CTRI/2012/07/002836进行中（未招募）3 期
An open label, parallel, randomized clinical study to compare Azacitidine with best supportive care in patients with Myelodysplastic syndrome (MDS)
ATCO Pharma Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Male and female MDS patients ï?³ 18 years of age with a diagnosis of FAB criteria-defined refractory anemia (RA), RA with ringed sideroblasts (RARS). RA with excess blasts (RAER), RA with excess blasts in transformation (RAEB-T), or chronic myelomonocytic leukemia (CMML).
- •Life expectancy more than 7 months.
- •RA or RARS patients must meet at least one of the following criteria: hemoglobin lower than 11.0 g/dL with requirements for at least one RBC transfusion every 28 days; thrombocytopenia with platelet count lower than 100 X 109/L, or neutropenia with absolute neutrophil count lower than 1.5 X 109 /L
- •Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
- •Laboratory screening
- •No erythropoietin, corticosteroids, interferon, or retinoids usage within 1 month before study
- •Patients willing to give informed consent
- •No prior history of leukemia
- •Patients must be willing to practice birth control during and for 6months after treatment with Azacitidine
排除标准
- •1.Patients with secondary MDS, a history of AML or other malignant disease.
- •2.Patients with uncorrected red cell folate deficiency or vitamin B12 deficiency.
- •3.Patients with a history of severe cardiac or pulmonary disease, or received radiation therapy, chemotherapy, or other investigational drugs within the previous 30 days.
- •4.Female patients, who are pregnant
研究者
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