1 and/or Arm 2 if expansion criteria is met.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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, post-PV MF or post-ET MF (WHO)
- •High-risk, or intermediate-1 and 2 risk, defined by Dynamic International Prognostic System (DIPSS)
- •ECOG of 0 or 1
排除标准
- •Subjects who are positive for p53 mutation (Arm 1)
- •Prior MDM2 inhibitor therapy or p53-directed therapy (Arm 1)
- •Prior treatment with any JAK inhibitor
- •Prior splenectomy
- •Splenic irradiation within 24 weeks prior to randomization
- •Prior allogeneic stem-cell transplantation or plans for allogeneic stem-cell transplant
- •History of major organ transplant
- •Grade 2 or higher QTc prolongation
- •Major hemorrhage or intracranial hemorrhage within 24 weeks prior to randomization
研究组 & 干预措施
Arm 1
Experimental
KRT-232 administered orally as 240 mg once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles
干预措施: KRT-232 (Drug)
Arm 2
Experimental
TL-895 administered orally as 150 mg twice daily continuously in 28-day cycles
干预措施: TL-895 (Drug)
结局指标
主要结局
Spleen Volume Reduction (SVR)
时间窗: 24 weeks
The proportion of subjects achieving ≥35% SVR at Week 24 by MRI/CT (central review)
次要结局
- Spleen Response Duration(48 months)
- Rate of conversion from RBC transfusion dependent to independent(24 weeks)
- Progression free survival (PFS)(48 months)
- Improvement in Total Symptom Score (TSS)(24 weeks)
- Overall Survival (OS)(48 months)
研究者
研究点 (28)
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