NCT01235117已完成2 期
A Phase 2 Study of Azacitidine in Chronic Myelomonocytic Leukemia (CMML)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety and tolerability
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying the side effects of azacitidine and to see how well it works in treating patients with chronic myelomonocytic leukemia.
详细描述
OBJECTIVES:
Primary
- To assess the safety and tolerability of azacitidine in patients with chronic myelomonocytic leukemia (CMML).
- To assess the overall response rate in these patients.
Secondary
- To assess the incidence of clinical remission/complete remission or partial response in these patients.
- To assess hematological improvement in patients treated with this drug.
- To assess the overall survival of patients treated with this drug.
- To assess progression-free survival of patients treated with this drug.
- To assess the time to acute myeloid leukemia (AML) transformation of CMML.
- To assess the time to death or AML transformation of CMML.
- To assess the biological correlates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of 1 of the following:
- •All chronic myelomonocytic leukemia (CMML)-2 patients
- •CMML-1 patients meeting any of the following criteria:
- •Symptomatic bone marrow failure/myeloproliferation defined as any of the following:
- •Red cell transfusion dependence and pre-transfusion hemoglobin < 9.0 g/dL
- •Symptomatic anemia (hemoglobin < 11.5 g/dL)
- •Thrombocytopenia (platelet count < 50 x 10^9/L)
- •Symptomatic bleeding due to platelet functional defect or disseminated intravascular coagulation (DIC)/fibrinolysis
- •White cell count (WCC) > 50 x 10^9/L
- •Düsseldorf Score of intermediate or high risk for proliferative CMML-1 (i.e., WCC > 12 x 10^9/L)
- •International Prognostic Scoring System (IPSS) score of intermediate-2 or high risk for non-proliferative CMML-1 (i.e., WCC < 12 x 10^9/L)
- •Systemic symptoms including weight loss with no alternative explanation (10% of baseline weight within the past 6 months)
- •Symptomatic splenomegaly
- •Symptomatic extramedullary involvement (e.g. skin infiltration or serous effusions)
- •No CMML with eosinophilia and 5q33 abnormality
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2
- •Creatinine ≤ 2 times upper limit of normal
- •Not pregnant or nursing
- •Negative urine pregnancy test
- •Fertile patients must use at least 2 forms of effective contraception during study and for 3 months after completion of study therapy
- •No other active malignant disease including basal cell or squamous cell carcinoma of the skin
- •No known HIV or infectious hepatitis B or hepatitis C
- •No active infection
- •No known hypersensitivity to azacitidine or mannitol
- •PRIOR CONCURRENT THERAPY:
- •At least 28 days since other prior experimental drug or therapy
- •No prior chemotherapy for this disease except hydroxycarbamide
- •No other concurrent anticancer or investigational agents
排除标准
- 未提供
结局指标
主要结局
Safety and tolerability
Overall response rate
次要结局
- Incidence of clinical remission/complete remission or partial response according to International Working Group (IWG) criteria
- Hematological improvement according to IWG criteria
- Overall survival
- Progression-free survival
- Time to acute myeloid leukemia (AML) transformation of CMML
- Time to death or AML transformation of CMML
- Biological correlates
研究者
研究点 (2)
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