CTIS2024-514467-26-00进行中（未招募）1 期
A Phase 2 Multicenter Study of TL-895 in Subjects with Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis, Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis, or Indolent Systemic Mastocytosis - TL-895-201
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 231
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Cohorts 1-3: Adults =18 years of age, Cohorts 1-3: Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria, Cohorts 1-3: Eastern Cooperative Oncology Group (ECOG) performance status of =2, Cohorts 1-3: Adequate hematologic, hepatic, and renal functions, Cohorts 1-3: MF symptoms as defined by having at least 2 symptoms with an average baseline (Day -7 to Day -1) score of at least 1 for each of the 2 symptoms per MFSAF v4.0, Cohort 3 only: Ineligibility for JAKi treatment with a platelet count of = 25 and < 50 x 10^9/L, Cohort 5: Confirmed diagnosis of ISM as defined by WHO diagnostic criteria based on review of bone marrow biopsy pathology report results, Cohort 5: Subject must have moderate-to-severe symptoms
排除标准
- •Cohorts 1-3, 5: Prior treatment with any BTK or BMX inhibitors, Cohorts 1-3: Prior treatment with JAKi within 28 days prior to study treatment, Cohorts 1-3: Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment, Cohort 5: Prior treatment with Avapritinib, bezuclastinib, or BLU-263/elenestinib, Cohort 5: Diagnosis with another myeloproliferative disorder
研究者
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