ACTRN12614000740695招募中3 期
A Randomized Controlled Phase 3 Study of Oral Pacritinib Versus Best Available Therapy in Patients With Thrombocytopenia and Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis
Cell Therapeutics Inc.0 个研究点目标入组 300 人开始时间: 2014年7月11日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Intermediate -1 or -2 or high-risk Myelofibrosis (per Passamonti et al 2010)
- •Thrombocytopenia (platelet count greater than 100,000/microlitre) at any time after signing informed consent
- •Palpable splenomegaly greater than 5 cm on physical examination
- •Total Symptom Score less than 13 on the MPN-SAF TSS 2.0, not including the inactivity question
- •Patients who are platelet or red blood cell transfusion-dependent are eligible
- •Adequate white blood cell counts (with low blast counts), liver function, and renal function
- •At least 6 months from prior splenic irradiation
- •At least 1-4 weeks since prior myelofibrosis therapy, including any erythropoietic or thrombopoietic agent
- •Not pregnant, not lactating, and agree to use effective birth control
- •Able and willing to undergo frequent MRI or CT assessments and complete symptom assessments using a patient-reported outcome instrument
排除标准
- •Prior treatment with more than 2 JAK2 inhibitors or with pacritinib
- •More than 6 months of cumulative prior JAK2 inhibitor treatment
- •History of (or plans to undergo) spleen removal surgery or allogeneic stem cell transplant
- •Ongoing gastrointestinal medical condition such as Crohn's disease, Inflammatory bowel disease, chronic diarrhea, or constipation
- •Active bleeding that requires hospitalization during the screening period
- •Cardiovascular disease, including recent history or currently clinically symptomatic and uncontrolled: congestive heart failure, arrhythmia, angina, QTc prolongation or other QTc risk factors, myocardial infarction
- •Other malignancy within last 3 years other than certain limited skin, cervical, prostate, breast, or bladder cancers
- •Other ongoing, uncontrolled illnesses (including HIV infection and active hepatitis A, B, or C), psychiatric disorder, or social situation that would prevent good care on this study
- •Life expectancy < 6 months
研究者
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3 期
A Randomized Controlled Phase 3 Study of Oral Pacritinib versus Best Available Therapy in Patients with Thrombocytopenia and Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia MyelofibrosisNL-OMON40900CTI BioPharma Corp.10