A multicenter phase II, open label, single arm study to evaluate the efficacy and safety of ruxolitinib in the treatment of anemic myelofibrosis patients - REALISE

ovartis Pharma Services AG0 个研究点目标入组 50 人开始时间: 2016年11月29日最近更新: 2019年4月30日

研究概览

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•- Male or female patients aged = 18 years of age.
•- Patients must be diagnosed with PMF, according to the 2016 revised International Standard Criteria (Arber et al, 2016), PPV MF or PET-MF (Barosi 2008), irrespective of JAK2 mutation status.
•- Patients with palpable splenomegaly that is equal to or greater than 5 cm below the left costal margin.
•- Patients with a hemoglobin less than 10 g/dL
•- Patients with a history of transfusions must have a documented transfusion record in the previous 12 weeks to baseline.
•- Patients with a peripheral blood blast percentage count of < 10%.
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•- Patients with prior treatment with any JAK1 or JAK2 inhibitor.
•- Patients with inadequate bone marrow reserve at baseline visit asdemonstrated by at least one of the following:
•? ANC that is = 1,000/µL.
•? Platelet count that is <50,000/µL without the assistance of growth factors, thrombopoietic factors or platelet transfusions.
•? Hemoglobin count that is = 6.5 g/dL despite transfusions.
•- Patients with severely impaired renal function
•- Patients with inadequate liver function
•- Patients being treated concurrently with a strong (potent) systemic inhibitor or inducer of CYP3A4 at the time of Screening
•- Acute viral hepatitis or active chronic hepatitis B or C infection.
•- History of progressive multifocal leuko-encephalopathy (PML)
•Additional exclusion criteria as per full protocol may apply.

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