EUCTR2010-018467-42-DE进行中（未招募）1 期
Comparison between 5 – azacytidine treatment and 5 – azacytidine followed by allogeneic stem cell transplantation in elderly patients with advanced MDS according to donor availability - VidazaAlloStudy
niversity Medical Center Hamburg-Eppendorf0 个研究点目标入组 110 人开始时间: 2010年10月25日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
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
入选标准
- •Patients with proven de novo or therapy-related MDS / CMML (WBC <13 GPT/l) according to FAB and risk profile according to IPSS: intermediate II-risk or high-risk or intermediate I with high-risk cytogenetic (according to IPSS, taking into account that IPSS, however, was not validated for t-MDS), patients with secondary AML (according to WHO) and blasts = 30 % (= RAEB-t according to FAB)
- •Previously untreated or maximal 1 cycle of 5-azacytidine (Vidaza®)
- •Age 55 – 70 years
- •Understand and voluntarily sign an informed consent form
- •ECOG performance status of = 2 at study entry
- •Adequate renal and liver function: creatinine and bilirubine < 3 x the upper limit of normal
- •Sufficient cardiac function (ejection fraction > 30 %)
- •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 76
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 34
排除标准
- •Blasts > 30 % in bone marrow at time of diagnosis
- •Central nervous involvement
- •Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
- •Total bilirubin, SGPT or SGOT = 3 times upper the normal level
- •Left ventricular ejection fraction < 30 %
- •Creatinine clearance < 30 ml/min
- •DLCO < 35 % and/or receiving supplementary continuous oxygen
- •Pregnant or breastfeeding female subject
- •Patients with a life-expectancy of less than six months because of another debilitating disease
- •Serious psychiatric or psychological disorders
- •Uncontrolled invasive fungal infection at time of registration
- •Known positive for HIV or acute infectious hepatitis, type A, B or C
- •Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment until the end of the study
研究者
相似试验
进行中（未招募）
不适用
?Clinical and biological effects of 5-Azacitidine five days/monthly schedule in symptomatic low-risk myelodysplastic syndromes (MDSs)? - MDS0706EUCTR2007-003943-55-ITAZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
进行中（未招募）
不适用
A Randomised Phase II trial of 5-Azacitidine versus 5-Azacitidine in combination with Vorinostat in patients with relapsed Acute Myeloid Leukaemia ineligible for intensive chemotherapyEUCTR2011-005207-32-GBThe University of Birmingham
已完成
2 期
Efficacy and safety of a 5-day regimen of azacitidine in patients with low-risk myelodysplastic syndromeJPRN-UMIN000005662Department of Hematology, Kinki University School of Medicine50
已完成
2 期
Phase II study of combination therapy with 5-AZAcytidine, Valproic acid, and All-Trans Retinoic Acid in patients with myelodysplastic syndromes and other myeloid malignancies who cannot receive intensive chemotherapyMyelodysplastic syndromes (MDS)NeoplasmsCancerISRCTN92868457Heinrich-Heine-University (Germany)24
进行中（未招募）
1 期
Pilot study of 5 Azacitidine in the treatment of MDS/AML with high risk (chromosome 7 and/or complex cytogenetic abnormality) - Azacitidine for MDS with high risk cytogeneticsmyelodysplastic syndromes/relapsed Acute myeloid leukaemiaEUCTR2005-003732-22-GBKings College London43