EUCTR2019-000373-23-DE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
- 240
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 12 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 = 4 weeks prior to first dose of study treatment.
- •Hemoglobin < 11 g/dL (= 6.8 mmol/L)
- •Part 1: Platelet counts = 75 000/µL
- •Part 2 and Part 3: Platelet counts = 50 000/µL
- •Key inclusion criteria for the extension treatment phase are listed below,
- •please refer to the protocol for the full list of inclusion criteria:
- •Signed informed consent form prior to participation
- •On going in the core treatment phase
- •Demonstrated clinical benefit in the core treatment phase per
- •investigator's assessment.
- •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 177
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 63
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%.
- •Had history of documented severe hypersensitivity
- •reactions/immunogenicity to a prior biologic product in any treatment
- •arm OR received a monoclonal antibody (Ab) or immunoglobulin-based
- •- for treatment arms with NIS793, crizanlizumab or sabatolimab within 1
- •year of screening
- •- for treatment arms with rineterkib or siremadlin arms within <=4
- •weeks of screening or <=5 half-lives whichever is shorter for rineterkib
- •or siremadlin arms
- •- for Part 2 and Part 3, the longest window will apply based on the
- •compounds opened for randomization
- •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. NOTE: PRBC transfusions are permitted
- •Subjects with known TP53 mutation or deletion of TP53
- •Use of systemic steroid therapy and other immunosuppressive drugs
- •within 14 days prior to first dose of study treatment (> 10 mg/day
- •prednisone or equivalent). Topical, inhaled, nasal, and ophthalmic
- •steroids are allowed. Replacement therapy, steroids given in the context
- •XML File Identifier: vqTUMZ8xU4hhiohIfZSDKEGkXnI=
- •of a transfusion are allowed and not considered a form of systemic
- •Occurrence of any clinically significant bleeding events within 6
- •months prior to first dose of study treatment.
- •For patients treated with rineterkib in Part 1 and for all patients in
- •Part 2 and Part 3 (if an rineterkib arm is included in the randomization
- •for Part 2 or Part 3): Pre-existing retinal vein occlusion (RVO) or current
- •risk factors (apart from the underlying MF) for RVO.
- •Key exclusion criteria for the extension treatment phase are listed
- •below, please refer to the protocol for the full list of exclusion criteria:
- •Patient meeting the list of discontinuation criteria
- •Evidence of treatment failure
- •Enrollment in another interventional study
- •Non-compliance of the subject or consent withdrawal
- •Unresolved toxicities for which treatment has been interrupted in the
- •core treatment phase
- •Subject has local access to alternative myelofibrosis treatment as
- •assessed suitable in the opinion of the investigator.
研究者
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