NCT02087059已完成3 期
A Multicenter, Open-label Clinical Study of the JAK Inhibitor Ruxolitinib (INC424) in Patients With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
This is an open-label, multicenter clinical study in order to collect and examine data concerning the safety and efficacy of ruxolitinib in patients with Primary Myelofibrosis (MF), Post-Polycythemia Vera (PV) MF, Post-Essential Thrombocythemia (ET) MF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •Diagnosis of PMF, PPV-MF, or PET-MF, regardless of JAK2 mutational status. The diagnostic of PMF will be according to the World Health Organization (WHO) criteria (Thiele et al., 2008) and PPV-MF and PET-MF according to the International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) criteria (Barosi et al., 2008).
- •At least one risk factors provided in the definition of IWG-MRT (Cervantes et al., 2009; classified as intermediate risk-1, intermediate risk-2, or high risk)
- •Patients with intermediate risk-1 (patients who have only one of the IMG-MRT risk factors indicated above ) must have palpable splenomegaly with a length of ≥5 cm from the costal margin to the point of the greatest spleen protrusion.
- •Proportion of blasts in peripheral blood <10%
- •ECOG performance status of 0 to 2
- •The following values for bone marrow function prior to treatment:
- •Absolute neutrophil count ≥1,000/μL, and
- •Platelet count ≥50,000/μL without administration of a growth factor, thrombopoietin, or platelet transfusion
- •Stem cell transplantation is not a treatment option at present because it is not indicated or because there are no suitable donors.
- •All drugs used to treat MF were discontinued at least 28 days before treatment initiation.
- •Informed consent form should be signed before any screening procedures is performed
排除标准
- •Hepatic or renal impairment as indicated by the following:
- •Direct bilirubin ≥2-fold than the upper limit of normal (ULN)
- •Alanine aminotransferase (ALT) >2.5-fold ULN
- •Creatinine >2.0 mg/dL
- •Clinically significant infection by bacteria, fungus, mycobacteria, parasite, or virus (screening and enrollment postponed until completion of antibiotic treatment in patients with an acute bacterial infection that requires antibiotic use)
- •Active hepatitis A, B, or C or HIV infection defined by a positive IgM-HA Ab test [hepatitis A virus antibody (immunoglobulin M [IgM])], HBs Ag test (hepatitis B surface antigen), HCV Ab test (hepatitis C virus antibody), or HIV Ab (human immunodeficiency virus antibody) at screening.
- •History of malignancy within the previous 3 years, except for early-stage squamous cell carcinoma and basal cell carcinoma.
- •History of serious congenital or acquired hemorrhagic disease
- •Previous platelet count <25,000/μL or absolute neutrophil count <500/μL, except for patients currently undergoing treatment for a myeloproliferative neoplasm or cytotoxic therapy for any other reason.
- •Splenic irradiation within 12 months before screening
- •Administration of hematopoietic growth factor receptor agonists (erythropoietin, granulocyte colony stimulating factor, romiplostim, eltrombopag) within 14 days before screening or 28 days before treatment initiation.
- •Currently receiving another investigational drug, or received another investigational drug within 30 days before the start of treatment.
- •History of myocardial infarction or acute coronary syndrome within 6 months before screening
- •Poorly controlled or unstable angina at present
- •Rapid or paroxysmal atrial fibrillation at present
- •Active alcohol or drug addiction that could hinder the patient's ability to comply with the study's requirements
- •Pregnant or currently breastfeeding woman
- •Women of childbearing potential or men with reproductive ability who are unwilling to take appropriate contraception measures
- •Patient with any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol
- •History of hypersensitivity to the study drug or a drug with a similar chemical structure
研究组 & 干预措施
Ruxolitinib
Experimental
Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
干预措施: Ruxolitinib (Drug)
结局指标
主要结局
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
时间窗: 24 weeks
次要结局
- Charge in Spleen Size From Baseline at Specified Week(Baseline, 24 weeks)
- Charge in Spleen Size From Baseline up to the Specified Week(Baseline, 24 weeks)
- Summary of Total Symptom Score as Measured by Seven-day Modified Myelofibrosis Symptom Assessment Form (MFSAF) v2.0 by Time(24 weeks)
- Summary of Summary of EORTC QLQ-C30 Responses by Time(24 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
1 期
Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Non-Small Cell Lung CancerLocally Advanced or Metastatic Non-Small Cell Lung CancerNCT04448379Shanghai JMT-Bio Inc.48
尚未招募
4 期
Clinical Study of Huaier Granules in Patients With Advanced Breast Cancer Without Visceral MetastasisBreast Cancer Stage IVNCT05860907Fudan University384
招募中
2 期
Clinical Study of Reduced-dose Pomalidomide and Cyclophosphamide Combined With Dexamethasone in the Treatment of Patients With Debilitating RRMMMultiple Myeloma in RelapseNCT06255847Shanxi Bethune Hospital43
已完成
不适用
PAAG-OA Treatment for Knee OsteoarthritisOsteoarthritis, KneeNCT04179552Contura49
Unknown
1 期
Efficacy and Safety of JMT101 in Patients With Advanced Solid TumorAdvanced Solid TumorNCT04689100Shanghai JMT-Bio Inc.259