JPRN-jRCT2041210029进行中（未招募）2 期
[M16-109] A Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Participants With Myelofibrosis (REFINE)
Okubo Sumiko0 个研究点目标入组 15 人开始时间: 2021年6月9日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Participants with documented diagnosis of intermediate-2 or high-risk primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis.
- •- Participant must be ineligible or unwilling to undergo stem cell transplantation at time of study entry.
- •- Eastern Cooperative Oncology Group (ECOG) of 0,1, or 2.
- •- Participant must have either received prior treatment with ruxolitinib OR another Janus Kinase 2 (JAK-2) inhibitor therapy OR must not have received any prior treatment with JAK-2 inhibitor or BET inhibitor.
- •- Participant has splenomegaly as defined in the protocol.
- •- Participant must meet the laboratory parameters (adequate bone marrow, renal and hepatic function) as defined in the protocol.
排除标准
- •- Splenic irradiation within 6 months prior to screening, or prior splenectomy.
- •- Leukemic transformation (> 10% blasts in peripheral blood or bone marrow biopsy).
- •- Participant is currently on medications that interfere with coagulation (including warfarin) or platelet function with the exception of low dose aspirin (up to 100 mg) and Low-molecular-weight heparin.
- •- Prior therapy with a BH3 mimetic compound.
- •- Participant has received strong or moderate CYP3A inhibitors (e.g., ketoconazole, clarithromycin) or moderate CYP3A inhibitors (e.g., fluconazole) within 14 days prior to the administration of the first dose of study drug.
研究者
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