NCT01302106撤回2 期
Phase II Study of Clofarabine in Combination With Low Dose Cytarabine for Untreated Patients With Poor Risk Myelodysplastic Syndromes
Fondazione Italiana Sindromi Mielodisplastiche-ETS21 个研究点 分布在 1 个国家开始时间: 2011年2月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 21
- 主要终点
- To assess the remission rate according to the combination regimen
研究概览
简要总结
This is an interventional, multicenter, open label, phase II study designed to evaluate the safety and efficacy of Clofarabine in combination with low dose Cytarabine in untreated patients with poor risk of Myelodisplastic Syndromes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients age 55 to 80 years
- •Written informed consent to participate in the clinical trial
- •Morphologically confirmed diagnosis of MDS according to WHO classification, and IPSS INT-2 or high risk according to IPSS index
- •ECOG performance status 0-2
- •No previous chemotherapy
- •Serum bilirubin ≤1.5 times upper limit of normal (ULN) (unless elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis, but not to liver dysfunction)
- •AST and ALT ≤2.5 times ULN
- •Alkaline phosphatase ≤2.5 times ULN
- •Serum creatinine ≤ 1 mg/dl: if serum creatinine > 1.0 mg/dl, then the estimated glomerular filtration rate (GFR) must be >60 mL/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation where Predicted GFR (ml/min/1.73 m2) = 186 x (Serum Creatinine) -1.154 x age in years -0-023 x 0.742 (if patient is female) x 1.212 (if patient is black)
- •HIV negative
排除标准
- •Have had any other chemotherapy or any investigational therapy as a treatment for MDS. Patients who received chemotherapy for other cancers than MDS/AML can be enrolled, provided that at least 6 months elapsed from accomplishment of the last course of chemo.
- •Have had a prior hematopoietic stem cell transplant for MDS
- •Have an uncontrolled systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
- •Have a psychiatric disorder that would interfere with consent, study participation, or follow-up.
- •Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart
- •Have had any prior treatment with Clofarabine
- •Have had a diagnosis of another malignancy, unless the patient has been disease-free for at least 3 years following the completion of curative intent therapy with the following exceptions: a.)Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease -free duration, are eligible for this study if definitive treatment for the condition has been completed. b.)Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed.
- •Have prior positive test for the Human Immunodeficiency Virus (HIV), HCV, HBV.
研究组 & 干预措施
Arm 1
Experimental
Clofarabine combined with low dose Ara-C
干预措施: Clofarabine plus low dose Ara-C (Drug)
结局指标
主要结局
To assess the remission rate according to the combination regimen
时间窗: 19 months
次要结局
- Time to transformation in AML(19 months)
- To determine the relationship of cytogenetic abnormalities and response to treatment(19 months)
- To determine the safety and tolerability of the combination regimen(19 months)
- Duration of response and survival(19 months)
研究者
研究点 (21)
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