Phase I/II Study of Bortezomib and Low Dose Cytarabine in the Treatment of High-risk Myelodysplastic Syndromes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 30
- 主要终点
- Efficacy and safety evaluation
研究概览
简要总结
We are evaluating the efficacy of the association of Low dose Cytarabine in association with Bortezomib in the treatment of patients diagnosed with high risk Myelodysplastic syndromes. Our aim is to decrease transfusion requirements and if possible induce a complete or at least a partial remission.
详细描述
Four cycles of treatment are proposed at 28 day intervals in an ambulatory setting
Cycle 1 :
- Cytarabine 10 mg /m2/day subcutaneous injection for 14 days
- Bortézomib 1,5mg/m2 days 1,4,8,11
Cycles 2, 3, 4 :
- Cytarabine 20 mg /m2/j subcutaneous injections for 14 days
- Bortézomib 1,5mg/m2 days 1,4,8,11
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MDS with IPSS scores Int-2 or High
- •Life expectancy greater than 6 months
- •No other available treatment options
排除标准
- •MDS with IPSS scores Low or Int-1
- •> 30% bone marrow blasts
- •clinical neuropathy of greater than grade 2
- •ECOG Score 3 or 4
- •Creatinine clearance of < 30 ml/min
- •Pregnant patients or lactating mothers
- •Patients having received intensive chemotherapy in the 3 months prior to inclusion
- •Patients with uncontrolled pulmonary, cardiac, neurological, gastro-intestinal or genito-urinary disorders
结局指标
主要结局
Efficacy and safety evaluation
时间窗: 18 mois
A total of 138 cycles were administered. The median number of cycles administered was 3·2 (range 0·5-8). Thirty-six patients (84%) received at least two cycles and 17 (40%) received the planned four cycles, six responding patients received 1-4 additional cycles. Treatment was dis- continued in the responding patients at progression to AML or for toxicity. The most common treatment-related adverse events were related to myelosuppression . Neutropenia (Grade 4) and thrombocytopenia (Grade 4) were seen during treatment in 51% and 46% of the patients, respectively. Three of the patients with pre-treatment Grade 0-2 neutropenia and thrombocytopenia developed Grade 3-4 toxicity complicated by infection and bleeding. Grade 3-4 neutropenia was responsible for infection in six patients. Grade 3-4
Complete Response
Partial Response
次要结局
- Hematological Improvement