An open-label, multi-center, Expanded Treatment Protocol (ETP) of ruxolitinib in patients with Polycythemia Vera who are Hydroxyurea resistant or intolerant and for whom no treatment alternatives are available

ovartis Pharma Services AG0 个研究点目标入组 500 人开始时间: 2016年5月3日最近更新: 2018年6月5日

适应症

试验速览

暂无简介。

•1. Male or female aged 18 or over
•2. Confirmed diagnosis of PV according to the revised World Health Organization (WHO) criteria with resistance or intolerance to hydroxyurea
•3. Peripheral blood blast count of 0% at screening
•4. ECOG performance status of 0, 1, or 2 at Baseline
•5. Must have recovered or stabilized sufficiently from adverse drug reactions associated with any prior treatments before beginning treatment with ruxolitinib
•6. Does not have access to a comparable or satisfactory alternative treatment (i.e., comparable or satisfactory treatment is not available or does not exist)
•7. Is not eligible for participation in any of the ruxolitinib ongoing clinical trials or has recently completed a clinical trial that has been terminated and, after considering other options (e.g., trial extensions, amendments, etc.), the clinical team has determined that treatment is necessary and there are no other feasible alternatives for the patient)
•8. Is not being transferred from an ongoing clinical trial for which he/she is still eligible
•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 200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 300

•1. Inadequate liver or renal function
•2. Platelet counts < 50 ×109/L or an Absolute Neutrophil Count (ANC) < 1 × 109/L at screening
•3. Presence of active bacterial, fungal, parasitic or viral infection which require therapy
•4. History of progressive multifocal leukoencephalopathy (PML)
•5. Significant concurrent, uncontrolled medical condition that, in the Investigator’s opinion would jeopardize the safety of the patient or compliance with the protocol
•Other exclusion criteria as per protocol section 5.3 may apply.

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