EUCTR2008-008262-12-FR进行中（未招募）1 期
A phase II study evaluating the efficacy and safety of Lenalidomide (Revlimid®) with or without Epoetin beta (NeoRecormon®) in transfusion-dependent ESA-resistant patients with IPSS low- and intermediate-1 risk myelodysplastic syndromes without chromosome 5 abnormality - GFM-Len-Epo-08
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 126
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
- •MDS defined as
- •Low or int-1 IPSS score
- •Documented absence of chromosome 5 abnormality (del(5q) or -5 karyotype)
- •De novo MDS, excluding therapy-related MDS
- •Transfusion dependance (requirement of at least 4 units of RBC transfusions every 8 weeks )
- •Resistance or loss of response to a previous treatment with Epoetin alpha/beta (at least 60,000 Units/w) or Darbepoetin (at least 250 µg/w), for at least 12 weeks
- •Ineligibility for allogeneic stem cell transplantation or intensive chemotherapy during the next 12 months
- •ECOG performance status = 2
- •Age = 18 years
- •Life expectancy = 3 months
- •Adequate liver function (transaminases serum levels = 3N)
- •Adequate renal function (ca lculate creatinine clearance > 50 ml/min)
- •Female subjects of chilbearing potential* must :
- •-Understand the study drug is expected to have a teratogenic risk.
- •-Understand that even if she has amenorrhea, she must follow all the advice on effective contraception.
- •-She understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy
- •Male patients taking lenalidomide must :
- •-Agree the use of a condom if engaged in sexual activity with a woman of childbearing potential, during the entire period of treatment, even if dysruption of treatment and during one week after end of treatment.
- •-Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
- •All subjects must :
- •-Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
- •-Agree not to share study medication with another person and to return all unused study drug to the investigator.
- •Signed informed consent prior to start of any study-specific procedures
- •Ability to participate to a clinical trial and adhere to study procedures
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Active serious infection not controlled by oral or intravenous antibiotics
- •Platelets less than 50 G/L
- •Prior history of deep vein thrombosis or pulmonary embolism
- •Previous treatment by Thalidomide
- •Treatment with any investigational antileukemic agent or chemotherapy at least 6 weeks prior to study entry and lack of full recovery from side effects due to prior therapy independent of when that therapy were given
- •Rapidely progressive disease with copromised organ function judged to be life-threatening by the Investigator
- •Pregnant or lactating female
- •Known human immunodeficiency virus (HIV) infection
- •Known active hepatitis B and/or C virus infection
- •Hypersensitivity or intolerance to Lenalidomide or any of the excipients
- •Hypersensitivity to Epoetin beta or any of the excipients
- •Uncontrolled arterial hypertension
研究者
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