A Phase II Study of Arsenic Trioxide in Patients With Relapsed and/or Refractory Acute Myeloid Leukemia (AML) and Mutated Nucleophosmin 1 (NPM1) Gene
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Rate of complete remission following arsenic trioxide induction
研究概览
简要总结
This phase II trial studies how well arsenic trioxide works in treating patients with relapsed or refractory acute myeloid leukemia. Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
详细描述
PRIMARY OBJECTIVES:
I. Determine the complete remission rate of relapsed and refractory acute myeloid leukemia (AML) patients with Mutated Nucleophosmin 1 (NPM1) gene.
SECONDARY OBJECTIVES:
I. Determine the duration of remission in these patients. II. Determine the in vivo biological effect of arsenic trioxide in AML with mutated NPM1.
OUTLINE:
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
- •AML, any French- American- British (FAB) subtype except M3, with confirmed mutation in the NPM1 gene
- •Relapsed and/or refractory AML from any duration of complete remission (CR); any number of prior therapies allowed
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2, life expectancy > 3 months
- •Serum creatinine =< 2.0 mg/dL
- •Bilirubin =< 2.0 mg/dL
- •Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 3 x upper limit of normal (ULN)
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies; pregnancy tests must be obtained in women; sexually active males or females may not participate unless they have agreed to use an effective contraceptive method
- •Patients who are currently receiving another investigational drug
- •Patients who are currently receiving other anti-cancer agents
- •Uncontrolled systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
- •Known hypersensitivity to arsenic trioxide
研究组 & 干预措施
Treatment (arsenic trioxide)
Patients receive arsenic trioxide IV over 1-2 hours daily for up to 45 days. Patients achieving complete remission, receive arsenic trioxide IV over 1-2 hours daily 5 days a week for 4 weeks. Treatment repeats every 8 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
干预措施: arsenic trioxide (Drug)
Treatment (arsenic trioxide)
Patients receive arsenic trioxide IV over 1-2 hours daily for up to 45 days. Patients achieving complete remission, receive arsenic trioxide IV over 1-2 hours daily 5 days a week for 4 weeks. Treatment repeats every 8 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Rate of complete remission following arsenic trioxide induction
时间窗: After 4 weeks of therapy
次要结局
- Median duration of remission(Time from documented complete remission until time of disease relapse, assessed up to 2 years)