NCT01459159终止2 期
Phase 2b Study of Oral Ezatiostat Hydrochloride (Telintra®) in Patients With Low to Intermediate-1 Risk, Non-Deletion 5q Myelodysplastic Syndrome
Telik13 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2011年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 162
- 试验地点
- 13
- 主要终点
- Hematologic Improvement-Erythroid (HI-E) rate
研究概览
简要总结
This is a multicenter, single arm open label Phase 2b Study of oral ezatiostat (Telintra®) in Patients who are RBC tranfusion dependent, Low to INT-1 IPSS risk, non-del (5q) Myelodysplastic Syndrome (MDS).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary or de Novo MDS
- •Low to Intermediate-1 IPSS risk of MDS
- •ECOG performance score of 0 or 1
- •Documentation of significant anemia with or without additional cytopenia
- •Adequate kidney and liver function
- •Patients must have discontinued hematopoietic growth factors at least 3 weeks prior to study entry
排除标准
- •Deletion of the 5q chromosome [del(5q) MDS]
- •Prior allogenic bone marrow transplant for MDS
- •Known sensitivity to ezatiostat (injection or oral tablets)
- •Prior treatment with hypomethylating agent (HMA) (e.g., azacitadine, decitabine)
- •History of MDS IPSS risk score of greater than 1.0
- •Pregnant or lactating women
- •Any severe concurrent disease, infection or comorbidity that, in the judgement of the investigator, would make the patient inappropriate for study entry
- •Oral steroids greater than 10 mg per day. Exceptions: those prescribed for other conditions (such as new adrenal failure, asthma, arthritis) or brief sterioid use (such as tapered dosing for an acute non-MDS condition)
- •History of hepatitis B or C, or HIV
结局指标
主要结局
Hematologic Improvement-Erythroid (HI-E) rate
时间窗: At 32 weeks of treatment
Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)
次要结局
- Duration of response(2 years)
- Hematologic Improvement-Neutrophil (HI-N) rate(At 8, 16, 24, & 32 weeks of treatment)
- Evaluation of the relationship between HI-E response, gene expression profiling and response-related variables(2 years)
- Hematologic Improvement-Platelet (HI-P) rate(At 8, 16, 24, & 32 weeks of treatment)
- Unilineage, bilineage, trilineage, and overall HI response rate(2 years)
- RBC Transfusion independence (TI) rate(At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment)
- Cytogenetic response rate(16 weeks, 48 weeks and at the time of first HI response)
- Safety of ezatiostat in this MDS population(At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment)
研究者
研究点 (13)
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