Phase II Study of Low-Dose Decitabine (5-AZA-2'-Deoxycytidine) in Myelodysplastic Syndrome (MDS) Post Azacytidine (AZA) Failure
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Overall Response
研究概览
简要总结
To study if decitabine can help to control Myelodysplastic Syndrome (MDS) in patients who have failed on therapy with azacytidine, the current standard of therapy.
详细描述
Methylation is a change that occurs to Deoxyribonucleic acid (DNA) that affects gene usage in human cells. Abnormal methylation is very common in leukemias, which is a related disease to MDS. Decitabine is a new drug that blocks DNA methylation. Researchers want to find out if blocking methylation will help control MDS.
Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a physical exam, routine blood tests (between 4-6 tablespoons), and a bone marrow aspirate. To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. Women who are able to have children must have a negative blood or urine pregnancy test.
If you are found to be eligible to take part in this study, you will receive decitabine by vein over one hour, once a day, for 5 days (1 course). If this is not possible due to complications, you will receive the drug as an injection under the skin twice a day for 5 days (1 course). Treatment will be given every 4 to 8 weeks depending on how well your blood counts recover.
After completing 8-12 weeks of therapy, response will be evaluated. If the response to treatment is good, treatment with decitabine will continue. Decitabine treatment may be continued for up to 12 courses, or as long as it is judged best to control the leukemia.
During this study, you will need to visit your doctor periodically for physical exams and measurement of vital signs. The frequency of doctor visits will vary depending on your physical condition, but will be required at least once a month.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MDS and 5% or more marrow blasts, or IPSS risk intermediate 1-2 or high risk; or chronic myelomonocytic leukemia. Patients must have failed therapy with azacytidine.
- •Performance status 0-2 (ECOG scale); adequate hepatic (bilirubin < 2 mg/dl) and renal functions (creatinine <2mg/dl); New York Heart Association (NYHA)cardiac status III-IV excluded.
- •Signed informed consent.
- •No prior intensive combination chemotherapy or high-dose ara-C (>/= 1g/m*2 per dose). Prior biologic therapies, targeted therapies and single agent chemotherapy allowed.
- •Patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease. Use of hydroxyurea for patients with rapidly proliferative disease is allowed for the first two weeks on therapy.
排除标准
- •Nursing and pregnant females are excluded. Patients of childbearing potential should practice effective methods of contraception. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •Patients with active and uncontrolled infections.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
研究组 & 干预措施
Decitabine
20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
干预措施: Decitabine (Drug)
结局指标
主要结局
Overall Response
时间窗: Blood tests baseline and after completing 8-12 weeks of therapy
Participants with Overall Response, categorized as 'Complete Response' to represent remission or 'No Complete Response' for lack of remission. Response evaluation after completing one course of therapy (8-12 weeks), then bone marrow aspiration to document remission every 1-3 courses.
次要结局
未报告次要终点