EUCTR2019-000373-23-IT进行中（未招募）1 期
A randomized, open-label, phase I/II open platform study evaluating safety and efficacy of novel ruxolitinib combinations in myelofibrosis patients - ADORE
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects have diagnosis of primary myelofibrosis (PMF) according to the 2016 World Health Organization (WHO) criteria, or diagnosis of post-essential thrombocythemia (ET) (PET-MF) or post-polycythemia vera (PV) myelofibrosis (PPV-MF) according to the International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) 2007 criteria
- •Palpable spleen of at least 5 cm from the left costal margin (LCM) to the point of greatest splenic protrusion or enlarged spleen volume of at least 450 cm3 per MRI or CT scan at baseline (a MRI/CT scan up to 8 weeks prior to first dose of study treatment can be accepted).
- •Have been treated with ruxolitinib for at least 24 weeks prior to first dose of study treatment
- •Are stable (no dose adjustments) on the prescribed ruxolitinib dose (between 5 and 25 mg twice a day (BID)) for = 8 weeks prior to first dose of study treatment.
- •Hemoglobin < 10 g/dL
- •Part 1: Platelet counts = 75 000/µL
- •Part 2 and Part 3: Platelet counts = 50 000/µL
- •Additional inclusion criteria as per full protocol may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 97
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 33
排除标准
- •Not able to understand and to comply with study instructions and requirements.
- •Received any investigational agent for the treatment of MF (except ruxolitinib) within 30 days of first dose of study treatment or within 5 half-lives of the study treatment, whichever is greater
- •Peripheral blood blasts count of > 10%.
- •Received a monoclonal antibody (Ab) or immunoglobulin-based agent within 1 year of screening, or has documented severe hypersensitivity reactions/immunogenicity (IG) to a prior biologic
- •Splenic irradiation within 6 months prior to the first dose of study drug
- •Received blood platelet transfusion within 28 days prior to first dose of study treatment.
- •Subjects with known TP53 mutation or deletion of TP53
- •Additional exclusion criteria as per full protocol may apply.
研究者
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