NCT00620321已完成2 期
An Open-Label Phase 2 Trial of LY2181308 Sodium Administered in Combination With Idarubicin and Cytarabine to Patients With Refractory or Relapsed Acute Myeloid Leukemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (Safety Profile)
研究概览
简要总结
The purpose of this study is to understand the safety profile of LY2181308 sodium administered in combination with idarubicin and cytarabine to patients with relapsed or refractory acute myeloid leukemia (AML).
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
- •Patients who have a diagnosis of acute myeloid leukemia that is relapsed or refractory to at least 1 prior treatment for leukemia, or patients with chronic myeloid leukemia (CML) who are in myeloid blast crisis which have failed at least 1 previous tyrosine kinase inhibitor (TK1). A baseline bone marrow assessment is required less than or equal to 96 hours prior to the first dose of study drug.
- •Must have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, cancer related hormone therapy, or other investigational therapy for at least 21 days for myelosuppressive agents (such as cytarabine, daunorubicin, and gemtuzumab ozogamicin) or 14 days for non-myelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (such as neurotoxicity, diarrhea, and mucositis) except for residual myelosuppression and alopecia. Hydroxyurea is permitted to control the peripheral blast cell count, but must be stopped at least 24 hours before study drug administration.
- •Must have adequate organ function.
- •Females must have a negative pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 6 months following the last dose of study drug.
- •Patients must be at least 18 years old.
排除标准
- •Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a non-myelosuppressive or myelosuppressive agent, respectively.
- •Patients with acute promyelocytic leukemia (APML).
- •Major surgery within 4 weeks of study enrollment.
- •Patients with serious pre-existing medical conditions (at the discretion of the investigator). Because of the known cardiac toxicity of anthracyclines, patients with pre-existing ejection fraction (EF) less than or equal to 45% should not participate in this study. No patient should exceed the maximum exposure of anthracycline doses (for example, idarubicin greater than 120 mg/m²).
- •Patients with a second malignancy that could affect the interpretation of the results.
- •Patients with leukemic involvement of the central nervous system (CNS) by spinal fluid cytology or imaging.
- •Patients with known coagulopathy or bleeding disorder, other than leukemia related thrombocytopenia. Patients with severe of life threatening bleeding refractory to platelet transfusions are also excluded.
- •Concomitant anticoagulant therapy (with the exception of heparinized saline to maintain the patency of central venous catheters).
- •Women who are pregnant or breast feeding.
- •Patients with a known hypersensitivity to oligonucleotides, idarubicin, and/or cytarabine.
研究组 & 干预措施
LY2181308 sodium, idarubicin, cytarabine
Experimental
干预措施: LY2181308 sodium (Drug)
LY2181308 sodium, idarubicin, cytarabine
Experimental
干预措施: cytarabine (Drug)
LY2181308 sodium, idarubicin, cytarabine
Experimental
干预措施: idarubicin (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (Safety Profile)
时间窗: Start of treatment to study completion up to 6.7 months
Data are presented as number of participants who experienced serious adverse events (SAE) and possibly drug-related treatment-emergent adverse events (TEAE) during the study including the 21-day follow-up period. A summary of serious adverse events and other nonserious adverse events regardless of causality is located in the Reported Adverse Events section.
次要结局
- Area Under the Curve of LY2181308 Over the Dosing Interval(Day 3: 0,12,24,36,48,60,72,84,96,108,120,132 hours)
- Pharmacodynamics: Number of Participants With Survivin Protein Expression(6 Months)
- Percentage of Participants With Response to LY2181308 Sodium in Combination With Idarubicin and Cytarabine (Remission Rates)(Baseline to progression of disease or death up to 6 months)
- Relapse-Free Survival(Baseline to progression of disease or death up to 6 months)
- Change From Baseline in Survivin Index at Day 2(Baseline, Day 2)
研究者
研究点 (1)
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