EUCTR2013-003295-12-DK进行中（未招募）1 期
Combination Therapy Interferon Alpha + JAK1-2 Inhibitor in The Ph-Negative Chronic Myeloid Neoplasms
Roskilde University Hospital0 个研究点目标入组 50 人开始时间: 2013年10月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- •3.1 Inclusion Criteria
- •1. Male or female patients> 18 years.
- •2. Patients with early prefibrotic myelofibrosis /post-ET myelofibrosis , PV, Post-PV myelofibrosis or hyperproliferative PMF according to WHO classification.
- •3. Active disease defined by one or more of the following criteria, at some time before study enrollment and accordingly not necessarily at the time or weeks before enrollment :
- •a) Need for venesection (hematocrit> 0.42 in females and > 0.45 in males)
- •b) White blood cell counts > 10 MIA/L in the absence of infection / inflammation.
- •c) Platelet count> 400 MIA/L in the absence infection / inflammation.
- •d) Hypermetabolic symptoms such as weight loss (> 10% within 6 months), night sweats and subfebrilia (temperature> 38 º C for more than 2 weeks without signs of infection)
- •e) Pruritus
- •f) Symptomatic splenomegaly
- •g) Presence of 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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •3.2 Exclusion Criteria
- •1. Childbearing potential patients without a negative pregnancy test prior to initiation of study drug and / or non-acceptance of the use of effective contraceptive methods *
- •2. Other active malignancy within the past 5 years (except basal cell carcinoma of the skin).
- •3. ECOG function scores> / = 3
- •4. Serum creatinine more than 2 x ULN
- •5. Total serum bilirubin greater than 1.5 x ULN
- •6. Plasma ALT more than 3 x ULN
- •7. Former psychiatric disorder (depression diagnosed by a psychiatrist)
- •8. Uncontrolled metabolic disease.
- •9. Severe heart disease (heart failure NYHA class 3-4).
- •10. Severe myelosuppression. (leucocyte count<1.5 Mill/L, Platelet count<100)
- •11. Chronic hepatitis with decompensated cirrhosis.
- •12. Chronic hepatitis in patients who have been or recently (within 6 months) has been treated with immunosuppressive drugs with the exception of corticosteroid treatment.
- •13. Epilepsy and / or other serious CNS disorders.
- •14. Known hypersensitivity to recombinant interferon (Pegasys or PegIntron) and JAKAVI, or to one or more of these preparations .
- •* Spiral, birth control pills, implants, transdermal patch, vaginal ring or transdermal injection.
- •Sterile / infertile subjects are exempt from the use of contraception. In order to be considered sterile or infertile, one must generally be surgically sterilized (vasectomy, bilateral tubectomy, hysterectomy or ovariectomy) or be postmenopausal, defined as absent menstruation for at least 12 months before study enrollment.
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