EUCTR2011-004559-38-GB进行中（未招募）1 期
A phase 2 study of the efficacy and safety of Deferasirox administered at early iron loading in patients with transfusion-dependent Myelodysplastic Syndromes. - Deferasirox for early iron loading in transfusion-dependant MDS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 13
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
- •At least 18 years old.
- •Written informed consent.
- •MDS with:
- •o Baseline haemoglobin concentration < 11 g/dl and clinically requiring red cell transfusion with a frequency of at least 2 units every 6 weeks for the receding 12 week period.
- •o Serum ferritin >300µg/l but <1000 µg/l in absence of ongoing inflammation (CRP < 3 x ULN)
- •o Serum creatinine <1.2 x ULN and/or creatinine clearance > 40 mls/min
- •o ALT or AST < 2.5 ULN
- •o IPSS Low/INT-1 previously untreated or having failed a therapeutic trial of erythropoetic stimulating agents (ESA) or other active MDS drug therapy, or alternatively lost their response to such therapy
- •o IPSS INT-2 with < 10% blasts and lacking a complex karyotype or monosomy 7 (and with stable blood counts from diagnosis to study entry).
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 29
排除标准
- •Active treatment for MDS, including erythropoetic stimulating agents (ESA), 5-azacitidine, antilymphocyte globulin and low dose chemotherapy such as cytarabine during the trial and within the last 8 weeks
- •Life expectancy of less than 1 year
- •Known HIV positive
- •Active infection
- •Use of prior investigational agents within 6 weeks
- •Pregnancy or lactation
- •Other severe, concurrent medical illness that may affect the patients participation in the study, or psychiatric disorders
- •Concurrent active or previous malignancy, within the last 3 years, – except controlled, localised prostate cancer on hormone therapy or basal cell carcinoma or cervical carcinoma in situ or completely resected colonic polyps carcinoma in situ
- •Ongoing inflammation as measured by CRP > 3 x ULN
- •Serum creatinine >1.2 x ULN and/or creatinine clearance < 40 mls/min
- •ALT or AST >2.5 ULN
- •History of drug/alcohol abuse or non-compliance
研究者
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