A phase 2 study of the efficacy and safety of Deferasirox administered at early iron loading in patients with transfusion-dependent myelodysplastic syndromes

niversity of Birmingham (UK)0 个研究点目标入组 13 人开始时间: 2013年7月5日最近更新: 2020年3月3日

研究概览

暂无简介。

•1. At least 18 years old
•2. Written informed consent
•3. MDS with:
•3.1. 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.
•3.2. Serum ferritin > 300 ug/l but < 1000 ug/l in absence of ongoing inflammation (CRP < 3 x ULN)
•3.3. Serum creatinine < 1.2 x ULN and/or creatinine clearance > 40 ml/min
•3.4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5 ULN
•3.5. International Prognostic Scoring System (IPSS) Low/INT-1 previously untreated or having failed a therapeutic trail of erythropoetic stimulating agents (ESA) or other active MDS drug therapy, or alternatively lost their response to such therapy
•3.6. IPSS INT-2 with <10% blasts and lacking a complex karyotype or monosomy 7 (and with stable blood counts from diagnosis to study entry)
•Target gender: male & female

•1. 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
•2. Life expectancy of less than 1 year
•3. Known HIV positive
•4. Active infection
•5. Use of prior investigational agents within 6 weeks
•6. Pregnancy or lactation
•7. Other severe concurrent medical illness that limit the patient?s prognosis to <1 year, or psychiatric disorders
•8. 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
•9. Ongoing inflammation as measured by C-reactive protein (CRP) > 3 x ULN
•10. Serum creatinine > 1.2 x ULN and/or creatinine clearance <40 mls/min
•11. ALT or AST >2.5 ULN
•12. History of drug/alcohol abuse or non-compliance

发起方

niversity of Birmingham (UK)