ISRCTN88102629进行中（未招募）2 期
A phase II study to evaluate the tolerability, safety and activity of fedratinib combined with ropeginterferon alfa-2b in patients with myelofibrosis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age 18 or over at trial entry
- •2. Confirmed diagnosis of JAK2 V617F positive primary or secondary MF, according to WHO 2016 diagnostic criteria
- •3. Require treatment, as clinically determined by local investigator
- •4. Intermediate-2 or high risk according to DIPSS, or intermediate-1 according to DIPSS with palpable splenomegaly >5cm
- •5. Peripheral blood or bone marrow blasts <10%
- •6. Adequate blood counts: platelets =75 x10-9/L, neutrophils =1.0 x10-9/L
- •7. Adequate organ function
排除标准
- •1. Previous treatment with a JAK2 inhibitor or interferon alpha
- •2. Chemotherapy or biologic therapy within 2 weeks of commencing the trial treatment, or ongoing toxicity relating to prior therapy
- •3. Blood thiamine concentration below lower limit of normal
- •4. Active malignancy treated in the last 2 years
- •5. Pre-existing and uncontrolled thyroid disease, diabetes or autoimmune disease
- •6. History of severe psychiatric disorder, including severe depression, suicidal ideation and suicide attempt
- •7. Current severe or uncontrolled cardiovascular disease
- •8. Previous organ transplantation receiving ongoing immunosuppression
- •9. Evidence of active HIV, HBV or HCV infection
- •10. Pregnant and breast feeding patients and those unwilling to use effective contraception
研究者
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