NCT00283439已完成1 期
An Open Label Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 for Treatment of Severe Thrombocytopenia Due to Multi-Cycle Chemotherapy in Adult Subjects With Lymphoma.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 39
- 主要终点
- Change in Platelet Nadir
研究概览
简要总结
The purpose of this study is to identify a well-tolerated, effective dose and schedule of AMG 531 for the treatment of Chemotherapy Induced Thrombocytopenia (CIT) in subjects with lymphoma receiving multi-cycle chemotherapy.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Histologically confirmed Hodgkin's lymphoma or Non-Hodgkin's lymphoma receiving Q14, Q21, or Q28 day CHOP, ICE, ESHAP, or DHAP chemotherapy; with or without Rituximab
- •Has adequate bone marrow function; platelet count > 100 x 10^9/L on the day of initiation of the on study chemotherapy of the next treatment cycle and absolute neutrophil count, ANC > or = 1 x 10^9/L, and hemoglobin > or = 9.5 g/dL
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Has adequate liver function
- •must be able to receive the same chemotherapy regimen during the first treatment cycle as was received during the prior qualifying cycle
- •must experience Common Terminology Criteria (CTC) grade 3 or 4 thrombocytopenia (platelet count < 50 x 10^9/L) as a result of the chemotherapy administered in the cycle immediately preceding study entry
- •has serum creatinine concentration < or = 2 mg/dl
排除标准
- •More that 1 prior relapse chemotherapy regimen
- •Sepsis, disseminated coagulation or any other condition that may exacerbate thrombocytopenia
- •Significant bleeding (CTC grade 3 or 4)
- •History of thromboembolic disease
- •Subjects who are identified by clinical history and/or serological testing to have either acute or chronic hepatitis B or C infection or to be HIV positive
- •Use of any nitrosourea or mitomycin-C
- •Has received any thrombocytopenic growth factor
- •Has received a marrow or peripheral blood stem cell infusion
- •Known hypersensitivity to any recombinant E. coli-derived product
结局指标
主要结局
Change in Platelet Nadir
时间窗: 32 weeks
Change in platelet nadir from the previous qualifying cycle to the first treatment cycle.
次要结局
- Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia(32 weeks)
- Duration of Grade 3 or 4 Thrombocytopenia(32 weeks)
- Percentage of Subjects That Received Platelet Transfusions(32 weeks)
研究者
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