Potential Utility of Peroxisome Proliferator-activated Receptor Gamma Agonists in the Eradication of Chronic Myeloid Leukemia Stem Cells: Myth or Truth?
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Rate of major molecular response(MMR) at 12 months
研究概览
简要总结
Assessment of patients response and expression levels of CITED2 and HIF2a genes on adding pioglitazone to imatinib therapy.
详细描述
Eligible denovo CML patients will be treated by combination drug therapy of imatinib 400 mg plus pioglitazone (15 - 30mg).They will be on follow up for their complete blood count (CBC), chemistry profile and random blood sugar every 2 weeks. After 3, 6 and 12 months of treatment the patients response will be evaluated and compared with the obtained responses of a historical control group. Assessment of the hypoxia induced factor 2 alpha (HIF2a) gene and CBP/p300-interacting transactivator with glutamic acid (E) and aspartic acid (D)-rich tail 2 (CITED2) gene expression levels before and after 6 months of treatment will be additionally evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CML cases (BCR-ABL1 positive)
排除标准
- •Accelerated or blastic crisis
- •Atypical CML (BCR-ABL1 negative)
- •Chronic myelomonocytic leukemia (CMML)
- •Pregnant or breastfeeding females.
- •Patients with severe organ dysfunction
研究组 & 干预措施
Interventional no
Patients treated with both drugs ( imatinib and pioglitazone)
干预措施: Pioglitazone 15mg (Drug)
结局指标
主要结局
Rate of major molecular response(MMR) at 12 months
时间窗: 1 year
Percentage of patients obtaining MMR at 12 months
Impact of treatment on the expression levels of stemness genes
时间窗: 6 months
Follow up the expression of CITED2 and HIF2a genes pattern
次要结局
- Impact of treatment on the rate of transformation(1 years)
研究者
Basma Atef
Assistant lecturer of Hematology (Internal medicine department)
Mansoura University