NCT00803530终止2 期
Phase II Multicenter Study of Association of Arsenic Trioxide (ATO) and Ascorbic Acid in Myelodysplastic Syndromes
Fondazione Italiana Sindromi Mielodisplastiche-ETS13 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2005年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 55
- 试验地点
- 13
- 主要终点
- TO evaluate the erythroid response rate (major), according to the International Working Group (IWG) criteria (42) after four months of treatment with the association of ATO and ascorbic acid.
研究概览
简要总结
This is a prospective, multicenter phase II trial designed to evaluate the safety and activity of the combination of association of arsenic trioxide (ATO) and ascorbic acid in patients with myelodysplastic syndromes
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients affected by myelodysplastic syndromes, entering in one of the following groups:
- •Myelodysplastic syndromes independent of WHO diagnostic classification (43) and IPSS prognostic score (2), when present at least one of the following abnormalities:
- •3q26 chromosome rearrangement.
- •High EVI-1 transcript levels.
- •Myelodysplastic syndromes without excess of blasts (non-RAEB patients) at low or intermediate-1 score risk according to the IPSS (2), as a second line treatment option, after a failure to the first line treatment with erythropoietin +/- G-CSF, immunosuppressive therapy, or other initial treatment modality.
- •Non RAEB patients at intermediate-2 or high risk score or RAEB patients at any prognostic score, who are non candidate to treatment with conventional chemotherapy regimens.
- •Presence of one ore more cytopenias characterised by one ore more of the following elements:
- •Transfusions dependence.
- •Hb< 11 gr/dl
- •Platelet count < 50x109/L
- •Absolute neutrophil count < .5x109/L.
- •ECOG Performance status ≤
- •Aged from 18 to
- •Life expectancy > 4 months.
- •Creatinine level < 1.5 mg/dl.
- •Liver function tests, including ASL-ALT-alkaline phosphatase lower than 3xULN
- •No previous treatment with chemotherapy, growth factors, cytokines or other experimental treatment within 4 weeks of starting treatment.
- •No history of clinically significant cardiac disease, including congestive heart failure.
- •Cytogenetic evaluation available.
- •Sending of both peripheral blood and bone marrow sample to the central laboratory for EVI-1 rearrangement evaluation.
- •Written Informed consent.
排除标准
- •Patients affected by myelodysplastic syndromes entering in categories other than those foreseen by inclusion criteria point
- •Absence of cytopenia defined as the contemporarily presence of all the following conditions: a) no transfusion need; b) Hb > 11 gr/dl; c) platelet count > 50x109/L; d) absolute neutrophil count > .5x109/L.
- •All patients that might be candidate to allogenic stem cell transplantation.
- •Patients that might be candidate to a first line immunosuppressive therapy.
- •ECOG Performance status >
- •Age lower than 18 or higher then
- •Life expectancy < 4 months.
- •Creatinine level > 1.5 mg/dl.
- •Liver function tests, including ASL-ALT-alkaline phosphatase higher than 3xULN
- •Treatment with chemotherapy, growth factors, cytokines or other experimental treatment within 4 weeks of starting treatment.
- •Clinically significant cardiac disease, including congestive heart failure, rhythm abnormalities, QT time > 460m/s, or need of anti-arrhythmic drugs.
- •Concurrent co-morbid medical condition which might exclude administration of therapy, as judged by individual investigator.
- •Absence of cytogenetic evaluation.
- •Participation at same time in another study in which investigational drugs are used.
- •Absence of written Informed consent.
研究组 & 干预措施
1
Experimental
Loading phase (week 1): ATO 0.3 mg/Kg/die for 5 consecutive days.
- Subsequent phase (from week 2 to week 16): ATO 0.25 mg/kg twice a week (day 2 and 5 of every week).
- Ascorbic acid 1000 mg IV within 30 minutes after each arsenic trioxide infusion for 16 consecutive weeks.
干预措施: ATO + Ascorbic acid (Drug)
结局指标
主要结局
TO evaluate the erythroid response rate (major), according to the International Working Group (IWG) criteria (42) after four months of treatment with the association of ATO and ascorbic acid.
时间窗: 16 mounths
次要结局
- To evaluate platelets and granulocyte response according to the International Working Group (IWG) criteria (42) after four months of treatment with the association of ATO and ascorbic acid(16 mounths)
研究者
研究点 (13)
Loading locations...
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