EUCTR2011-001919-31-DK进行中（未招募）1 期
DALIAHA Danish Study of Low-dose Interferon Alpha Versus Hydroxyurea in the Treatment of Ph-negative Chronic Myeloid Neoplasias - A National Randomized Prospective Study With Focus on Efficacy, Toxicity and Quality of Life - DALIAH
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or female > 18 years of age
- •2.Newly diagnosed or previously untreated patients with ET, PV or PMF including prefibrotic
- •myelofibrosis according to the WHO classification
- •3.Active disease defined by one of the following criteria:
- •- need for phlebotomy
- •- leukocytosis > 10 mia/l
- •- thrombocytosis > 400 mia/l
- •- constitutional symptoms (fatigue, weight loss, night sweats or
- •fewer > 38 degrees celsius)
- •- Pruritus
- •- splenomegali causing symptoms
- •- previous thrombosis
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •-Fertile women without a negative pregnancy test
- •-Other malignant disease within last 5 yaers
- •-ECOG performance score >/= 3
- •-Creatinine > 2x ULN
- •-Bilirubin > 1.5x ULN
- •-ALAT > 3x ULN
- •-Previous psyciatric disorder (depression)
- •-active autoimmune disease
- •-Uncontrolled thyroid disease
研究者
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