A Pilot Study for Using 18F-FLT PET Imaging To Assess Response In Patients With Myelodysplastic Syndrome (MDS) Being Treated With 5-azacitidine
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- feasibility of using FLT-PET to assess chemotherapy response in AML/MDS
研究概览
简要总结
The main purpose of this study is to see if this tracer can be used to determine how well chemotherapy is working in patients with certain types of leukemia.
详细描述
Primary objectives
- To evaluate if FLT-PET uptake shows variation during the treatment course in subjects with MDS being treated with 5-azacitidine therapy
Secondary objectives 2. To assess FLT-PET uptake heterogeneity within given subjects being treated with 5-azacitidine therapy 3. To generate preliminary data regarding correlation between FLT-PET imaging parameters and clinical responses based on bone marrow aspirate/biopsy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects with previously untreated, Intermediate-2 or High risk myelodysplastic syndrome are eligible. These patients have an international prognostic scoring system (IPSS) score of 1.5 to 3.5 based on bone marrow blast percentage, karyotype, and the number of cytopenias
- •Subjects will receive the standard FDA-approved dose and schedule of 5-azacitidine. This dose is 75mg/m2 SQ or IV daily for seven days with cycles repeated every 28 days
- •The subject's treating physician must have an initial intent of treating with at least four cycles of therapy
- •Subjects must have an ECOG performance status of 0, 1, or 2
- •Subjects must not have been treated with chemotherapy or radiation for another malignancy within the preceding 6 months
- •Subjects must be > 18 years of age
- •Subjects must have a serum creatinine < 2.0 mg/dL and/or calculated GHF 50 ml/min/1.73m (MRDR formula) or greater
- •Subjects must have a serum direct bilirubin < 2.0 mg/dL unless related to Gilbert's syndrome of hemolysis. Alkaline phosphatase, SGOT (AST), and SGPT (ALT) must be less than 4 x upper limit of normal
- •Women must not be pregnant nor breastfeeding
- •Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception
排除标准
- •Subjects who are pregnant or breast feeding
- •Subjects for whom a therapy other than 5-azacitidine is recommended as first line treatment.
- •Allogeneic stem cell transplantation in patients with a suitable donor, lack of comorbidities, and good performance status
结局指标
主要结局
feasibility of using FLT-PET to assess chemotherapy response in AML/MDS
时间窗: 3 years
This pilot study is intended to investigate the feasibility of FLT-PET for early assessment of treatment response in myelodysplastic syndrome and the use of a PET isotope, (18)F-FLT, in the imaging of bone marrow in subjects with MDS. The objectives will help gather initial information for a future, larger, more definitive study.
次要结局
未报告次要终点