EUCTR2011-004608-39-IT进行中（未招募）不适用
Eltrombopag in patients with delayed post transplant thrombocytopenia
G.I.M.EM.A. Gruppo Italiano Malattie EMatologiche dell'Adulto0 个研究点开始时间: 2013年3月11日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Age = 18 years;
- •Patients develop delayed thrombocytopenia, i.e. Platelet count ? 50 x 109/l 3 months after SCT;
- •Patients underwent allogeneic SCT with match related or unrelated donor;
- •Patients develop cGVHD-related delayed thrombocytopenia. The definition of cGVHD-related delayed thrombocytopenia is: platelet count ? 50 x 109/l from month 3 from SCT and presence of any clinical, radiological and/or laboratory finding indicative of cGVHD (all grades);
- •Patients underwent SCT because of lymphoma (Hodgkin or non-Hodgkin, indolent or aggressive), or multiple myeloma;
- •Sexually active males who accept to use a condom during intercourse while taking the drug and for 6 months after stopping treatment as they should not father a child in this period. A condom is required to be used also by vasectomised men (as well as during intercourse with a male partner) in order to prevent delivery of the drug via seminal fluid.
- •Female subjects of non-childbearing potential may be enrolled in the study; For this study population, non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause
- •Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to start of eltrombopag, has a negative pregnancy test prior to start of eltrombopag, and has agreed to continue adequate contraception during the entire treatment period and for 6 months after completion of the treatment.
- •Written informed consent obtained from the subject.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Patients underwent SCT with aplo-identical donor or cord blood;
- •Patients underwent SCT for diseases different from lymphoma or multiple myeloma;
- •Patients have life threatening bleeding complications;
- •Patients have an expected survival < 1 month;
- •Patients have delayed thrombocytopenia related to medical conditions other then cGVHD;
- •Patients have progressive non stabilized cGVHD necessitating intensification of immune suppressive treatment in the last 2 weeks;
- •Patients need to introduce or increase the dosage of steroids, any other immune suppressive or cytotoxic agent at the time of enrolment into the study or start of eltrombopag; patients already in treatment with a fixed, stabilized dosage of steroids or other immune suppressive agents because of cGVHD may be included into the study;
- •Patients received concomitant erythropoietin treatment;
- •Patients have active deep venous thrombosis (DVT);
- •Patients have venous occlusive disease (VOD);
- •Patients have grade 3-4 hyper bilirubinemia; elevation of hepatic enzymes because of cGVHD should not be considered criteria of exclusion. Patients with baseline elevation of hepatic enzymes will be monitored carefully in order to point out possible addictive eltrombopag-related hepatotoxicity;
- •Patients have hepatic cirrhosis;
- •Patients have transplant related-microangiopathy;
- •Patients have active infections (CMV reactivation included);
- •Patients have hypersensitive to study drug;
- •Patients are unable to stop medications that are known to cause a drug-drug interaction with eltrombopag.
研究者
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