EUCTR2009-010738-23-DE进行中（未招募）1 期
Multi-Center Phase II Study with Pomalidomide in Patients with Myeloproliferative Neoplasms in Fibrotic Stage - MPNSG 01-09
niversitätsklinikum Ulm0 个研究点目标入组 95 人开始时间: 2009年9月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 95
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.Age =50 years at the time of voluntarily signing an IRB/IEC-approved informed consent
- •2.Diagnosis of Myeloproliferative Neoplasms (MPN) either de novo myelofibrosis according to WHO criteria (PMF), secondary myelofibrosis (post-PV MF and post-ET MF according to the IWG-MRT consensus terminology) or unclassifiable MPN with biopsy proven myelofibrosis
- •3.Anemia with hemoglobin level of <10 g/dl or transfusion-dependent anemia and/or
- •thrombocytopenia <50 /nl or transfusion-dependent thrombocytopenia
- •and/or neutropenia <1.0 /nl
- •4.Splenomegaly (>11 cm diameter) and/or leukoerythroblastosis
- •5.Adequate organ function, i.e. ALT and/or AST <3 x upper limit of normal (ULN), total bilirubin <3 x ULN, and serum creatinine <2 mg/dl
- •6.Subject must be willing to receive transfusion of blood products
- •7.ECOG performance status <3
- •8.Female subjects with non-childbearing potential°,
- •- Must have one medically supervised negative serum or urine pregnancy tests prior to starting study drug.
- •9.Male subjects
- •- must agree to use condoms throughout study drug therapy, during any dose interruption and for four weeks after cessation of study therapy if their partner is of childbearing potential and has no contraception - even if they have undergone a successful vasectomy.
- •- must agree not to donate semen during study drug therapy and for 90 days following discontinuation of pomalidomide.
- •10.All Subjects (males and females)
- •- Will be counseled about potential teratogenic risks of the study medication.
- •- must agree to abstain from donating blood while taking study drug therapy and for at least 28 days following discontinuation of pomalidomide.
- •- must agree not to share study medication with another person and to return all unused study drug to the investigator
- •- Only enough pomalidomide for one cycle of therapy may be dispensed with each cycle of therapy.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 71
排除标准
- •1.Females of childbearing potentials, pregnant or breast feeding females
- •2.BCR/ABL-positivity
- •3.Diagnosis of ET (according to WHO 2008 criteria)
- •4.Diagnosis of PV (according to WHO 2008 criteria)
- •5.>20% blasts in peripheral blood or bone marrow
- •6.Known positive status for HIV, HBV or HCV
- •7.Prior treatment with IMiDs (thalidomide, lenalidomide) or with Interferon-alpha within a 3 month time period before screening
- •8.History of thrombosis or pulmonary embolism
- •9.Peripheral neuropathy >grade 1 CTC
- •10.No consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician about study participation.
- •11.Presence of any medical/psychiatric condition or laboratory abnormalities which may limit full compliance with the study, increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study
- •12.Drug or alcohol abuse within the last 6 months
- •13.Patients with a currently active” second malignancy other than non-melanoma skin cancers. Patients are not considered to have a currently active” malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year.
研究者
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