NCT00528333已完成2 期
A Phase IIB, Randomized, Double-Blinded, Placebo-Controlled Study of Low Dose Cytarabine and Lintuzumab Compared to Low Dose Cytarabine and Placebo in Patients 60 Years of Age and Older With Previously Untreated AML
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Seagen Inc.
- 入组人数
- 211
- 试验地点
- 20
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to assess whether there is a survival benefit with lintuzumab given in combination with low dose cytarabine versus low dose cytarabine and placebo in patients with AML.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Untreated AML that occurred de novo, after prior exposure to chemotherapy for a separate malignancy, or evolved from an antecedent hematologic disorder.
- •After being informed of the potential benefits and risks of available treatment options, patients must have declined intensive chemotherapy for AML.
- •At least 20% blasts in blood or marrow.
- •Must have a minimum of 50% leukemic blasts that express CD
- •ECOG performance status score of 0 to
- •WBC less than 30,000/µL
排除标准
- •No known diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia.
- •No other active systemic malignancies treated with chemotherapy within the last 12 months.
- •Must not have received previous chemotherapy (except hydroxyurea) for AML.
- •Must not have significantly abnormal kidney or liver disease.
- •Must not have known human immunodeficiency virus (HIV).
研究组 & 干预措施
1
Experimental
Lintuzumab plus low dose cytarabine
干预措施: Lintuzumab (SGN-33) (Drug)
1
Experimental
Lintuzumab plus low dose cytarabine
干预措施: Low dose cytarabine (Drug)
2
Active Comparator
Placebo plus low dose cytarabine
干预措施: Low dose cytarabine (Drug)
2
Active Comparator
Placebo plus low dose cytarabine
干预措施: Placebo (Drug)
结局指标
主要结局
Overall survival
时间窗: 12 months
次要结局
- Complete blood counts (CBC), Transfusion Requirements, Infections or Fevers of Unknown Origin Requiring Hospitalization or IV Antibiotics(13 months)
研究者
研究点 (20)
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