NCT00840684已完成1 期
A PHASE I-II MULTICENTER STUDY OF THE CLORETAZINE-DAUNORUBICIN-ARACYTINE COMBINATION FOR THE TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) WITH UNFAVORABLE CYTOGENETICS
Institut Paoli-Calmettes2 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2009年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Dose-limiting toxicity (phase I)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as laromustine, daunorubicin, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of laromustine when given together with daunorubicin and cytarabine in treating patients with acute myeloid leukemia.
详细描述
OBJECTIVES:
Primary
- To determine the dose of laromustine that can be combined with daunorubicin hydrochloride and cytarabine in patients with previously untreated acute myeloid leukemia with unfavorable cytogenetics. (Phase I)
- To determine the complete remission rate of this regimen as induction therapy. (Phase II)
Secondary
- To determine the complete response rate.
- To determine the safety profile of this regimen.
- To determine the overall and relapse-free survival.
- To evaluate the prognostic value of the molecular markers FLT3, duplications of MLL, and Evi-1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of acute myeloid leukemia (AML)
- •Untreated disease
- •No promyelocytic AML
- •Unfavorable prognosis, defined as at least one of the following:
- •Cytogenetic abnormalities including -5/5q-, -7/7q-, 3q, 11q23, t(6;9), and complex abnormalities (≥ 3 clonal abnormalities), excluding t(9;11)
- •Baseline hyperleukocytosis ≥ 100 g/L or progression of leukocytosis or extra-medullary localizations despite treatment with hydroxyurea
- •No AML with favorable or intermediate prognosis
- •No AML secondary to myelodysplastic syndrome diagnosed within the past 3 months or myeloproliferative syndrome
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Total bilirubin < 35 μmol/L
- •Transaminases < 2.5 times upper limit of normal in the absence of leukemia-related abnormalities
- •Creatinine < 170 μmol/L OR creatinine clearance ≥ 50 mL/min in the absence of leukemia-related abnormalities
- •Not pregnant or nursing
- •Normal cardiac function by LVEF (echographic ≥ 40% or isotopic ≥ 50%)
- •Affiliated with a social security system
- •No uncontrolled or severe cardiovascular disease, including any of the following:
- •Myocardial infarction within the past 3 months
- •Cardiac insufficiency
- •Uncontrolled arrhythmia
- •No other active cancer within the past year except for basal cell carcinoma of the skin or epithelioma in situ of the cervix
- •No patients deprived of freedom or under guardianship (including temporary guardianship)
- •No psychological, familial, geographical, or social situations that preclude follow-up
- •No other contraindications to study treatment
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Prior hydroxyurea allowed
- •No concurrent disulfiram
- •No concurrent participation in another study with an experimental drug
排除标准
- 未提供
结局指标
主要结局
Dose-limiting toxicity (phase I)
Rate of complete remission (phase II)
次要结局
未报告次要终点
研究者
研究点 (2)
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