Phase II Study of NRX 195183 Therapy for Patients With Relapsed or Refractory Acute Promyelocytic Leukemia
试验速览
- 阶段
- 2 期
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Complete Remission
研究概览
简要总结
The purpose of this study is to determine whether NRX 195183 is effective in the treatment of relapsed or refractory Acute Promyelocytic Leukemia
详细描述
A common current therapeutic approach to APL uses oral ATRA and chemotherapy in induction and consolidation. This approach has significantly improved survival in newly diagnosed APL patients. However, approximately 30% of patients relapse. Recently, an approach involving the combination of oral ATRA and arsenic trioxide has been tested. The prognosis for relapsed patients is very poor. This study seeks to investigate NRX 195183 monotherapy in patients who have failed or are resistant to or are intolerant of any prior therapy.
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
- •Clinical diagnosis of APL morphology or FAB M3 variant confirmed by RT-PCR assay or chromosome analysis/FISH showing t(15:17) translocation. Patients must also have relapse from, resistance to or intolerance of any one or more of the following therapies:
- •Cytotoxic chemotherapy
- •Arsenic trioxide
- •Patients must be 18 or older.
- •Bilirubin equal or less than 1.5 times the upper limit of normal.
- •Creatinine equal or less than 1.5 times the upper limit of normal.
- •Patients entered into this study should be non-pregnant and non-nursing and should not plan on becoming pregnant while on treatment. Treatment under this protocol would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective means of birth control. There is an extremely high risk that a severely deformed infant will result if NRX 195183 is administered during pregnancy.
排除标准
- •Non-APL, AML patients should be excluded from the study.
- •Other serious illnesses which would limit survival to 6 months.
- •Psychiatric conditions which would prevent compliance with treatment or informed consent.
- •Uncontrolled or severe cardiovascular disease. This would include history of a recent acute myocardial infarction, uncontrolled congestive heart failure, or active angina.
- •AIDS or HIV positive patients, although HIV test is not required for accrual.
研究组 & 干预措施
1
干预措施: NRX 195183 Soft Gelatin Capsule (Drug)
结局指标
主要结局
Complete Remission
时间窗: 90 Days
次要结局
- Molecular Complete Remission(9 months)