A Phase 2 Study of EMD 121974 as Maintenance Therapy for Patinets With Acute Myeloid Leukemia in Complete Remission
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
This randomized phase II trial is studying how well cilengitide works in treating patients with acute myeloid leukemia. Cilengitide may stop the growth of cancer cells by blocking the enzymes necessary for their growth
详细描述
PRIMARY OBJECTIVES:
I. Determine 10-month relapse-free survival of patients with acute myeloid leukemia in first complete remission treated with cilengitide as maintenance therapy.
SECONDARY OBJECTIVES:
I. Determine overall survival of patients treated with this drug. II. Determine the safety and toxicity of this drug in these patients. III. Determine the biological activity of this drug in cells from these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of acute myeloid leukemia (AML)
- •In first complete remission after at least 1 course of induction chemotherapy AND 1-2 courses of consolidation chemotherapy for newly diagnosed AML, as defined by the following:
- •No evidence of disease in bone marrow
- •Recovery of peripheral blood counts
- •Platelet count > 100,000/mm^3
- •Absolute neutrophil count > 1,500/mm^3
- •Must be able to start study medication within 60 days from the start of the last consolidation therapy
- •Must not have a suitable donor, refused, or ineligible for hematopoietic stem call transplantation
- •None of the following AML subtypes or chromosomal translocations:
- •Acute promyelocytic leukemia
- •Performance status - ECOG 0-2
- •Performance status - Karnofsky 60-100%
- •See Disease Characteristics
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •ALT ≤ 2.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •Creatinine clearance > 60mL/min
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study compliance
- •No other uncontrolled illness
- •No prior investigational agents specifically designated as an antiangiogenic agent
- •No concurrent prophylactic hematopoietic colony-stimulating factors
- •See Disease Characteristics
- •Recovered from prior consolidation chemotherapy
- •No other concurrent anticancer therapies
- •No other concurrent investigational cytotoxic agents
排除标准
- 未提供
研究组 & 干预措施
Arm I (low dose cilengitide)
Patients receive cilengitide IV at a lower dose over 1 hour twice weekly for 4 weeks.
干预措施: cilengitide (Drug)
Arm II (higher dose cilengitide)
Patients receive cilengitide IV at a higher dose over 1 hour twice weekly for 4 weeks.
干预措施: cilengitide (Drug)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: From initiation of induction chemotherapy until the first incidence of disease or death due to any cause, assessed up to 2 years
Kaplan-Meier curves will be constructed for each treatment group. Median DFS in each group and corresponding 95% confidence intervals will be estimated. The two treatment groups will be compared using log-rank test.
次要结局
- Toxicity of cilengitide graded using the CTC version 3(Up to 2 years)
- Overall survival(Up to 2 years)